Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Lymphoma

Meningeal Carcinomatosis

Lymphoma, B-Cell

Meningitis

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neuroinflammatory Diseases

Lymphoma, Non-Hodgkin

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

B-cell Lymphoma

Lymphosarcoma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

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

cytarabine liposome injection

David Rizzieri, MD

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.

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.

DepoCyt for Active Lymphomatous or Leukemic Meningitis

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

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

Enzon Pharmaceuticals, Inc.

Duke University

Subjects with Lymphomatous or Leukemic Meningitis.

All Subjects

Lymphomatous

Leukemic

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Adverse events for both arms, lymphomatous and leukemic, were combined due to low accrual and early study termination.

Spots Global Cancer Trial Database for lymphomatous meningitis