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

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004688
First received: February 24, 2000
Last updated: March 24, 2015
Last verified: March 1999

February 24, 2000
March 24, 2015
August 1996
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Complete list of historical versions of study NCT00004688 on ClinicalTrials.gov Archive Site
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Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms
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OBJECTIVES:

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

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.

Completion date provided represents the completion date of the grant per OOPD records

Interventional
Phase 2
Primary Purpose: Treatment
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Mixed Gliomas
  • Glioblastoma Multiforme
  • Recurrent Brain Tumor
  • Drug: carmustine
  • Drug: mercaptopurine
  • Drug: streptozocin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
July 1998
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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

Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004688
199/13310, EUSM-FDR001274
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Emory University
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Study Chair: Mark R. Gilbert Emory University
FDA Office of Orphan Products Development
March 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP