View clinical trials related to Sarcoma.
Filter by:The purpose of this research study is to determine the safety of the combination of RAD001 and CP-751,871, as well as the highest dose of this combination that can be given to people safely. RAD001 is a newly discovered drug that may stop cancer cells from growing abnormally. This drug has been extensively studied in many cancers. In particular, it has shown to be effective in slowing down the growth of kidney cancer. CP-751,871 is another newly discovered drug that may stop tumor growth. It is currently being studied in a wide variety of cancers, and information from those other research studies suggests that these two drugs in combination may help to stop cancer growth.
Background: - The drug liposomal doxorubicin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of Kaposi's sarcoma (KS). A second drug, bevacizumab, is a biologic agent (such as antibodies, interleukins, and vaccines) that stops abnormal blood supply to tumors. Bevacizumab is approved by the FDA, in combination with other drugs, for the treatment of breast cancer, colon cancer, and lung cancer. - Researchers are now studying the combination of liposomal doxorubicin with bevacizumab as a novel approach to the treatment of advanced KS. Researches will be measuring KS tumor responses to this combination to determine whether the drugs might have anti-KS activity. Objectives: - To estimate the overall response rate (ORR) of six cycles of liposomal doxorubicin combined with bevacizumab in patients with advanced KS. - To evaluate the safety of the regimen and to estimate the complete response rate after six cycles, the median number of cycles needed to obtain a partial response, and the 12-month progression-free survival. Eligibility: - Patients 18 years or older with relatively severe acquired immune deficiency syndrome (AIDS)-related KS or patients with KS unrelated to AIDS or human immunodeficiency virus (HIV) infection, whose KS that can be evaluated for potential response to therapy and meet a number of other criteria. - Women who are pregnant or breastfeeding are not eligible. - Other ineligibility criteria include surgery within 4 weeks, chemotherapy within 3 weeks, heart disease, hemoptysis (coughing up blood), or gastrointestinal bleeding. Design: - Researchers will conduct the following tests before the start of the study: - Physical examination and a detailed medical history. - A biopsy. - Blood and urine tests. - Treatment will include two phases, an induction phase and a maintenance phase: - Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles. - Monitoring will include a review of side effects, physical exam (including blood pressure), and blood and urine samples; following the induction phase, the patient will receive a multi gated acquisition scan and electrocardiography (EKG) to record electrical activity in the heart. - Research tests include blood and saliva samples, additional biopsies (optional), and noninvasive imaging. - Treatment is stopped if any of the following occur: completion of 1 year of therapy, progressive KS, patient preference, or unacceptable toxicity. - Post-treatment evaluations include clinic visits every 3 months or as needed up to 2 years, and blood and saliva samples (for research).
Background: - Informed consent is the process by which prospective participants in clinical trials learn about clinical research in order to decide whether they want to enroll in the study. It consists of meetings and discussions with the health care team. - Phase I clinical trials are designed to determine what dose of an investigational agent is safe to administer to patients. Objectives: - To study communication, comprehension and decision-making during the informed consent process. - To examine ethical, psychological, social, and educational issues regarding informed consent. - To help researchers understand how to improve informed consent and education about clinical research. Eligibility: - Parents or guardians of children with cancer who are being considered for participation in phase I clinical trials - Prospective patients for pediatric phase I clinical trials who are between 14 and 21 years of age. - Members of the research team who obtain consent from patients and families for pediatric phase I clinical trials Design: - Research assistants observe and record the informed consent conference held with the research team and the parents and children. - After the conference, the research assistant interviews the parents in a private area about their experience during the conference and their decision-making process. They are asked about their thoughts and opinions during the informed consent conference, including the decision-making process, communication and trust in the medical team. - With their parent's permission, patients are interviewed privately to discuss their experience during the informed consent conference. - After parents and patients have made their decision about participation in the study, they are interviewed again about how they made the decision, aspects of the communication during the conference, and how they feel about the doctor. This interview is also recorded. - Parents may be contacted 6 months to 2 years from the time of their participation to be part of a parent advisory group about the informed consent process.
Background: - Pediatric solid tumors (Ewing's sarcoma, rhabdomyosarcoma, and neuroblastoma) are often difficult to cure with standard treatment. - Immune therapy using an experimental vaccine made from proteins from the patient's tumor cells may boost the body's immune response against the tumor. - The effects of chemotherapy on the immune system can potentially make immunotherapy more effective if administered soon after completion of chemotherapy. The addition of recombinant human IL-7 (interleukin 7) (rhIL-7 (recombinant human interleukin 7)) may make the immunotherapy more effective. Objectives: -To determine whether immune therapy given after immune suppression can help the body fight the tumor and to determine the safety of the treatment. Eligibility: -Patients with solid tumors, i.e., Ewing's sarcoma, rhabdomyosarcoma or neuroblastoma whose disease has recurred after treatment or spread beyond the original site Design: - Patients undergo tumor biopsy (removal of a piece of tumor tissue) to collect tumor cells for making a vaccine from proteins in the patient's tumor and apheresis (removal of a quantity of white blood cells) to collect white cells for re-building the immune system after immune therapy. Apheresis is repeated three times during immunotherapy (weeks 8, 14 and 20). - After receiving standard chemotherapy for their tumor (and an additional course of fludarabine and cyclophosphamide to further suppress immunity if needed) patients receive immune therapy in Cohorts A and B. rhIL-7 is given 48 hours before the vaccine, as an injection under the skin in an extremity that will not be used for the vaccine in patients in Cohort B only. You will be watched closely for 6 hours after the rhIL-7 for any signs of reaction. rhIL-7 will be given before vaccine doses #1, #2, #3, and #4. The vaccine is given at study weeks 2, 4, 6, 8, 10 and 12. Each vaccine is given as a total of six separate rhIL-7 followed by injections: three intradermal (like a (tuberculosis) TB test) on one arm or leg and three subcutaneous (like those for insulin injections for diabetes). on the other arm or leg. An anesthetic cream may be used to minimize the discomfort of injections. - Patients' white cells are returned to them by infusion through a vein on the first day of immune therapy. - Imaging studies and immune studies are done at weeks 1, 8 and 20 to determine the response to treatment on the tumor and on the immune system.
Background: - This study is a companion biology study to NIH protocol 08-C-0080, A Phase II Trial of R1507, a Recombinant Human Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Patients with Recurrent or Refractory Ewing s Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas. - Analysis of tumor tissue and blood samples from patients with sarcomas who are receiving treatment with the experimental drug R1507 may help elucidate the biology of sarcomas and how they respond to certain therapies with monoclonal antibodies. Objectives: - To study the effect over time of R1507 on the proteins and cells in the blood and tissue of patients with sarcoma in order to learn more about how patients respond to the treatment and what changes occur in their cells. - To discover possible new treatments for cancer. Eligibility: - Participants in NIH protocol 08-C-0080 for the study of R1507 to treat people with various sarcomas. Design: - Patients who previously agreed as part of protocol 08-C-0800 to have blood sampling for pharmacodynamic studies (blood draws to test blood for levels of R1507 and how the body affects R1507) will not have any additional blood drawn as part of this study. - Patients who did not previously agree to pharmacodynamic sampling as part of the protocol 08-C-0800 will be asked to give 6 blood samples at various time periods during the study. - Pathology slides or tissue blocks obtained under protocol 08-C-0800 will be forwarded to F. Hoffmann-La Roche laboratories for analysis.
RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood cancer may help doctors learn more about the disease. PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer and in their healthy sisters and brothers.
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.
Primary objective of the study is to investigate the efficacy of vorinostat in patients suffering from selected histological types of soft tissue sarcoma. Further evaluations relate to the safety and tolerability of vorinostat, its pharmacokinetics (course of plasma concentration over time) and pharmacodynamics (mode of action). Only subjects with advanced, metastatic disease will be included in this trail.
Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection. Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET acquisitions, and tumors demonstrate detectable levels of 18F uptake on PET.
RATIONALE: 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. PURPOSE: This research study is looking at tumor tissue samples from patients with soft tissue sarcoma.