Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma.
Central Nervous System Tumors
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases|
- Objective Response [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]Response will be assessed clinically, cytologically, and radiographically.
- Pharmacokinetics [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]Drug levels in cerebrospinal fluid assessed every 6 weeks
- Survival [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: Baseline, weekly during cycle 1, before each additional cycle ] [ Designated as safety issue: No ]FACT-Br
|Study Start Date:||January 2000|
|Study Completion Date:||May 2004|
|Primary Completion Date:||May 2004 (Final data collection date for primary outcome measure)|
Oral temozolomide 75 mg/m2/day for 6 weeks, followed by 4 week break. Cycles will continue until:
- Determine the objective response rate, survival time, and quality of life of patients with leptomeningeal metastases from a solid tumor or lymphoma when treated with oral temozolomide.
- Determine adverse events related to this regimen in this patient population.
- Measure temozolomide concentrations in CSF and serum and correlate with appropriate pharmacodynamic parameters (e.g., response) in these patients.
OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression.
Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients with a CR except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response.
Quality of life is assessed at baseline, weekly for the first 4 weeks of therapy, and then monthly thereafter.
PROJECTED ACCRUAL: A total of 14-24 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005812
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|Study Chair:||Thomas H. Davis, MD||Norris Cotton Cancer Center|