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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Genetic: protein expression analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: diagnostic laboratory biomarker analysis; Drug: temozolomide; Other: immunoenzyme technique

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00498927

P30CA008748 (U.S. NIH Grant/Contract)

07-064

SPRI-PO5096

MSKCC-07064

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 47 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Temozolomide

Experimental group

Description:

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.

Treatment:

Genetic: protein expression analysis

Genetic: reverse transcriptase-polymerase chain reaction

Other: diagnostic laboratory biomarker analysis

Drug: temozolomide

Other: immunoenzyme technique