Status:
COMPLETED
Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Chronic Myeloproliferative Disorders
Eligibility:
All Genders
18-120 years
Phase:
EARLY_PHASE1
Brief Summary
RATIONALE: Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Studying samples of cerebrospinal fluid and blood from patients with cancer i...
Detailed Description
OBJECTIVES: * Determine the cerebrospinal fluid (CSF):plasma ratio of pemetrexed disodium at different IV dose levels in patients with leptomeningeal metastases. * Determine the safety of this drug i...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of systemic malignancy (solid tumor or hematologic malignancy) or primary CNS lymphoma with leptomeningeal metastases (LM) as documented by MRI, cerebrospinal fluid, or both
- Patients may have brain metastases in addition to LM
- Patients with clinically significant interstitial fluid with effusion controlled by drainage are eligible
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy \> 2 months
- Creatinine clearance ≥ 45 mL/min
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- Transaminases \< 3.0 times ULN (5 times ULN for hepatic metastasis)
- WBC \> 3,000/mm³
- Neutrophil count \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Hemoglobin \> 10 g/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Able to undergo lumbar puncture (i.e., no noncommunicating hydrocephalus or spinal block) or has an Ommaya reservoir in place
- Able to take steroids, cyanocobalamin (vitamin B12), and folic acid
- No other active cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix
- Patients with prior malignancies who are in complete remission and are off all therapy for that malignancy for ≥ 3 years are eligible
- No significant medical or psychiatric illness that would interfere with study compliance
- PRIOR CONCURRENT THERAPY:
- More than 2 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- No nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid within 2 days before or after study treatment (5 days for long-acting NSAIDs)
- No other concurrent cytotoxic chemotherapy
- Concurrent hormonal or biological therapy allowed
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00424242
Start Date
January 1 2007
End Date
September 1 2011
Last Update
September 8 2021
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013