Clinical trial NCT01438021: Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease
Official title: Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Leptomeningeal Metastases
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the ventricles may be an effective treatment for patients with leptomeningeal disease

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 the dose limiting toxicities. II. Describe the pharmacodynamics of continuously delivered intraventricular methotrexate.

III. Assess for response.

OUTLINE:

Patients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Efficacy of continuously delivered intraventricular methotrexate
timeFrame: Day 3 after start of treatment
measure: Pharmacokinetics of continuous intraventricular infusion of methotrexate
timeFrame: Day 14 after start of treatment
Secondary outcomes:
measure: Response rate of continuous intraventricular methotrexate infusion
timeFrame: Day 42 after start of treatment
measure: Toxicities of continuous intraventricular methotrexate infusion
timeFrame: Day 3 after start of treatment
measure: Pharmacodynamics of continuously delivered intraventricular methotrexate
timeFrame: Day 42 after start of treatment
Other outcomes:
Locations:
Study officials:
affiliation: City of Hope Medical Center
name: Mike Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: