Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease

NCT01438021 | Withdrawn DMC

• 2 other identifiers: 09201NCI-2011-03006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Leptomeningeal Metastases

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• Efficacy of continuously delivered intraventricular methotrexate

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

  Day 3 after start of treatment

• Pharmacokinetics of continuous intraventricular infusion of methotrexate

  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.

  Day 14 after start of treatment

Secondary Outcomes (3)

• Response rate of continuous intraventricular methotrexate infusion

  Day 42 after start of treatment

• Toxicities of continuous intraventricular methotrexate infusion

  Day 3 after start of treatment

• Pharmacodynamics of continuously delivered intraventricular methotrexate

  Day 42 after start of treatment

Study Arms (1)

Treatment (intraventricular chemotherapy)

EXPERIMENTAL

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

Other: pharmacological study; Drug: methotrexate

Interventions

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (intraventricular chemotherapy)

methotrexate DRUG

Given intraventricularly

Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX

Treatment (intraventricular chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Meningeal Carcinomatosis

Interventions

Methotrexate; merphos

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mike Chen, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 21, 2011
• Study Start: September 1, 2012
• Primary Completion: November 1, 2013
• Last Updated: November 9, 2012

Record last verified: 2012-11