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


Phase 1
N/A
N/A
Not Enrolling
Both
Neuroectodermal Tumor, Primitive, Neuroepithelioma, Osteosarcoma, Sarcoma, Sarcoma, Ewing's

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Trial Information

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


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.

Inclusion 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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

860169

NCT ID:

NCT00001209

Start Date:

October 1986

Completion Date:

August 2000

Related Keywords:

  • Neuroectodermal Tumor, Primitive
  • Neuroepithelioma
  • Osteosarcoma
  • Sarcoma
  • Sarcoma, Ewing's
  • Combined Chemotherapy
  • Irradiation
  • Unresectable
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Osteosarcoma
  • Neuroectodermal Tumors, Primitive
  • Sarcoma, Ewing's
  • Sarcoma

Name

Location
National Cancer Institute (NCI) Bethesda, Maryland  20892