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Clinical Trial: Chemotherapy in Treating Patients With Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor
This study is no longer recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| metastatic tumors of the Ewing's family | Drug: cisplatin Drug: etoposide Procedure: chemotherapy | Phase II |
MedlinePlus related topics: Bone Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Cisplatin and Etoposide in Patients With Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor
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.
Eligibility
Ages Eligible for Study: 15 Years - 65 Years, Genders Eligible for Study: Both
Criteria
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
Location Information
Ian Robert Judson, MA, MD, FRCP, Study Chair, National Cancer Research Institute (NCRI)
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: February 2003
Last Updated: October 13, 2004
Record first received: April 10, 2001
ClinicalTrials.gov Identifier: NCT00014313
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Administration for Children and Families
- After an Affair: How Marital Therapy Heals the Wounds (American Association for Marriage and Family Therapy)

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