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

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


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

Condition Intervention Phase
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Mixed Gliomas
Glioblastoma Multiforme
Recurrent Brain Tumor
Drug: carmustine
Drug: mercaptopurine
Drug: streptozocin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 35
Study Start Date: August 1996
Estimated Study Completion Date: July 1998
Detailed Description:


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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


--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

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Please refer to this study by its identifier: NCT00004688

Sponsors and Collaborators
Emory University
Study Chair: Mark R. Gilbert Emory University
  More Information

No publications provided Identifier: NCT00004688     History of Changes
Other Study ID Numbers: 199/13310, EUSM-FDR001274
Study First Received: February 24, 2000
Last Updated: March 24, 2015
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult brain stem glioma
adult brain tumor
adult glioblastoma multiforme
adult infiltrating astrocytoma
brain tumor
genetic condition
miscellaneous sites/terms
mixed gliomas
nervous tissue tumors
oncologic disorders
rare disease
recurrent adult brain tumor

Additional relevant MeSH terms:
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents processed this record on November 27, 2015