Status:
WITHDRAWN
Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leptomeningeal Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot clinical trial studies continuous intraventricular methotrexate in treating patients with leptomeningeal disease. Drugs used in chemotherapy, such as methotrexate, work in different ways to...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the pharmacokinetics and efficacy of continuous intraventricular methotrexate infusion in the treatment of leptomeningeal disease. SECONDARY OBJECTIVES: I. Describe...
Eligibility Criteria
Inclusion
- Subjects with leptomeningeal carcinomatosis (from solid tumors)
- Subjects with lymphomatous or leukemic meningitis
- The effects of methotrexate on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following the conclusion of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she will be excluded from the study and should inform her treating physical immediately
- Karnofsky Performance Status greater than 70%
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- We will exclude subjects who have had prior intrathecal/intraventricular therapy with methotrexate within 6 months
Exclusion
- Prior therapy with methotrexate for management of leptomeningeal disease
- Subjects with evidence of hydrocephalous
- Subjects with intraparenchymal lesions or bulky disease
- Subjects with ventriculoperitoneal shunt in place
- Previous history of whole brain radiation therapy
- Subjects who, in the opinion of the principal investigator, may not be able to comply with the safety monitoring requirements of the study will not be included in this trial
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01438021
Start Date
September 1 2012
Last Update
November 9 2012
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