Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
The main purpose of this study is to assess the effect of a two-week pre-surgery treatment with low-dose temozolomide (TMZ) on brain tumor methylguanine-DNA (deoxyribonucleic acid) methyltransferase (MGMT) activity in patients with gliomas.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial to Evaluate the Effect of Low Dose Temozolomide (TMZ) for 2 Weeks on Brain Tumor O-6-methylguanine-DNA Methyltransferase (MGMT) Activity in Patients With Gliomas.|
- MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery [ Time Frame: 14 days ] [ Designated as safety issue: No ]An experimental assay was developed to measure MGMT levels.
- Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Grade 3 was defined as severe per Common Terminology Criteria for Adverse Events (CTCAE).
Grade 4 was defined as life-threatening per CTCAE.
- Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]An AE was defined as any event which was adverse, including what were commonly described as adverse or undesirable experiences, adverse events, adverse reactions, side effects, or death due to any cause associated with, or observed in conjunction with the use of a drug, biological product, or device in humans, whether or not considered related to the use of that product. Additionally, any event which was associated with, or observed in conjunction with product overdose whether accidental or intentional, or product abuse and/or withdrawal was also considered an AE.
- Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor [ Time Frame: 14 days ] [ Designated as safety issue: No ]No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.
- MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels [ Time Frame: 14 days ] [ Designated as safety issue: No ]No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.
|Study Start Date:||September 2006|
|Study Completion Date:||February 2011|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
|Experimental: Temozolomide treatment||
Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
As standard of care, it could also be given at the same dose for up to 28 days after surgery, per investigator discretion.
Other Name: SCH 052365
|No Intervention: No treatment|
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