Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00005812
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00005812
Study Brief:
Protocol Section:
NCT00005812