- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00523939
DepoCyt for Active Lymphomatous or Leukemic Meningitis
Phase II Study of Intrathecal Therapy With DepoCyt for Active Lymphomatous or Leukemic Meningitis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lymphomatous
Subjects with Lymphomatous Meningitis
|
50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses
Other Names:
|
Experimental: Leukemic
Subjects with Leukemic Meningitis
|
50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: 1 year
|
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
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Neurologic Progression
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Rizzieri, MD, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Neoplasms by Site
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Meningeal Neoplasms
- Lymphoma
- Lymphoma, B-Cell
- Meningitis
- Meningeal Carcinomatosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cytarabine
Other Study ID Numbers
- Pro00009742
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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