Clinical Trial: Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases
Brief Summary:
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.
Detailed Summary:
OBJECTIVES:
- 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.
Sponsor: Dartmouth-Hitchcock Medical Center
Current Primary Outcome: Objective Response [ Time Frame: Every 6 weeks ]
Original Primary Outcome:
Current Secondary Outcome:
- Pharmacokinetics [ Time Frame: Every 6 weeks ]Drug levels in cerebrospinal fluid assessed every 6 weeks
- Survival [ Time Frame: every 6 weeks ]
- Quality of Life [ Time Frame: Baseline, weekly during cycle 1, before each additional cycle ]FACT-Br
Original Secondary Outcome:
Information By: Dartmouth-Hitchcock Medical Center
Dates:
Date Received: June 2, 2000
Date Started: January 2000
Date Completion:
Last Updated: May 13, 2013
Last Verified: May 2013