Lymphoma, B Cell, Neoplastic Meningitis
Conditions
Keywords
Lymphoma, Leukemia, Leukemic Meningitis, Lymphomatous Meningitis
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.
Interventions
DRUGcytarabine liposome injection
50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses
Sponsors
Enzon Pharmaceuticals, Inc.
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Time to Neurologic Progression | 2 years |
Countries
United States
Participant flow
Recruitment details
Recruitment June 2006 - September 2008. Study stopped early due to poor accrual.
Participants by arm
| Arm | Count |
|---|---|
| Lymphomatous Subjects with Lymphomatous Meningitis | 2 |
| Leukemic Subjects with Leukemic Meningitis | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Lymphomatous | Leukemic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 4 |
| serious Total, serious adverse events | 3 / 4 |
Outcome results
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.
Time frame: 1 year
Population: Primary outcome measure was not assessed due to early study termination.
Secondary
Time to Neurologic Progression
Time frame: 2 years