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A Pilot Study for the Treatment of Patients with Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Pilot Study for the Treatment of Patients with Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Pilot Study for the Treatment of Patients with Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors Clinical research trials and A Pilot Study for the Treatment of Patients with Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Pilot Study for the Treatment of Patients with Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors. A Pilot Study for the Treatment of Patients with Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Pilot Study for the Treatment of Patients with Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors clinical trial. Participants frequently get the best healthcare available for their A Pilot Study for the Treatment of Patients with Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.

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A Pilot Study for the Treatment of Patients with Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors



A Pilot Study for the Treatment of Patients with Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors

For Condition: Neuroectodermal Tumor, Primitive,Neuroepithelioma,Osteosarcoma,Sarcoma,Sarcoma, Ewing's
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but will be comparable to the large data base of similar patients treated on successive Pediatric Branch studies.
Details: This protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but will be comparable to the large data base of similar patients treated on successive Pediatric Branch studies.
Eligibility:
Study Type:
  Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients with high grade soft tissue sarcomas and either metastatic disease or stage III tumors including synovial sarcoma, malignant fibrous histiocytoma, hemangiopericytoma, malignant schwannoma (neurofibrosarcoma). Patients must not have been previously treated with chemotherapy or radiation therapy. The patients age must be less than or equal to 25 years. The patient (or their guardian if under 18 years of age) must sign a document indicating that he/she is aware of the investigational nature of this treatment protocol and the potential risks and benefits that may be expected. Patients must have a direct bilirubin of less than 4.0 mg/dl. Patients must not have abnormal cardiac function (ejection fraction greater than 45% on MUGA scan with confirmation of shortening-fraction greater than 25% on echocardiography).
Total Enrollment: 120

Location and Contact Information:

National Cancer Institute (NCI)
Bethesda,  Maryland,  20892
United States
 


Additional Information:
Study ID Numbers:
  860169;  86-C-0169
Study Start Date: October 6, 1986
Record last reviewed: September 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001209

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