Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive malignant glioma.

Detailed Description
-----------------
OBJECTIVES: Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide. Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide. Determine the toxicity of this regimen in these patients. OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma). Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

Official Title
-----------------
A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas

Conditions
-----------------
Brain and Central Nervous System Tumors

Intervention / Treatment
-----------------
* Drug: temozolomide


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically proven recurrent or progressive malignant glioma of one of the following types: Anaplastic oligodendroglioma or oligoastrocytoma Anaplastic astrocytoma Glioblastoma multiforme (stratum closed to accrual 11/30/01) Patients who have failed radiotherapy are eligible Measurable disease by CT scan or MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 10 g/dL Hepatic: SGOT or SGPT less than 3 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed) Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No other serious concurrent infection or other medical illness that would preclude study entry No frequent vomiting or partial bowel obstruction HIV negative No AIDS-related illness No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent epoetin alfa Chemotherapy: At least 6 weeks since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator) Surgery: Recovered from prior surgery Other: No other concurrent investigational agents Concurrent anticonvulsant therapy allowed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: temozolomide|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent adult brain tumor, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma