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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 (NCT00003564)

National Cancer Institute (NCI)
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.
  • Drug: Isotretinoin
    Oral isotretinoin is administered every 12 hours on days 15-28 every 28 days.
    • Accutane
    • 13-cis-retinoic acid
  • Drug: Procarbazine Hydrochloride
    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.
    Ages eligible for Study
    16 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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).
    Status:
    withdrawn
    Type:
    Interventional
    Phase:
    Start:
    01 January, 0001
    Updated:
    16 February, 2012
    Participants:
    0
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