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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

Other Neuroepithelioma Studies:
1. Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity

2. Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer

3. Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors

4. A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy

5. Phase II Trial of Gleevec (STI571) in Patients with Advanced Soft Tissue or Bone Cancer

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