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Procarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas

Primary Purpose

Brain and Central Nervous System Tumors

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Isotretinoin
Procarbazine Hydrochloride
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven primary malignant gliomas including the following: Glioblastoma multiforme Gliosarcoma Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic infiltrating glioma Mixed malignant gliomas Must show evidence of tumor recurrence or progression on at least 2 serial enhanced MRI scans Must have measurably enhancing residual disease on MRI or CT scan of brain PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 8 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGPT less than 2 times institutional normal Alkaline phosphatase less than 2 times institutional normal Bilirubin less than 1.5 mg/dL Renal: BUN less than 1.5 times institutional normal OR Creatinine less than 1.5 times institutional normal Other: No active infection Not pregnant or nursing Fertile patients must use effective contraception 1 month before, during, and 1 month after study No other disease that will obscure toxicity or alter drug metabolism No other concurrent medical illness PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior procarbazine No prior isotretinoin At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified Other: No concurrent tetracyclines

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm I (Procarbazine + Isotretinoin)

    Arm II (Procarbazine Alone)

    Arm Description

    Arm I: Oral procarbazine once daily on days 1-14 every 28 days, and Oral isotretinoin every 12 hours on days 15-28 every 28 days; 6 courses of combined therapy, then continue oral isotretinoin alone on days 15-28 of each 28 day course.

    Arm II: Oral Procarbazine once daily on days 1-14 followed by 2 weeks of rest for a total of 6 courses of treatment.

    Outcomes

    Primary Outcome Measures

    Time to Progression for Procarbazine alone or with Isotretinoin
    Effectiveness of procarbazine alone or with isotretinoin in treating patients with recurrent primary malignant gliomas measuring time to disease progression (in days).

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 1999
    Last Updated
    February 17, 2012
    Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00003564
    Brief Title
    Procarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas
    Official Title
    Phase III Randomized Evaluation of 13-Cis-Retinoic Acid (cRA) Plus Procarbazine Versus Procarbazine Alone in the Treatment of Patients With Recurrent Primary Malignant Gliomas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study withdrawn.
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether giving procarbazine alone or with isotretinoin is more effective for recurrent primary malignant glioma. PURPOSE: Randomized phase III trial to compare the effectiveness of procarbazine alone or with isotretinoin in treating patients with recurrent primary malignant gliomas.
    Detailed Description
    OBJECTIVES: I. Determine whether the combination of isotretinoin and procarbazine can improve time to progression and survival compared to procarbazine alone in patients with recurrent malignant gliomas. II. Document the toxicity of these two regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive procarbazine alone or in combination with isotretinoin. Arm I: Patients receive oral procarbazine once daily on days 1-14 every 28 days. Oral isotretinoin is administered every 12 hours on days 15-28 every 28 days. Patient receive 6 courses of combined therapy, then continue with oral isotretinoin alone on days 15-28 of each 28 day course, until disease progression or unacceptable toxicity. Arm II: Patients receive procarbazine by mouth once daily on days 1-14 followed by 2 weeks of rest. Patients receive a total of 6 courses of treatment in the absence of disease progression and unacceptable toxicity. Patients are followed until death. PROJECTED ACCRUAL: This study will accrue a total of 194 patients (97 per treatment group).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain and Central Nervous System Tumors
    Keywords
    recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I (Procarbazine + Isotretinoin)
    Arm Type
    Experimental
    Arm Description
    Arm I: Oral procarbazine once daily on days 1-14 every 28 days, and Oral isotretinoin every 12 hours on days 15-28 every 28 days; 6 courses of combined therapy, then continue oral isotretinoin alone on days 15-28 of each 28 day course.
    Arm Title
    Arm II (Procarbazine Alone)
    Arm Type
    Experimental
    Arm Description
    Arm II: Oral Procarbazine once daily on days 1-14 followed by 2 weeks of rest for a total of 6 courses of treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Isotretinoin
    Other Intervention Name(s)
    Accutane, 13-cis-retinoic acid
    Intervention Description
    Oral isotretinoin is administered every 12 hours on days 15-28 every 28 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Procarbazine Hydrochloride
    Intervention Description
    Arm I: Oral procarbazine once daily on days 1-14 every 28 days for 6 courses of combined therapy. Arm II: Oral procarbazine once daily on days 1-14 followed by 2 weeks of rest for a total of 6 courses.
    Primary Outcome Measure Information:
    Title
    Time to Progression for Procarbazine alone or with Isotretinoin
    Description
    Effectiveness of procarbazine alone or with isotretinoin in treating patients with recurrent primary malignant gliomas measuring time to disease progression (in days).
    Time Frame
    Six 28-day cycles

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically proven primary malignant gliomas including the following: Glioblastoma multiforme Gliosarcoma Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic infiltrating glioma Mixed malignant gliomas Must show evidence of tumor recurrence or progression on at least 2 serial enhanced MRI scans Must have measurably enhancing residual disease on MRI or CT scan of brain PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 8 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGPT less than 2 times institutional normal Alkaline phosphatase less than 2 times institutional normal Bilirubin less than 1.5 mg/dL Renal: BUN less than 1.5 times institutional normal OR Creatinine less than 1.5 times institutional normal Other: No active infection Not pregnant or nursing Fertile patients must use effective contraception 1 month before, during, and 1 month after study No other disease that will obscure toxicity or alter drug metabolism No other concurrent medical illness PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior procarbazine No prior isotretinoin At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified Other: No concurrent tetracyclines
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kurt A. Jaeckle, MD
    Organizational Affiliation
    M.D. Anderson Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Links:
    URL
    http://www.mdanderson.org
    Description
    UT MD Anderson Cancer Center Website

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    Procarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas

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