Clinical Trial: DepoCyt for Active Lymphomatous or Leukemic Meningitis

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

Official Title: Phase II Study of Intrathecal Therapy With DepoCyt for Active Lymphomatous or Leukemic Meningitis

Brief Summary: The purpose of this study is to determine the response rate of lymphomatous meningitis or leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well to the study drug, and the response of symptoms to the study drug will also be determined.

Detailed Summary:

DepoCyt is a sustained-release formulation of the chemotherapy drug, cytarabine (Ara-C), which is used for the treatment of patients with lymphomatous or leukemic meningitis, a complication of lymphoma/leukemia that is characterized by the spread of cancer to the central nervous system.

DepoCyt is introduced into the spinal fluid, through a needle inserted into the spinal canal or through a reservoir placed under the scalp by a neurosurgeon. DepoCyt will be given every two weeks i.e. week 1 and week 3 initially. After the second dose, a lumbar puncture will be done to check the spinal fluid for cancer cells. If there has been a good response, DepoCyt will be given every 14 days for 6 doses i.e., weeks 5, 7, 9, 11, 13, 15 and then every 28 days for six doses i.e., weeks 19, 23, 27, 31, 35, and 39. Blood tests and lumbar punctures will be done throughout the study.

Sponsor: Duke University

Current Primary Outcome: Response Rate [ Time Frame: 1 year ]

Original Primary Outcome: Response Rate [ Time Frame: 1 year ]

Current Secondary Outcome: Time to Neurologic Progression [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: August 31, 2007
Date Started: June 2006
Date Completion:
Last Updated: June 7, 2013
Last Verified: November 2012