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

History of Changes

Purpose

OBJECTIVES:

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:

MedlinePlus related topics: Brain Tumors

Drug Information available for: Mercaptopurine Carmustine Streptozocin

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Oligodendroglioma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Brain Tumor, Adult Neuroepithelioma

U.S. FDA Resources

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:

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

Eligibility


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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004688

Sponsors and Collaborators

Emory University

Investigators


Study Chair:	Mark R. Gilbert	Emory University

More Information


ClinicalTrials.gov Identifier:	NCT00004688 History of Changes
Other Study ID Numbers:	199/13310 EUSM-FDR001274
Study First Received:	February 24, 2000
Last Updated:	March 24, 2015

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:


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 6-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

ClinicalTrials.gov processed this record on June 22, 2017

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