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 ]

Response will be assessed clinically, cytologically, and radiographically.


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