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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


Phase 3
16 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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).

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression for Procarbazine alone or with Isotretinoin

Outcome Description:

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

Outcome Time Frame:

Six 28-day cycles

Safety Issue:

No

Principal Investigator

Kurt A. Jaeckle, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

DM97-050

NCT ID:

NCT00003564

Start Date:

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

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