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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001209

Collaborator

(none)

120

Enrollment

Location

166

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroectodermal Tumor, Primitive Neuroepithelioma Osteosarcoma Sarcoma Sarcoma, Ewing's	Drug: vincristine, adriamycin and cytoxan, alternating with ifosfamide VP-16	Phase 1

Detailed Description

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 1986

Study Completion Date :

Aug 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).