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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 1

Conditions: Osteosarcoma; Sarcoma; Sarcoma, Ewing's; Neuroepithelioma; Neuroectodermal Tumor, Primitive

Treatments: Drug: vincristine, adriamycin and cytoxan, alternating with ifosfamide VP-16

Study type: Interventional

Funder types: NIH

Identifiers

NCT00001209

86-C-0169

860169

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).