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

Phase 2
18 Years
Not Enrolling
Neoplastic Meningitis, Lymphoma, B Cell

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Trial Information

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.

Inclusion Criteria:

- Cytologically confirmed, or radiographic evidence for lymphomatous or leukemic
meningitis. If the CSF cytology is negative, patients must have MRI/CT brain and
clinical findings consistent with neoplastic meningitis.

- Karnofsky Performance Score of 60 or above.

- Age ≥ 18 years.

- Patients must have adequate hematologic, renal and liver function. Laboratory

- Absolute neutrophil count (ANC) ≥ 1,500/mm3 or white blood cell count > 3,000/mm3

- Platelet count ≥ 100, 000/mm3

- BUN and serum creatinine must be ≤ 1.5 times upper limit of laboratory normal

- Total and direct serum bilirubin must be ≤ 1.5 times upper limit of laboratory normal

- SGOT and SGPT ≤ 3.0 times upper limit of laboratory normal

- Alkaline phosphatase derived from liver ≤ 2.0 times upper limit of laboratory normal

- No uncontrolled infection other than human immunodeficiency virus that is being
treated with anti-retroviral therapy

- Patients who have had prior CNS radiation, prior intrathecal methotrexate, and prior
CNS prophylaxis with intrathecal or intravenous cytarabine or methotrexate are

- Written informed consent

Exclusion Criteria:

- Experimental/Investigational chemotherapy, immunotherapy, or biologic therapy within
four weeks prior to study

- Concurrent systemic chemotherapy with high dose methotrexate, high dose cytarabine,
or high dose thiotepa (they cross the blood brain barrier at high levels)

- Patients receiving whole brain radiotherapy or craniospinal irradiation

- Previous (less than 2 years from diagnosis) or concurrent malignancies at other sites
with the exception of fully treated carcinoma in situ of the cervix, basal cell
carcinoma of the skin, and squamous cell carcinoma of the skin, or prostate cancer
not requiring ongoing chemotherapy

- Pregnant or lactating women

- Known active meningeal infection

- Evidence of obstructive hydrocephalus requiring neurosurgical intervention

Type of Study:


Study Design:

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

Outcome Measure:

Response Rate

Outcome Description:

To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

David Rizzieri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:




Start Date:

June 2006

Completion Date:

June 2009

Related Keywords:

  • Neoplastic Meningitis
  • Lymphoma, B Cell
  • Lymphoma
  • Leukemia
  • Leukemic Meningitis
  • Lymphomatous Meningitis
  • Lymphoma
  • Meningitis
  • Lymphoma, B-Cell
  • Meningeal Carcinomatosis



Duke University Medical Center Durham, North Carolina  27710