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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003564 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: Isotretinoin Drug: Procarbazine Hydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 194 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (Procarbazine + Isotretinoin)
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.
|
Drug: Isotretinoin
Oral isotretinoin is administered every 12 hours on days 15-28 every 28 days.
Other Names:
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. |
|
Experimental: Arm II (Procarbazine Alone)
Arm II: Oral Procarbazine once daily on days 1-14 followed by 2 weeks of rest for a total of 6 courses of treatment.
|
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. |
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).
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
| Responsible Party: | Jaeckle, Kurt, M.D., UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003564 History of Changes |
| Other Study ID Numbers: | DM97-050, P30CA016672, MDA-DM-97050, NCI-T97-0078, CDR0000066630 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 27, 2010 |
| Health Authority: | United States: Federal Government |
|
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 Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Neoplasms by Site Nervous System Diseases Isotretinoin Tretinoin Procarbazine Dermatologic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Keratolytic Agents |
