Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
This study is ongoing, but not recruiting participants.
Sponsor:
Northwestern University
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00424242
First received: January 16, 2007
Last updated: June 8, 2012
Last verified: June 2012
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Purpose
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 in the laboratory may help doctors learn how pemetrexed disodium works in the body and identify biomarkers related to cancer.
PURPOSE: This clinical trial is studying the side effects and how well pemetrexed disodium works in treating patients with leptomeningeal metastases.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Metastatic Cancer Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous Condition Secondary Myelofibrosis Unspecified Adult Solid Tumor, Protocol Specific |
Drug: Pemetrexed |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pharmacokinetic Study of Pemetrexed in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases |
Resource links provided by NLM:
Genetics Home Reference related topics:
essential thrombocythemia
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
polycythemia vera
primary myelofibrosis
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
U.S. FDA Resources
Further study details as provided by Northwestern University:
Primary Outcome Measures:
- Correlation of cerebrospinal fluid levels with plasma levels of different doses of pemetrexed disodium [ Time Frame: Every 6 weeks for assessment while on study. ] [ Designated as safety issue: Yes ]Patients will have CSF collected approximately every 6 weeks for assessment while on study.
- To determine whether there is any anti-tumor activity against LM with Pemetrexed. [ Time Frame: Every six weeks. ] [ Designated as safety issue: No ]Patients will have a scan every six weeks to assess tumor response.
- To determine the safety of Pemetrexed in patients with LM. [ Time Frame: After every 2 doses approximately 6 weeks ] [ Designated as safety issue: Yes ]Adverse events will be collected every six weeks during patient visits.
- To assess the role of serum biomarkers in patients with LM. [ Time Frame: Prior to dose one ] [ Designated as safety issue: No ]Patients will have a one time blood draw to look at serum biomarkers prior to dose one.
| Estimated Enrollment: | 15 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Escalating doses of Pemetrexed
Escalating doses of Pemetrexed beginning at 500 mg/m2
|
Drug: Pemetrexed
Orally beginning at 500 mg/m2 every 3 weeks until disease progression
Other Names:
|
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 in these patients.
- Determine the antitumor activity of this drug in these patients.
- Assess the role of CSF vascular endothelial growth factor and YKL 40 as markers of response and/or prognosis in these patients.
OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo lumbar puncture and blood collection prior to therapy and 30-60 minutes after the first dose of pemetrexed disodium for pharmacological studies. Patients with Ommaya reservoirs undergo cerebrospinal fluid (CSF) collection at baseline and 0.25, 0.50, 1, 2, 4, 6 and 8.0 hours after pemetrexed disodium administration. CSF is then obtained once during each subsequent course of study treatment. CSF and blood are also evaluated for YKL 40 and vascular endothelial growth factor.
After completion of study therapy, patients are followed every 2-3 months.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424242
Locations
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
Sponsors and Collaborators
Northwestern University
Investigators
| Principal Investigator: | Jeffrey J. Raizer, MD | Robert H. Lurie Cancer Center |
More Information
No publications provided
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00424242 History of Changes |
| Other Study ID Numbers: | NU 06C2, STU00004482 |
| Study First Received: | January 16, 2007 |
| Last Updated: | June 8, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
unspecified adult solid tumor, protocol specific tumors metastatic to brain leptomeningeal metastases primary central nervous system non-Hodgkin lymphoma primary central nervous system Hodgkin lymphoma meningeal chronic myelogenous leukemia relapsing chronic myelogenous leukemia chronic eosinophilic leukemia primary myelofibrosis chronic neutrophilic leukemia essential thrombocythemia polycythemia vera recurrent adult acute lymphoblastic leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) |
adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia previously treated myelodysplastic syndromes secondary acute myeloid leukemia acute undifferentiated leukemia mast cell leukemia recurrent adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma T-cell large granular lymphocyte leukemia atypical chronic myeloid leukemia, BCR-ABL negative stage IV chronic lymphocytic leukemia refractory chronic lymphocytic leukemia chronic myelomonocytic leukemia |
Additional relevant MeSH terms:
|
Primary Myelofibrosis Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Neoplasm Metastasis Neoplasms, Second Primary Nervous System Neoplasms |
Precancerous Conditions Lymphoma, Large-Cell, Immunoblastic Central Nervous System Neoplasms Meningeal Carcinomatosis Bone Marrow Diseases Hematologic Diseases Neoplasms by Histologic Type Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
ClinicalTrials.gov processed this record on May 16, 2013