DepoCyt for Active Lymphomatous or Leukemic Meningitis

NCT ID: NCT00523939

Last Updated: 2013-06-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-06-30

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 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.

Conditions

Neoplastic Meningitis; Lymphoma, B Cell

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lymphomatous

Subjects with Lymphomatous Meningitis

Group Type: EXPERIMENTAL

cytarabine liposome injection

Intervention Type: DRUG

50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses

Leukemic

Subjects with Leukemic Meningitis

Group Type: EXPERIMENTAL

cytarabine liposome injection

Intervention Type: DRUG

50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses

Interventions

cytarabine liposome injection

50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses

Intervention Type: DRUG

Other Intervention Names

DepoCyt

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enzon Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Rizzieri, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00009742

Identifier Type: -

Identifier Source: org_study_id