Chemotherapy in Treating Patients With Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic Ewing's sarcoma or primitive neuroectodermal tumor.

Detailed Description
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OBJECTIVES: Determine the activity of cisplatin and etoposide in terms of response of patients with metastatic Ewing's sarcoma or primitive neuroectodermal tumor. Assess the bone marrow and kidney toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive cisplatin IV over 3 hours on days 1, 8, 15, 29, 36, and 43 and oral etoposide daily on days 1-15 and 29-43 in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 2 years.

Official Title
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A Phase II Study to Evaluate the Role of Weekly Cisplatin With Oral Etoposide in Ewing's Sarcoma and Primitive Neuroectodermal Tumor (PNET) With Bone and/or Bone Marrow Metatstatic Disease

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: cisplatin
* Drug: etoposide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed Ewing's family tumor as characterized by the following: Positive MIC2 on immunohistochemistry OR Evidence of a chromosomal translocation involving the EWS gene by conventional cytogenetics t(11; 22) translocation or variant OR Demonstration of EWS/FLI1 or EWS/ERG gene fusion by PCR or FISH Metastases outside the lung or pleura At least 1 measurable lesion outside of previously irradiated area No symptomatic or known CNS metastases PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 mg/dL Albumin greater than 2.5 g/dL Renal: Creatinine less than 1.2 mg/dL Creatinine clearance greater than 70 mL/min Cardiovascular: No history of uncontrolled cardiovascular disease Other: No other severe medical illness, including psychosis No other prior primary malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: etoposide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor