A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases
18 Years
N/A
Both
Brain Tumors, Central Nervous System Tumors, Leptomeningeal Metastases
Trial Information
A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases
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.
Inclusion Criteria
- Documented leptomeningeal metastases
- Carcinomatous meningitis that is previously untreated or failed prior therapy OR
- Lymphomatous meningitis
- Systemic disease that is responding or stable on current therapy not eligible if
discontinuing therapy would be deleterious
- Age 18 and over
- Karnofsky Performance Status 60-100%
- Life expectancy of at least 6 weeks
- Absolute neutrophil count greater than 1,500/μL
- Platelet count greater than 100,000/μL
- Creatinine no greater than 2.0 mg/dL
- No congestive heart failure
- No unstable angina
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No contraindication to diagnostic sampling of CSF via lumbar puncture or reservoir
- No medical conditions that would interfere with absorption of oral medication (e.g.,
malabsorption, obstruction, or frequent vomiting)
- No uncontrolled infection
- Prior neuroaxis chemotherapy (lumbar puncture, reservoir, or systemic) allowed
- No other concurrent chemotherapy for other sites of disease
- No prior radiotherapy to areas of measurable meningeal disease unless there is clear
radiographic progression in these areas
- No prior radiotherapy to greater than 30% of bone marrow
- Prior radiotherapy to the neuroaxis allowed
- No concurrent radiotherapy for other sites of disease or for progressive disease
- Recovered from any prior recent therapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective Response
Outcome Description:
Response will be assessed clinically, cytologically, and radiographically.
Outcome Time Frame:
Every 6 weeks
Safety Issue:
No
Principal Investigator
Thomas H. Davis, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Norris Cotton Cancer Center
Authority:
United States: Data and Safety Monitoring Board
Study ID:
D9812
NCT ID:
NCT00005812
Start Date:
January 2000
Completion Date:
May 2004
Related Keywords:
- Brain Tumors
- Central Nervous System Tumors
- Leptomeningeal Metastases
- leptomeningeal metastases
- temozolomide
- Brain Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Meningeal Carcinomatosis
Name | Location |
|---|---|
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
