Memorial Sloan-Kettering Cancer Center
New York, 10065, United States
NCT Number: NCT00498927
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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Notify Me18 year–120 year
All sexes
Interventional
Phase 2
New York, 10065, United States
OBJECTIVES:
Primary
Secondary
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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.
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.
Memorial Sloan Kettering Cancer Center
Other
A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma
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.
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