Phase II Study of Intrathecal Therapy With DepoCyt for Active Lymphomatous or Leukemic Meningitis
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.
David Rizzieri, MD
United States: Institutional Review Board
|Duke University Medical Center||Durham, North Carolina 27710|