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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498927
• Other study ID #: 07-064
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: Phase 2
• First received: July 10, 2007
• Last updated: February 1, 2016
• Start date: June 2007
• Est. completion date: December 2013

Study information

• Verified date: February 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• temozolomide

Genetic:
• protein expression analysis

• reverse transcriptase-polymerase chain reaction

Other:
• diagnostic laboratory biomarker analysis

• immunoenzyme technique

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI), Schering-Plough, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) Rate at 6 Months	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	at 6 months	No
Secondary	Overall Survival	All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response.	2 years	No