Trials / Terminated
TerminatedNCT00005812
Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Dartmouth-Hitchcock Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | temozolomide |
Timeline
- Start date
- 2000-01-01
- Primary completion
- 2004-05-01
- Completion
- 2004-05-01
- First posted
- 2003-01-27
- Last updated
- 2013-05-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00005812. Inclusion in this directory is not an endorsement.