Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma

• Status: Terminated
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Temozolomide

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