A Pilot Study Evaluating the Use of mTor Inhibitor Sirolimus in Children and Young Adults With Desmoid- Type Fibromatosis

Recruiting Status:

Recruiting

Last Updated:

July 20, 2018

Sponsor:

Maine Medical Center

ClinicalTrials.gov #:

NCT01265030

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE up to 29 Years   (Child, Adult)

Description:

Desmoid- type fibromatosis (or desmoid tumor ) represents an intermediate grade neoplasm with a striking predilection for locally invasive growth and recurrence following resection. It occurs in children as well as young adults. As a typically localized disease, the historical standard of care for treatment has been surgical resection, with or without ionizing radiation. In some cases where surgical resection or radiation is not feasible, chemotherapy has been used. Two clinical trials conducted in the Pediatric Oncology Group (POG) and the Children's Oncology Group (COG) evaluated the role for either low intensity or non-cytotoxic chemotherapy for children with desmoid tumor that is not amenable to standard therapy. These were largely empirical treatment strategies or based on somewhat anecdotal observations. By better understanding desmoid tumor biology, even more effective therapy targeting a particular protein that is central to the disease can be developed. Desmoid tumor
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National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES)

Recruiting Status:

Recruiting

Last Updated:

July 12, 2018

Sponsor:

Centre Oscar Lambret

ClinicalTrials.gov #:

NCT02867033

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE Child, Adult, Older Adult

Description:

The purpose of this study is to constitute the French largest Aggressive fibromatosis cohort.
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PAZOPANIB Efficacy and Tolerance in Desmoids Tumors

Recruiting Status:

Recruiting

Last Updated:

October 5, 2017

Sponsor:

Institut Bergonié

ClinicalTrials.gov #:

NCT01876082

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

Desmoids tumors are benign soft tissues tumors characterized by aggressiveness and potential local recurrence. There is a female predominance with a sex ratio of 2/1 and median age at diagnosis is about 30 years. Only a complete surgical excision is recommended in desmoids tumors . Some forms of desmoid tumors are recurrent and/or symptomatic and are not accessible to a conservative surgical treatment. In these clinical situations, only a medical treatment may achieve tumor control and quality of life maintenance. Place of systemic treatments in the management of desmoids tumors is poorly evaluated. Regarding chemotherapy, methotrexate and vinblastine protocol is actually the best evaluated combination, which allowed observing objective response rate between 40 and 75%. Toxicity was mainly marked by the risk of haematological toxicity. Pazopanib is an inhibitor of multi-target tyrosine kinase, in oral form, with selective type receptors -1, -2 and -3 of VEGF receptors on the
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Nirogacestat for Adults With Desmoid Tumor /Aggressive Fibromatosis (DT/AF)

Recruiting Status:

Recruiting

Last Updated:

May 7, 2019

Sponsor:

SpringWorks Therapeutics, Inc.

ClinicalTrials.gov #:

NCT03785964

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

This study evaluates nirogacestat in the treatment of desmoid tumor /aggressive fibromatosis (DT/AF). Half of the participants will receive nirogacestat while the other half will receive placebo.
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Phase I, Open-label, Non-randomized Study to Evaluate Safety of BC2059

Recruiting Status:

Recruiting

Last Updated:

February 15, 2019

Sponsor:

Iterion Therapeutics

ClinicalTrials.gov #:

NCT03459469

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

Phase I, open-label, non-randomized study to evaluate safety of BC2059 administered intravenously to subjects with proven primary or recurrent desmoid tumor that is unresectable and symptomatic or progressive.
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A Pilot Study of Intralesional Injection of Triamcinolone Acetonide for Desmoid Tumors

Recruiting Status:

Recruiting

Last Updated:

January 30, 2019

Sponsor:

Mayo Clinic

ClinicalTrials.gov #:

NCT03627741

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years to 89 Years   (Adult, Older Adult)

Description:

There is research supporting treatment of superficial fibromatoses (palmar fibromatosis and keloids) with triamcinolone acetonide injections. These lesions are histologically similar to deep fibromatoses (desmoid tumors ). Currently there is little literature evaluating the response of desmoid tumors to injections of triamcinolone acetonide. The investigators aim to perform a pilot study evaluating the response of desmoid tumors to intralesional triamcinolone. If positive results are observed (based on RECIST criteria), then a phase II study will be initiated.
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Trial of Nab-paclitaxel in Patients With Desmoid Tumors and Multiply Relapsed/Refractory Desmoplastic Small Round Cell Tumors and Ewing Sarcoma

Recruiting Status:

Recruiting

Last Updated:

September 8, 2017

Sponsor:

Grupo Espanol de Investigacion en Sarcomas

ClinicalTrials.gov #:

NCT03275818

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 6 Months to 80 Years   (Child, Adult, Older Adult)

Description:

A two-cohort, fase II, open-label, non-randomized, multicenter clinical trial. 14 sites in Spain. Cohort 1: Subjects with desmoid tumor (DT) Cohort 2: Subjects with desmoplastic small round cell tumor or Ewing sarcoma (DSRCT and ES) Nab-paclitaxel (ABRAXANE) will be administered as follows: Age ≥ 21 and ≤ 80 years: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days Age ≥ 6 months and ≤ 20 years: 240 mg/m2 days 1, 8 and 15 in cycles of 28 days Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason. The main goal is to determine the objective response rate (ORR), using RECIST 1.1 criteria and to
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Safety and Efficacy Study Using 5-ALA Oral Administration as an Adjuvant Therapy on the Rate of Local Tumor Recurrence in Patients Who Have Desmoids Tumors

Recruiting Status:

Recruiting

Last Updated:

October 31, 2013

Sponsor:

michal roll

ClinicalTrials.gov #:

NCT01898416

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

The purpose of this study is to evaluate the efficacy of preoperative 5-ALA oral administration and subsequently intraoperative tumor bed phototherapy with red light laser, as an adjuvant therapy on the 3 years rate of local tumor recurrence in patients with desmoid tumors . To evaluate the Safety of 5-ALA administration. 5 years local recurrence rate.
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Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

Recruiting Status:

Recruiting

Last Updated:

May 16, 2019

Sponsor:

National Cancer Institute (NCI)

ClinicalTrials.gov #:

NCT02834013

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors . Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. This trial enrolls participants for the following cohorts based on condition: Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx. Epithelial tumors of major salivary glands Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location Undifferentiated carcinoma of gastrointestinal (GI) tract Adenocarcinoma with variants of small intestine Squamous cell carcinoma with variants of GI tract (stomach small i
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Optional Sub-study to Intraoperative Imaging With ICG Registry

Recruiting Status:

Recruiting

Last Updated:

September 12, 2018

Sponsor:

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov #:

NCT02651246

Genders:

Sexes Eligible for Study: All

Ages:

18 Years and older   (Adult, Older Adult)

Description:

The primary goal of this optional sub-study is to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed.
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MR-guided High Intensity Focused Ultrasound (HIFU) on Pediatric Solid Tumors

Recruiting Status:

Recruiting

Last Updated:

April 3, 2018

Sponsor:

AeRang Kim

ClinicalTrials.gov #:

NCT02076906

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE up to 30 Years   (Child, Adult)

Description:

The purpose of this study is to determine if Magnetic Resonance guided High Intensity Focused Ultrasound ablative therapy is safe and feasible for children, adolescents, and young adults with refractory or relapsed solid tumors .
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Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies

Recruiting Status:

Recruiting

Last Updated:

February 21, 2019

Sponsor:

Cellestia Biotech AG

ClinicalTrials.gov #:

NCT03422679

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

This is a phase I/II, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of CB-103.
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Project: Every Child for Younger Patients With Cancer

Recruiting Status:

Recruiting

Last Updated:

April 16, 2019

Sponsor:

Children's Oncology Group

ClinicalTrials.gov #:

NCT02402244

Genders:

Sexes Eligible for Study: All

Ages:

up to 25 Years   (Child, Adult)

Description:

This research trial studies the Project: Every Child for younger patients with cancer . Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.
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Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction

Recruiting Status:

Recruiting

Last Updated:

April 10, 2018

Sponsor:

Jeffrey E Janis, MD

ClinicalTrials.gov #:

NCT02228889

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years to 99 Years   (Adult, Older Adult)

Description:

The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.
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Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer

Recruiting Status:

Recruiting

Last Updated:

May 2, 2019

Sponsor:

National Cancer Institute (NCI)

ClinicalTrials.gov #:

NCT02961374

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years to 69 Years   (Adult, Older Adult)

Description:

This phase II trial studies the side effects of erlotinib hydrochloride and how well it works in reducing duodenal polyp burden in patients with familial adenomatous polyposis at risk of developing colon cancer . Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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Phase II Trial of the Gamma-Secretase Inhibitor PF-03084014 in Adults With Desmoid Tumors /Aggressive Fibromatosis

Recruiting Status:

Active, not recruiting

Last Updated:

May 2, 2019

Sponsor:

National Cancer Institute (NCI)

ClinicalTrials.gov #:

NCT01981551

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years to 120 Years   (Adult, Older Adult)

Description:

Background: Desmoid tumors (also known as aggressive fibromatosis ), are rare, locally invasive, slow-growing soft-tissue tumors . The disease can be either asymptomatic or be associated with severe loss of organ function and significant morbidity. Treatment with the selective small-molecule Gamma-secretase inhibitor PF-03084014 caused significant tumor shrinkage in patients with unresectable desmoid tumors in an early phase clinical trial. The Notch pathway is a key regulator of cell differentiation, proliferation and apoptosis; aberrant signaling via the Notch pathway is associated with carcinogenesis. Objectives: Primary: Determine the response rate (CR+PR) of PF-03084014 in patients with desmoid tumors /aggressive fibromatosis Secondary: Assess symptom measures at baseline and on study; perform genotyping for germline and somatic mutations in APC and CTNNB1 genes; correlate clinical response to therapy with genotyping data; and assess mod
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18F-FES PET/CT in Imaging Patients With Desmoid Tumors

Recruiting Status:

Active, not recruiting

Last Updated:

April 11, 2018

Sponsor:

Vanderbilt-Ingram Cancer Center

ClinicalTrials.gov #:

NCT02374931

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

This pilot clinical trial studies fluorine (F)-18 16 alpha-fluoroestradiol (18F-FES) positron emission tomography (PET)/computed tomography (CT) in imaging patients with desmoid tumors . 18F-FES binds to estrogen receptors, which are present on desmoid tumors , and gives off radiation that may be detected by PET and CT scans. The PET/CT scan forms an image that may show where tumor cells with estrogen receptors can be found in the body.
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Imatinib in Patients With Desmoid Tumor and Chondrosarcoma

Recruiting Status:

Active, not recruiting

Last Updated:

April 19, 2018

Sponsor:

Italian Sarcoma Group

ClinicalTrials.gov #:

NCT00928525

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years to 80 Years   (Adult, Older Adult)

Description:

The purpose of this study is to determine whether Imatinib Mesylate is active in diseases - such as Desmoid Tumor and Chondrosarcoma - expressing the receptor for the platelet-derived growth factor (PDGF) both in its isoform alpha and beta
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Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis

Recruiting Status:

Active, not recruiting

Last Updated:

January 17, 2019

Sponsor:

National Cancer Institute (NCI)

ClinicalTrials.gov #:

NCT02066181

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

This randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate in treating patients with desmoid tumors or aggressive fibromatosis . Sorafenib tosylate may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. [Funding Source - FDA OOPD]
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Endoxifen in Adults With Hormone Receptor Positive Solid Tumors

Recruiting Status:

Active, not recruiting

Last Updated:

May 16, 2019

Sponsor:

National Cancer Institute (NCI)

ClinicalTrials.gov #:

NCT01273168

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years to 120 Years   (Adult, Older Adult)

Description:

Background: Some types of cancer cells that have hormone receptors on their surfaces need the hormone estrogen to grow. The drug tamoxifen blocks estrogen from binding to the tumor cells, which helps to slow or stop the growth of cancer . Tamoxifen has been approved for treatment of certain types of estrogen-linked cancers , such as breast and ovarian cancer . The experimental drug Z-Endoxifen HCl (endoxifen) is related to tamoxifen, and has been shown to work against similar estrogen-linked cancers . In many cancer patients, tamoxifen is turned into endoxifen by enzymes in the liver; however, not all people have the liver enzymes that can turn tamoxifen into endoxifen, which means that the drug cannot work properly. Taking certain other drugs at the same time as tamoxifen can also keep it from turning into endoxifen. Researchers are interested in determining whether endoxifen tablets are effective in slowing or stopping tumor growth in individuals whose hormone-linke
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Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma

Recruiting Status:

Active, not recruiting

Last Updated:

August 7, 2018

Sponsor:

Children's Oncology Group

ClinicalTrials.gov #:

NCT00919269

Genders:

Sexes Eligible for Study: All

Ages:

up to 50 Years   (Child, Adult)

Description:

The purpose of this study is to collect and store tumor tissue, blood, and bone marrow samples from patients with soft tissue sarcoma that will be tested in the laboratory. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients to test in the laboratory may help the study of cancer .
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Evaluation of the Cryodestruction of Non Abdominopelvic Desmoid Tumors in Patients Progressing Despite Medical Treatment

Recruiting Status:

Completed

Last Updated:

November 17, 2017

Sponsor:

University Hospital, Strasbourg, France

ClinicalTrials.gov #:

NCT02476305

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

Desmoid tumors (DT) are rare tumors (2-4 cases/million/year) that originate from musculoaponeurotic structures. Although they are benign tumors with no metastatic potential, DT are considered as locally aggressive tumors , with local invasiveness and tissue destruction, leading to pain, and disability. Surgery remains the keystone of therapy, but is limited by the anatomical situation of extra-abdominal desmoid (EAD) tumors (chest wall, root members). In patients where surgery is considered, negative-margin resection (R0) is recommended, but this frequently results in cosmetic/functional impairment. Moreover, prognostic impact of R0 resections remains controversial. The outcome after initial surgery depends upon several factors such as age, tumor site, and tumor size as demonstrated by recent data from the French Sarcoma Group. Alternative therapies to DT surgery for front-line or recurrence include NSAID's, anti-estrogens alone or in combination, -interferon, chemotherapy, t
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Vinblastine and Methotrexate in Treating Children With Desmoid Tumors

Recruiting Status:

Completed

Last Updated:

July 25, 2014

Sponsor:

Children's Oncology Group

ClinicalTrials.gov #:

NCT00003019

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE up to 21 Years   (Child, Adult)

Description:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy with vinblastine and methotrexate in treating children who have desmoid tumors that are recurrent or untreatable with surgery or radiation therapy.
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Toremifene in Treating Patients With Desmoid Tumors

Recruiting Status:

Completed

Last Updated:

July 10, 2013

Sponsor:

Advocate Lutheran General Hospital

ClinicalTrials.gov #:

NCT00002595

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 16 Years and older   (Child, Adult, Older Adult)

Description:

RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using toremifene may fight the growth of desmoid tumors by reducing the production of estrogen. PURPOSE: Phase II trial to study the effectiveness of toremifene in treating patients with desmoid tumors .
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Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

Recruiting Status:

Completed

Last Updated:

March 15, 2019

Sponsor:

Children's Oncology Group

ClinicalTrials.gov #:

NCT00068419

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE up to 18 Years   (Child, Adult)

Description:

This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor . Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may fight cancer by blocking the use of estrogen. Combining sulindac with tamoxifen may kill more cancer cells.
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Study to Evaluate Imatinib in Desmoid Tumors

Recruiting Status:

Completed

Last Updated:

May 3, 2017

Sponsor:

Heidelberg University

ClinicalTrials.gov #:

NCT01137916

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

The objective of the present study is to evaluate the activity and safety of imatinib in patients with aggressive fibromatosis who, after receiving the standard therapy, show an inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy.
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Radiation Therapy in Treating Patients With Aggressive Fibromatoses

Recruiting Status:

Completed

Last Updated:

August 27, 2013

Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

ClinicalTrials.gov #:

NCT00030680

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 16 Years and older   (Child, Adult, Older Adult)

Description:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses .
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Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

Recruiting Status:

Completed

Last Updated:

August 30, 2016

Sponsor:

UNICANCER

ClinicalTrials.gov #:

NCT00287846

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years to 120 Years   (Adult, Older Adult)

Description:

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis .
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A Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis )

Recruiting Status:

Completed

Last Updated:

June 27, 2018

Sponsor:

Yonsei University

ClinicalTrials.gov #:

NCT02495519

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 10 Years and older   (Child, Adult, Older Adult)

Description:

Aggressive fibromatosis (AF, also known as desmoid tumor ) is a fibroproliferative neoplasm that typically arises in the abdomen but can develop at other anatomic sites, most commonly in the extremities. These tumors have a relatively high local failure rate after primary treatment using surgery and/or radiotherapy, and although rarely giving rise to distant metastases, can be multifocal and, therefore, not surgically resectable. Moreover, tumor may recur adjacent to the site of surgical resection, underscoring the limitations of surgery in the palliative setting. Therefore, effective medical therapies for AF are needed to maintain quality of life and prolong survival.The goal of the current study was to better define the activity of imatinib in the treatment of AF and to determine the molecular basis for response/nonresponse
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A Cohort Study of Patients Treated With Brachytherapy for Selected Desmoid Patients in Gardner Syndrome

Recruiting Status:

Completed

Last Updated:

January 31, 2011

Sponsor:

Triemli Hospital

ClinicalTrials.gov #:

NCT01286662

Genders:

Sexes Eligible for Study: All

Ages:

Child, Adult, Older Adult

Description:

The purpose of this study is to assess the long-term outcome in a cohort of Gardner-Syndrome patients receiving prophylaxis and treatment for intestinal and non-intestinal tumors .
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Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas

Recruiting Status:

Completed

Last Updated:

January 20, 2016

Sponsor:

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov #:

NCT00474994

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years to 120 Years   (Adult, Older Adult)

Description:

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor . PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic, locally advanced, or locally recurrent sarcomas.
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A Dose Escalation Study of OMP-54F28 in Subjects With Solid Tumors

Recruiting Status:

Completed

Last Updated:

July 27, 2017

Sponsor:

OncoMed Pharmaceuticals, Inc.

ClinicalTrials.gov #:

NCT01608867

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years to 90 Years   (Adult, Older Adult)

Description:

This is an open-label Phase 1 dose escalation study of OMP-54F28 in subjects with a solid tumor for which there is no remaining standard curative therapy. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed. Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive OMP-54F28 until disease progression. All subjects will receive Vitamin D3 daily and calcium carbonate twice daily from Day 0 through 30 days following the discontinuation of OMP-54F28. Dose escalation will be conducted to determine the maximum tolerated dose (MTD). Subjects will be dosed at 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks. No dose escalation or reduction will be allowed within a dose cohort. Intermediate doses (i.e., doses between the dose levels listed above) may also be tested upon agreement with the investigators and the study sp
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Studying Genes in Tissue Samples From Younger and Adolescent Patients With Soft Tissue Sarcomas

Recruiting Status:

Completed

Last Updated:

May 17, 2016

Sponsor:

Children's Oncology Group

ClinicalTrials.gov #:

NCT01567046

Genders:

Sexes Eligible for Study: All

Ages:

up to 30 Years   (Child, Adult)

Description:

This research trial studies genes in tissue samples from younger and adolescent patients with soft tissue sarcomas. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer . It may also help doctors find better ways to treat cancer
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Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain

Recruiting Status:

Completed

Last Updated:

March 5, 2014

Sponsor:

INSYS Therapeutics Inc

ClinicalTrials.gov #:

NCT00538850

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication is administered under the tongue as a simple spray and can be self-administered by patients or assisted by their caregivers. Patients are titrated to an effective-dose of fentanyl sublingual spray in the open-label titration period and then proceed to the double-blind randomized period where they randomly receive 7 treatments with fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods).
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MS-275 in Treating Patients With Advanced Solid Tumors or Lymphoma

Recruiting Status:

Completed

Last Updated:

March 15, 2012

Sponsor:

National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov #:

NCT00020579

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

RATIONALE: MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I trial is studying the side effects and best dose of MS-275 in treating patients with advanced solid tumors or lymphoma.
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Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate

Recruiting Status:

Completed

Last Updated:

June 7, 2012

Sponsor:

Centre Oscar Lambret

ClinicalTrials.gov #:

NCT01046487

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).
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Effect of Hydroxyurea as Treatment for Primary Desmoid Tumors

Recruiting Status:

Withdrawn

Last Updated:

April 20, 2017

Sponsor:

Children's Hospital of Philadelphia

ClinicalTrials.gov #:

NCT00978146

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE up to 21 Years   (Child, Adult)

Description:

The purpose of this study is to examine the response rate of desmoid tumors to hydroxyurea. The investigators hypothesize that hydroxyurea will be a safe, non-toxic alternative to aggressive surgery or chemotherapy for this difficult to treat tumor .
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A Study to Evaluate the Safety and Efficacy of Vactosertib and Imatinib in Patients With Advanced Desmoid Tumor

Recruiting Status:

Not yet recruiting

Last Updated:

March 18, 2019

Sponsor:

Yonsei University

ClinicalTrials.gov #:

NCT03802084

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 19 Years and older   (Adult, Older Adult)

Description:

This is a phase I/II, open-label, non-randomized, multicentre study to evaluate the clinical activity of vactosertib plus imatinib in desmoid tumor . Based on the background, TGF-β inhibition as a potential therapeutic target for desmoid tumor and convey significant implications for the clinical development. Therefore, investigator will conduct the phase II trial of vactosertib in combined with imatinib in desmoid tumor .
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Tailored Beta-catenin Mutational Approach in Extra-abdominal Sporadic Desmoids Tumor Patients

Recruiting Status:

Unknown status

Last Updated:

September 11, 2015

Sponsor:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

ClinicalTrials.gov #:

NCT02547831

Genders:

Sexes Eligible for Study: All

Ages:

Child, Adult, Older Adult

Description:

This is a prospective, multicenter observational study under the umbrella of the ISG (Italian Sarcoma Group) evaluating local progression-free survival at 3 years of patients affected by extra-abdominal primary fibromatosis managed with front-line conservative approach and treated only in case of demonstrated progressive disease. All patients included will be placed on wait and see approach and then shifted to treatment in case of documented radiological progressive disease. For patient primarily evaluated for suspected desmoid tumor , a core-needle biopsy (eventually under CT/ultrasound guide) will be obtained for histological diagnosis and mutational analysis of CTNNB1 exon 3 (gene encoding Beta-catenin). If incisional biopsy or surgical procedure has done elsewhere, samples will be requested for histological confirmation and mutational analysis (centralization at the investigators Institution). In case of progression at 3 months, defined as tumor growth documented radiolog
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Toremifene in Desmoid Tumor : Prospective Clinical Trial and Identification of Potential Molecular Targets

Recruiting Status:

Unknown status

Last Updated:

February 2, 2015

Sponsor:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

ClinicalTrials.gov #:

NCT02353429

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

This is a prospective study evaluating the activity and the safety of toremifene in patients with primary or recurrent sporadic DTs. Patients will be enrolled after the histological confirmation of DTs on biopsy Patients will start at 60 mg daily and dose-escalate to 180 mg upon progression. Disease assessment will be performed by contrast-enhanced MRI or CT scan, pain evaluation by a visual analog scale (VAS) every 3 months for the first and second year, twice yearly thereafter. Response will be evaluated either by RECIST and/or symptomatic relief.
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Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma

Recruiting Status:

Not yet recruiting

Last Updated:

March 25, 2019

Sponsor:

Sarcoma Oncology Research Center, LLC

ClinicalTrials.gov #:

NCT03886311

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

This is a Phase 2 study using talimogene laherparepvec, nivolumab, and trabectedin as first, second or third line therapy for advanced sarcoma, including desmoid tumor and chordoma.
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Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies

Recruiting Status:

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Last Updated:

February 1, 2019

Sponsor:

University of Colorado, Denver

ClinicalTrials.gov #:

NCT02955446

Genders:

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Ages:

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Description:

This is a single-center, open label, non randomized, compassionate use protocol in patients with advanced solid tumor malignancies who were previously enrolled in the phase I study (NCT00878189) of this agent.
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Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutation in Familial Adenomatous Polyposis-minors' Adjusted Version

Recruiting Status:

Unknown status

Last Updated:

February 3, 2015

Sponsor:

michal roll

ClinicalTrials.gov #:

NCT02354560

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 10 Years to 17 Years   (Child)

Description:

Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world with a lifetime risk of 6%. Etiology is complex, while genetic background significantly affects the risk. Around one third of all genetic disorders as well as most cases of Familial Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur as a result of premature nonsense mutations (creating a stop codon) in an individual's adenomatous polyposis coli (APC) gene. Nonsense mutations are single-point alterations in the DNA that prematurely halt the protein translation process, producing a shortened, nonfunctional protein. In many of these cases, if the cell can be 'persuaded' to ignore the premature stop codon signal, the resulting protein may be able to ameliorate or stop the disease. Recently, members of the aminoglycoside family of antibiotics have been found to induce ribosomal read-through of nonsense mutations, leading to expression of a full length, functional
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Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutations in Familial Adenomatous Polyposis

Recruiting Status:

Unknown status

Last Updated:

June 26, 2014

Sponsor:

michal roll

ClinicalTrials.gov #:

NCT02175914

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 18 Years and older   (Adult, Older Adult)

Description:

Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world with a lifetime risk of 6%. Etiology is complex, while genetic background significantly affects the risk. Around one third of all genetic disorders as well as most cases of Familial Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur as a result of premature nonsense mutations (creating a stop codon) in an individual's adenomatous polyposis coli (APC) gene. Nonsense mutations are single-point alterations in the DNA that prematurely halt the protein translation process, producing a shortened, nonfunctional protein. In many of these cases, if the cell can be 'persuaded' to ignore the premature stop codon signal, the resulting protein may be able to ameliorate or stop the disease. Recently, members of the aminoglycoside family of antibiotics have been found to induce ribosomal read-through of nonsense mutations, leading to expression of a full length, functional
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HIFU Hyperthermia With Liposomal Doxorubicin (DOXIL) for Relapsed or Refractory Pediatric and Young Adult Solid Tumors

Recruiting Status:

Withdrawn

Last Updated:

March 19, 2019

Sponsor:

Theodore Laetsch

ClinicalTrials.gov #:

NCT02557854

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 1 Year to 40 Years   (Child, Adult)

Description:

The purpose of this study is to determine whether Doxil (liposomal doxorubicin) given prior to MR-HIFU Hyperthermia is safe for the treatment of pediatric and young adult patients with recurrent and refractory solid tumors .
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Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients

Recruiting Status:

Terminated

Last Updated:

March 9, 2010

Sponsor:

Pfizer

ClinicalTrials.gov #:

NCT00151476

Genders:

Sexes Eligible for Study: All

Ages:

12 Years and older   (Child, Adult, Older Adult)

Description:

This is a registry-based observational study assessing clinical outcomes in FAP patients receiving celecoxib compared with historical/concurrent registry patients who have not received celecoxib. Both retrospective and prospective data will be utilized. No sampling methods apply.
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Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors

Recruiting Status:

Terminated

Last Updated:

May 23, 2018

Sponsor:

Pejman Ghanouni

ClinicalTrials.gov #:

NCT01965002

Genders:

Sexes Eligible for Study: All

Ages:

  ICMJE 10 Years and older   (Child, Adult, Older Adult)

Description:

The goal of this project is to evaluate the safety and preliminary efficacy of ExAblate magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) surgery in the treatment of soft tissue tumors of the extremities.
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