Sarcoma Clinical Trials

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  • Surgery With or Without Radiation Therapy in Treating Patients With Previously Untreated Nonmetastatic Retroperitoneal Soft Tissue Sarcoma
  • RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.
  • Diagnoses: Sarcoma
  • Status: Recruiting
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  • Sunitinib or Cediranib for Alveolar Soft Part Sarcoma
  • Background: - Alveolar soft part sarcoma is a rare type of tumor that has a lot of blood vessel growth. Cediranib and sunitinib are two cancer treatment drugs that work by blocking the growth of new blood vessels. This may help to stop tumor growth. Some patients with alveolar soft part sarcoma treated with cediranib or sunitinib had tumors that either decreased in size or remained stable without growth for a long time. More research is needed to see whether these drugs can be approved as a standard treatment for alveolar soft part sarcoma. Objectives: - To test the safety and effectiveness of cediranib and sunitinib to treat alveolar soft part sarcoma. - To determine the objective response rate of cediranib and sunitinib in patients with alveolar soft part sarcoma. Eligibility: - Individuals at least 16 years of age who have alveolar soft part sarcoma. - Individuals who have not received prior cediranib or sunitinib. Design: - All participants will be screened with a physical exam and medical history. They will also have blood and urine tests, tumor imaging studies, and biopsies. - Participants will be divided into two groups: one group will start with cediranib and the other will start with sunitinib. - During Part I of the study, participants will take cediranib or sunitinib by mouth once a day. They will continue this routine every day for 28 days (one cycle of treatment). They will stop taking the drug if the side effects become too severe or the tumor starts growing again. - Participants will not have any cancer treatment for 2 weeks before starting Part II. - During Part II, participants will receive the other study drug (cediranib or sunitinib). However, if one of the drugs is not effective or its side effects are too severe, participants will not receive the drug and will stop being in the study. - Participants will be monitored with frequent blood and urine tests. They will also have tumor imaging studies and other tests.
  • Diagnoses: Pediatric Sarcoma, Sarcoma
  • Status: Recruiting
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  • A Blanket Protocol to Study Oral Regorafenib in Patients With Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing-like Sarcomas
  • Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma. Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents.
  • Diagnoses: Sarcoma
  • Status: Recruiting
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  • Proton or Photon RT for Retroperitoneal Sarcomas
  • This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it. Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, or have pre-operative radiation followed by surgery. When conventional radiation therapy is delivered after surgery, it can damage normal tissue. In this study, you will undergo proton beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor. Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Since proton radiation is more targeted, it may help to reduce unwanted side effects from radiation. In this study, a standard dose of radiation will be given to the majority of the tumor, while a simultaneously integrated boost of additional radiation will be given to certain areas of the tumor identified as higher risk. This means that a higher radiation dose will be given to the higher risk areas of the tumor. The purpose of this study is to determine the highest dose of radiation therapy with protons or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the effectiveness of proton beam radiation therapy as an intervention for patients with retroperitoneal sarcomas.
  • Diagnoses: Sarcoma
  • Status: Recruiting
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  • Phase I Study of Olaprib and Temozolomide for Ewings Sarcoma
  • This research study is a Phase I clinical trial, which tests the safety of an investigational drug or combination of drugs and also tries to define the appropriate dose of the combination of investigational drugs to use for further studies. "Investigational" means that the combination of drugs is being studied. It also means that the FDA has not yet approved the combination of drugs for your type of cancer. Olaparib works by blocking the activity of a protein called poly (ADP-ribose) polymerase (PARP) which is involved in DNA repair. Cancer cells rely on PARP to repair their DNA and enable them to continue dividing. Olaparib has been used in research studies with other cancers. Information from those other research studies suggests that this drug may help to treat patients with Ewing's sarcoma. The investigational drug olaparib is not approved for any use outside of research studies. Temozolomide (Temodar) is approved by the FDA for the treatment of a type of brain tumor, glioblastoma. It has been studied in Ewing sarcoma in previous research studies. While it is not approved by the FDA for Ewing sarcoma, it is considered part of standard treatment for relapsed disease. Laboratory studies suggest that the combination of olaparib and temozolomide may help kill Ewing sarcoma cells. In this research study, the investigators are looking for the highest dose of the combination of olaparib and temozolomide that can be given safely. The investigators will also begin to collect information about the effects of the combination on Ewing sarcoma.
  • Diagnoses: Sarcoma
  • Status: Recruiting
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  • A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors
  • This is a first in human phase I study of single agent CGM097 in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. The tumor must be characterized by p53wt status. The study consists of a dose escalation part where patients will receive escalating doses of CGM097, and a dose expansion part in which patients are given CGM097 at the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Each dose escalation step will be decided based on the recommendation from an adaptive Bayesian logistic regression model (BLRM).
  • Diagnoses: Sarcoma
  • Status: Recruiting
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  • Phase 1 Safety Testing of SAR405838
  • Primary Objectives: - To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs). - To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion. Secondary Objectives: - Pharmacokinetic (PK) profile of SAR405838. - Biomarkers in association with SAR405838. - Anti-tumor activity in response to SAR405838. - Food effect on SAR405838 PK.
  • Diagnoses: Sarcoma
  • Status: Recruiting
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