Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2013-12-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma.

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Detailed Description

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OBJECTIVES:

Primary

* Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide.

Secondary

* Determine the overall survival of patients treated with this drug.

OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis. Samples are analyzed by protein expression, reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected and tested as of 1/12/09)

Conditions

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Brain and Central Nervous System Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Temozolomide

Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.

Group Type EXPERIMENTAL

temozolomide

Intervention Type DRUG

protein expression analysis

Intervention Type GENETIC

reverse transcriptase-polymerase chain reaction

Intervention Type GENETIC

diagnostic laboratory biomarker analysis

Intervention Type OTHER

immunoenzyme technique

Intervention Type OTHER

Interventions

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temozolomide

Intervention Type DRUG

protein expression analysis

Intervention Type GENETIC

reverse transcriptase-polymerase chain reaction

Intervention Type GENETIC

diagnostic laboratory biomarker analysis

Intervention Type OTHER

immunoenzyme technique

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Pathologically diagnosed glioblastoma multiforme or other malignant glioma

* Recurrent disease
* Must have received prior temozolomide

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* Granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* SGOT ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 2 times ULN
* Bilirubin ≤ 2 times ULN
* No other active malignancy except for cervical carcinoma in situ or basal cell carcinoma of the skin
* No serious medical or psychiatric illness that, in the opinion of the investigator, would preclude study treatment
* No medical condition that precludes swallowing pills
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Recovered from all prior therapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No