DepoCyt for Active Lymphomatous or Leukemic Meningitis

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Enzon Pharmaceuticals, Inc.
• Treatments: Cytarabine

Criteria

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 eligible

• 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