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Sarcoma, Alveolar Soft Part clinical trials

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NCT ID: NCT01391962 Active, not recruiting - Clinical trials for Sarcoma, Alveolar Soft Part

Sunitinib or Cediranib for Alveolar Soft Part Sarcoma

Start date: July 18, 2011
Phase: Phase 2
Study type: Interventional

Background: - Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor accounting for less than 1% of soft tissue sarcomas. There is no effective systemic treatment for patients with metastatic ASPS. Little is known with regards to relevant molecular markers as potential therapeutic targets. - Cediranib (AZD2171) and sunitinib (SU011248), oral small molecule inhibitors of VEGF receptor tyrosine kinases, are showing preliminary evidence of activity in patients with ASPS. Objectives: - Part I: Determine the objective response rate (ORR) of single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS. - Part II: Determine the ORR of cediranib in patients who progress on the sunitinib arm, and determine the ORR of sunitinib in patients who progress on the cediranib arm. - Determine the progression-free survival (PFS) at 24 weeks for single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS. Eligibility: - Patients aged greater than or equal to 16 years with histologically or cytologically confirmed metastatic ASPS. - Patients must show evidence of objective disease progression per RECIST 1 on scans within the 3-month period immediately preceding enrollment. Both scans used to determine disease progression should have been obtained within this 6-month period. - Patients with newly diagnosed, unresectable, measurable, metastatic ASPS who show clinical evidence of disease progression will be eligible. - Patients must not have received treatment with any VEGF receptor tyrosine kinase inhibitor (e.g., cediranib, sunitinib, pazopanib, sorafenib); however, prior treatment with bevacizumab is allowed. Design: - Part I: Patients will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day in 28-day cycles. - Part II: At the time of disease progression, patients will cross over to the other treatment arm after a 2-week wash-out period. - Appropriate anatomic imaging studies will be performed at baseline and every 2 cycles for restaging. - The study will be conducted using an optimal two-stage design to rule out an unacceptably low 15% clinical response rate (PR+CR) in favor of a modestly high response rate of 40%. The study will initially enroll 10 evaluable patients in each arm. If 0 or 1 of the 10 patients has a clinical response, then no further patients will be accrued. If 2 or more the first 10 patients have a response, then accrual continues to a total of 22 patients in each arm.

NCT ID: NCT01337401 Active, not recruiting - Clinical trials for Alveolar Soft-part Sarcoma

A Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)

CASPS
Start date: July 2011
Phase: Phase 2
Study type: Interventional

The study is a two-arm, randomised, double-blind, international, multi-centre phase II trial of cediranib in Alveolar Soft Part Sarcoma (ASPS). The study aims to confirm the ability of cediranib to halt disease progression in patients with metastatic ASPS, as measured by the change in tumour size at 24 weeks after randomisation, and to produce objective response according to RECIST criteria.

NCT ID: NCT01154452 Completed - Clinical trials for Gastrointestinal Stromal Tumor

Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma

Start date: June 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This randomized phase I/II clinical trial is studying the side effects and best dose of gamma-secretase/notch signalling pathway inhibitor RO4929097 when given together with vismodegib and to see how well they work in treating patients with advanced or metastatic sarcoma. Vismodegib may slow the growth of tumor cells. Gamma-secretase/notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vismodegib together with gamma-secretase/notch signalling pathway inhibitor RO4929097 may be an effective treatment for sarcoma.

NCT ID: NCT00942877 Active, not recruiting - Clinical trials for Sarcoma, Alveolar Soft Part

Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma

Start date: July 18, 2009
Phase: Phase 2
Study type: Interventional

Background: - Alveolar soft part sarcoma is a type of cancer that develops in tissues that connect, support, or surround other organs in the body. It relies heavily on new blood vessels to grow and spread through the body. There is no effective systemic treatment for patients with alveolar soft part sarcoma. - The drug AZD2171 (cediranib) is an experimental drug, not yet approved by the Food and Drug Administration. The drug blocks the creation of new blood vessels. The drug has had initial clinical trials, and researchers are interested in determining whether cediranib is effective in inhibiting tumor growth in individuals who have alveolar soft part sarcoma. Objectives: - To find out whether AZD2171 works in patients who have alveolar soft part sarcoma. Eligibility: - Individuals 18 years of age and older who have been diagnosed with alveolar soft part sarcoma. Design: - After an initial screening visit, patients will take AZD2171 by mouth once a day, every day for the duration of the study. The treatment will be given in 28-day cycles. - Patients will keep a study diary to record the doses taken, any missed doses, and any side effects. - Patients will have the following tests and procedures during the treatment period: clinic visit with physical examination every 2 weeks during cycles 1 and 2, then at the start of each subsequent cycle, regular blood pressure monitoring, blood and urine tests, heart function tests, imagining scans to evaluate tumor size and response to the treatment, and possible tumor biopsy.

NCT ID: NCT00557609 Completed - Clinical trials for Renal Cell Carcinoma (RCC)

Phase 2 Study in Patients With MiT Tumors

Start date: October 2007
Phase: Phase 2
Study type: Interventional

This is a multi-center, single arm intended to evaluate the anti-tumor effect of ARQ 197 in patients with microphthalmia transcription factor associated (MiT) tumors. MiT tumors include clear cell sarcoma, alveolar soft parts sarcoma, and translocation associated renal cell carcinoma.

NCT ID: NCT00464620 Completed - Rhabdomyosarcoma Clinical Trials

Trial of Dasatinib in Advanced Sarcomas

Start date: May 2007
Phase: Phase 2
Study type: Interventional

This study will examine the response rate and the 6-month progression-free survival rates of subjects with advanced sarcoma treated with dasatinib.

NCT ID: NCT00401388 Completed - Chondrosarcomas Clinical Trials

A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

Start date: November 2006
Phase: Phase 2
Study type: Interventional

This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg orally qhs with food until disease progression. The goals of this study include: - In this study a daily dose of perifosine previously determined to be relatively non-toxic will be evaluated in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. - Response to therapy will be based on regression of measurable disease according to Choi criteria. Time to progression and duration of stable disease will be measured as secondary endpoints of the study.

NCT ID: NCT00346164 Completed - Clinical trials for Stage IV Adult Soft Tissue Sarcoma

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

Start date: February 5, 2007
Phase: Phase 3
Study type: Interventional

This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

NCT ID: NCT00340353 Completed - Sarcoma Clinical Trials

Collection of Alveolar Soft Part Sarcoma and Blood Specimens for Research

Start date: April 7, 2005
Phase: N/A
Study type: Observational

Background: Alveolar soft part sarcoma (ASPS) is a rare tumor. ASPS is resistant to chemotherapy and radiation. ASPS is characterized by slow growth. Currently no in vitro or in vivo models of ASPS exist for use in experimental therapeutic studies or biological investigations. Primary Objectives: Acquisition of blood and tissue from patients with ASPS. Acquisition of blood from healthy controls for comparison with blood from patients with ASPS. These control samples will be obtained from study NCI at Frederick Protocol OH99-C-N046. Eligibility: Subjects of any age with a diagnosis of primary or metastatic alveolar soft part sarcoma who are undergoing medically indicated surgery for their disease. Design: Patients with Alveolar Soft Part Sarcoma (ASPS) will be eligible for this study. Biopsy tissue will be obtained as an additional sample at the time of a medically indicated procedure. Blood sample may be collected at initial visit and follow-up visits. Specific risks will be described in a separate consent to be obtained at the time of the biopsy. Tumor samples and blood samples will be processed and/or stored for use in research efforts in the laboratory of Dr. David Vistica, National Cancer Institute, Frederick, MD. Additionally, blood samples will be obtained from healthy volunteers for comparison to patients with ASPS. These control samples will be obtained from the National Cancer Institute at Frederick Protocol OH99-C-N046.

NCT ID: NCT00258687 Completed - Melanoma Clinical Trials

Vaccine Trial for Clear Cell Sarcoma, Pediatric Renal Cell Carcinoma, Alveolar Soft Part Sarcoma and Children With Stage IV Melanoma

Start date: January 2005
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn if a vaccine made from the patient's own tumor cells, then genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), will delay or stop the growth of the tumor. It will also look at the vaccine's effects on the immune system and the side effects of giving a vaccine made from a subject's own cancer cells.