Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
Brain Tumors, Central Nervous System Tumors, Leptomeningeal Metastases
About this trial
This is an interventional treatment trial for Brain Tumors focused on measuring leptomeningeal metastases, temozolomide
Eligibility 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
Sites / Locations
- Norris Cotton Cancer Center
Arms of the Study
Arm 1
Experimental
Temozolomide
Oral temozolomide 75 mg/m2/day for 6 weeks, followed by 4 week break. Cycles will continue until: disease progression intolerable toxicity complete response - 2 full additional cycles if response is complete except for residual radiographic abnormalities that persist unchanged for 2 full cycles: continue for 4 cycles past best response.