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

Primary Purpose

Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Mixed Gliomas

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
carmustine
mercaptopurine
streptozocin
Sponsored by
Emory University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Astrocytoma focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    March 24, 2015
    Sponsor
    Emory University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004688
    Brief Title
    Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 1999
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 1998 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Emory University

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    35 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    carmustine
    Intervention Type
    Drug
    Intervention Name(s)
    mercaptopurine
    Intervention Type
    Drug
    Intervention Name(s)
    streptozocin

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark R. Gilbert
    Organizational Affiliation
    Emory University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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