DepoCyt for Active Lymphomatous or Leukemic Meningitis

Lymphoma, B Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00523939
• Other study ID #: Pro00009742
• Status: Terminated
• Phase: Phase 2
• First received: August 31, 2007
• Last updated: June 7, 2013
• Start date: June 2006
• Est. completion date: June 2009

Study information

• Verified date: November 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B Cell
• Lymphoma, B-Cell
• Meningeal Carcinomatosis
• Meningitis
• Neoplastic Meningitis

Intervention

Drug:
• cytarabine liposome injection
50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Enzon Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.	1 year	No
Secondary	Time to Neurologic Progression		2 years	No