Expired Study
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Lebanon, New Hampshire 03756


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00005812


Primary Contact:

Study Chair
Thomas H. Davis, MD
Norris Cotton Cancer Center


Backup Contact:

N/A


Location Contact:

Lebanon, New Hampshire 03756
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

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