Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease

• Sponsor: City of Hope Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01438021
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 0
• Arm: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Leptomeningeal Metastases	Other: pharmacological study; Drug: methotrexate	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. Determine the pharmacokinetics and efficacy of continuous intraventricular methotrexate infusion in the treatment of leptomeningeal disease.

SECONDARY OBJECTIVES:

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

2. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease
• Study Start Date: Sep 1, 2012
• Anticipated Primary Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (intraventricular chemotherapy) Patients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity.	Other: pharmacological study; Correlative studies; Other Names: pharmacological studies ; Drug: methotrexate; Given intraventricularly; Other Names: amethopterin Folex methylaminopterin Mexate MTX

Outcome Measures

Primary Outcome Measures

1. Efficacy of continuously delivered intraventricular methotrexate [Day 3 after start of treatment]

   The concentration of methotrexate in the brain parenchyma will be determined with microdialysis probe placed next to the ventricle.

2. Pharmacokinetics of continuous intraventricular infusion of methotrexate [Day 14 after start of treatment]

   Determined by measuring brain interstitial levels of methotrexate using microdialysis catheters, lumbar cerebral spinal fluid (CSF) levels (a distant site) of methotrexate via a lumbar drain during the inpatients phase, ventricular CSF levels of methotrexate using the Ommaya reservoir, and systemic levels of methotrexate in the blood.

Secondary Outcome Measures

1. Response rate of continuous intraventricular methotrexate infusion [Day 42 after start of treatment]

2. Toxicities of continuous intraventricular methotrexate infusion [Day 3 after start of treatment]

3. Pharmacodynamics of continuously delivered intraventricular methotrexate [Day 42 after start of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• City of Hope Medical Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Mike Chen, MD, City of Hope Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: City of Hope Medical Center
• ClinicalTrials.gov Identifier: NCT01438021
• Other Study ID Numbers: 09201; NCI-2011-03006
• First Posted: Sep 21, 2011
• Last Update Posted: Nov 9, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by City of Hope Medical Center: unspecified adult solid tumor, protocol specific
• Additional relevant MeSH terms: Neoplasm Metastasis; Methotrexate

Study Results

No Results Posted as of Nov 9, 2012