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



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

For Condition: Mixed Gliomas,Anaplastic Astrocytoma,Recurrent Brain Tumor,Anaplastic Oligodendroglioma,Glioblastoma Multiforme
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , Emory University
Synopsis: OBJECTIVES: I. Assess the clinical response of patients with refractory or recurrent brain neoplasms treated with carmustine, streptozocin, and mercaptopurine.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 35

Location and Contact Information:

Overall Study Official:
MarkGilbert,  Study Chair,  Emory University


Additional Information:
Study ID Numbers:
  199/13310;  EUSM-FDR001274
Study Start Date: August 1996
Record last reviewed: March 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004688

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4. Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms

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