Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms
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ClinicalTrials.gov Identifier: NCT00004688 |
Recruitment Status :
Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
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OBJECTIVES:
I. Assess the clinical response of patients with refractory or recurrent brain neoplasms treated with carmustine, streptozocin, and mercaptopurine.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anaplastic Astrocytoma Anaplastic Oligodendroglioma Mixed Gliomas Glioblastoma Multiforme Recurrent Brain Tumor | Drug: carmustine Drug: mercaptopurine Drug: streptozocin | Phase 2 |
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
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 35 participants |
Primary Purpose: | Treatment |
Study Start Date : | August 1996 |
Study Completion Date : | July 1998 |


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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004688
Study Chair: | Mark R. Gilbert | Emory University |
ClinicalTrials.gov Identifier: | NCT00004688 |
Other Study ID Numbers: |
199/13310 EUSM-FDR001274 |
First Posted: | February 25, 2000 Key Record Dates |
Last Update Posted: | March 25, 2015 |
Last Verified: | March 1999 |
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 |
Glioblastoma Glioma Brain Neoplasms Astrocytoma Oligodendroglioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Mercaptopurine Carmustine Streptozocin Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |