Intrathecal Gemcitabine to Treat Neoplastic Meningitis, IT Gemcitabine

Summary

Subject's are being asked to take part in this study because he or she has a type of cancer that has spread to the meninges (tissues that cover the brain and spinal cord).

There is no known effective treatment for this specific disease or the subject has received all of the treatments that are known to work for his or her specific disease without success. Currently, there is no other effective treatment for this type of cancer.

The purposes of this study are:

* to determine the highest dose of gemcitabine, an anti-cancer drug, that can safely be given directly into the spinal fluid of children and adults whose cancer no longer responds to standard treatment;
* to find out what effects (good and bad) gemcitabine has when given directly into the cerebrospinal fluid (called intrathecal administration) in children and adults with neoplastic meningitis (cancer that has spread to the lining of the brain and spinal cord);
* to determine if gemcitabine is beneficial to the patient;
* to understand how gemcitabine is handled by the body after intrathecal administration.

Conditions

• Meningitis
• Neoplasms

Interventions

DRUG

Gemcitabine

Schedule Induction: At Dose Level 1athe first cohort of patients will receive intrathecal gemcitabine on a weekly basis for a total of 6 weeks. If that is tolerated, the subsequent cohort will receive intrathecal gemcitabine on a twice-weekly basis (Dose Level 1b) for a total of 6 weeks. Subsequent cohorts (Dose Levels 2 - 6) will receive intrathecal gemcitabine on a twice weekly basis for a total of 6 weeks (12 doses). In the absence of disease progression or DLT, patients may proceed to consolidation. Consolidation: Intrathecal gemcitabine will be administered weekly for a total of 6 doses. The first dose of consolidation will be given 1 week after the last induction dose. In the absence of disease progression or DLT, patients may proceed to maintenance. Maintenance: Intrathecal gemcitabine will be given twice monthly for 4 months and monthly thereafter. In the absence of progressive disease or dose-limiting toxicity, the total duration of therapy will be 1 year.

Sponsors & Collaborators

• University of Pittsburgh

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Hospital of Pittsburg

  collaborator UNKNOWN

• Seattle Children's Hospital

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Brown University

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Susan Blaney, MD · Baylor College of Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-12-31

Primary Completion

2005-07-31

Completion

2007-04-30

Countries

• United States

Study Locations