Procarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors
Intervention: isotretinoin (Drug); procarbazine hydrochloride (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: M.D. Anderson Cancer Center
Official(s) and/or principal investigator(s):
Kurt A. Jaeckle, MD, Study Chair, Affiliation: M.D. Anderson Cancer Center
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.
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 design: Treatment, Randomized
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).
Minimum age: 16 Years.
Maximum age: N/A.
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
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
Locations and Contacts
Clinical trial summary from the National Cancer Institute's PDQ® database
Last updated: May 23, 2008