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Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease


N/A
18 Years
N/A
Not Enrolling
Both
Leptomeningeal Metastases

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Trial Information

Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of continuously delivered intraventricular methotrexate

Outcome Description:

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

Outcome Time Frame:

Day 3 after start of treatment

Safety Issue:

No

Principal Investigator

Mike Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Institutional Review Board

Study ID:

09201

NCT ID:

NCT01438021

Start Date:

September 2012

Completion Date:

Related Keywords:

  • Leptomeningeal Metastases
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis
  • Meningeal Carcinomatosis

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