Clinical Trial: Intrathecal Gemcitabine to Treat Neoplastic Meningitis, IT Gemcitabine

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Intrathecal Gemcitabine Therapy for Neoplastic Meningitis: A Phase I and Pharmacokinetic Study

Brief 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.

Detailed Summary:

WHAT IS INVOLVED IN THE STUDY? Before participating in this study, there will be a screening process.

Administration:

Gemcitabine will be received directly into the cerebrospinal fluid (fluid that circulates around the brain and spinal cord) through an Ommaya reservoir (or other similar type of reservoir). An Ommaya reservoir is a surgically implanted catheter that is used to inject medication or to withdraw cerebrospinal fluid from the fluid chambers in the head.

All patients will be hospitalized overnight following their first dose of gemcitabine. If the first dose is well tolerated, further doses of gemcitabine will be administered in the outpatient clinic with close observation for a minimum of 2 hours after administration.

Weeks 1-6 Cohort 1a (first three patients):

Gemcitabine will be given once a week for 6 weeks. Patients may continue therapy if the disease has not worsened.

Weeks 1-6 (all other patients enrolled on this study):

Gemcitabine will be given twice a week for 6 weeks. Patients may continue therapy if the disease has not worsened.

Weeks 7-12:

Gemcitabine will be given once a week for 6 weeks.

Weeks 13-29 (approximately):

Gemcitabine will be given twice monthly for 4 months.

Weeks 30-52 (approximately):

Gemcitabine will be given monthly for the duration of the study
Sponsor: Baylor College of Medicine

Current Primary Outcome:

  • Asses the toxicity of intrathecally administered gemcitabine in a limited dosage escalation schedule. [ Time Frame: 1 year ]
  • Determination of the maximum tolerated dose of intrathecally administered gemcitabine. [ Time Frame: 4 weeks ]
    The MTD of IT gemcitabine will be that dose at which less than 20% of patients experience DLT as defined earlier. Escalations are planned in groups of three patients, with an additional three patients to be added at the first indication of DLT.


Original Primary Outcome:

Current Secondary Outcome:

  • To define the plasma and CSF pharmacokinetics of gemcitabine and its major metabolite, 2', 2'-difluoro-deoxyuridine (dFdU) after intrathecal administration. [ Time Frame: 1 year ]
  • Documentation of any responses following intrathecal gemcitabine administration. [ Time Frame: 1 year ]
  • Investigate MMP expression in pediatric and adult patients with a variety of primary diseases. [ Time Frame: 1 year ]


Original Secondary Outcome:

Information By: Baylor College of Medicine

Dates:
Date Received: December 16, 2003
Date Started: December 2001
Date Completion:
Last Updated: November 9, 2012
Last Verified: November 2012