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A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases

Phase 2
18 Years
Not Enrolling
Brain Tumors, Central Nervous System Tumors, Leptomeningeal Metastases

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Trial Information

A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases


- 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

- 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:


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:


Principal Investigator

Thomas H. Davis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center


United States: Data and Safety Monitoring Board

Study ID:




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



Norris Cotton Cancer Center Lebanon, New Hampshire  03756