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

NCT00004688 | Completed Phase 2

• 2 other identifiers: 199/13310EUSM-FDR001274
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Mixed Gliomas; Glioblastoma Multiforme; Recurrent Brain Tumor

Keywords

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

Interventions

carmustine DRUG

mercaptopurine DRUG

streptozocin DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Emory University: lead

MeSH Terms

Conditions

Astrocytoma; Oligodendroglioma; Glioma; Glioblastoma; Brain Neoplasms; Genetic Diseases, Inborn; Rare Diseases

Interventions

Carmustine; Mercaptopurine; Streptozocin

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Sulfhydryl Compounds; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Mark R. Gilbert

  Emory University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: August 1, 1996
• Study Completion: July 1, 1998
• Last Updated: March 25, 2015

Record last verified: 1999-03