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Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms - Article


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Streptozocin

Zanosar


Clinical Trial: Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms

This study is no longer recruiting patients.

Sponsors and Collaborators: FDA Office of Orphan Products Development
Emory University
Information provided by: FDA Office of Orphan Products Development

Purpose

OBJECTIVES: I. Assess the clinical response of patients with refractory or recurrent brain neoplasms treated with carmustine, streptozocin, and mercaptopurine.

Condition Treatment or Intervention Phase
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Mixed Gliomas
Glioblastoma Multiforme
Recurrent Brain Tumor
 Drug: carmustine
 Drug: mercaptopurine
 Drug: streptozocin
Phase II

MedlinePlus related topics:  Brain Cancer;   Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Treatment

Further Study Details: 

Expected Total Enrollment:  35

Study start: August 1996

PROTOCOL OUTLINE: Patients receive mercaptopurine IV on days 1-3, carmustine by continuous infusion on days 3-5, and streptozocin IV over 20 minutes on days 2-5. Patients receive treatment every 42 days, for up to 4 courses.

Eligibility

Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven refractory or recurrent brain neoplasms Glioblastoma multiforme Anaplastic astrocytoma Gliosarcoma Anaplastic oligodendroglioma Mixed anaplastic glioma Unequivocally progressive primary brainstem tumors following primary therapy Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy At least 6 weeks since prior nitrosoureas or mitomycin Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Prior surgery allowed --Patient Characteristics-- Age: Not specified Performance status: ECOG 0-2 Karnofsky 60-100% Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 4 times normal Renal: Creatinine no greater than 2.0 mg/dL Pulmonary: FEV1 greater than 1 L if symptomatic pulmonary disease present Other: No other concurrent malignancies Not pregnant or lactating Negative pregnancy test Fertile patients must use effective contraception

Location Information

Study chairs or principal investigators

Mark R. Gilbert,  Study Chair,  Emory University   

More Information

Study ID Numbers:  199/13310; EUSM-FDR001274
Record last reviewed:  March 1999
Last Updated:  October 13, 2004
Record first received:  February 24, 2000
ClinicalTrials.gov Identifier:  NCT00004688
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 16, 2008



Page Updated: June 1, 2005
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