Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00523939
Study type Interventional
Source Duke University
Contact
Status Terminated
Phase Phase 2
Start date June 2006
Completion date June 2009

See also
  Status Clinical Trial Phase
Terminated NCT00512460 - RTA 744 Injection in Patients With Leptomeningeal Disease Phase 1
Completed NCT00674674 - Phase 1 Intrathecal Topotecan for Neoplastic Meningitis Phase 1
Completed NCT00924820 - A Pilot Study of Bevacizumab for Neoplastic Meningitis Phase 1/Phase 2
Terminated NCT00515788 - DepoCyt Plus Temozolomide in Patients With Neoplastic Meningitis Phase 1
Terminated NCT00964743 - Depocyt® With Sorafenib in Neoplastic Meningitis N/A