Skip to main content
OpenTrials
Completed

NCT Number: NCT00498927

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temozolomide

Drug

protein expression analysis

Genetic

reverse transcriptase-polymerase chain reaction

Genetic

diagnostic laboratory biomarker analysis

Other

immunoenzyme technique

Other

Primary outcomes

  1. Progression-free Survival (PFS) Rate at 6 Months

    Time frame: 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.

Secondary outcomes

  1. Overall Survival

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • Schering-Plough
  • Weill Medical College of Cornell University

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2007
Registry last updated
Feb 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.