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Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease

NCT ID: NCT01438021

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Leptomeningeal Metastases

Keywords

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unspecified adult solid tumor, protocol specific

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (intraventricular chemotherapy)

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

Group Type EXPERIMENTAL

pharmacological study

Intervention Type OTHER

Correlative studies

methotrexate

Intervention Type DRUG

Given intraventricularly

Interventions

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pharmacological study

Correlative studies

Intervention Type OTHER

methotrexate

Given intraventricularly

Intervention Type DRUG

Other Intervention Names

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pharmacological studies amethopterin Folex methylaminopterin Mexate MTX

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mike Chen, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Countries

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United States

Other Identifiers

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NCI-2011-03006

Identifier Type: REGISTRY

Identifier Source: secondary_id

09201

Identifier Type: -

Identifier Source: org_study_id