Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain and Central Nervous System Tumors

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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temozolomide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No