Brain and Central Nervous System TumorsEarly Phase 1NCT00424242
Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
A Early Phase 1 study testing Pemetrexed in people with Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by Northwestern University at 1 site in United States.
Trial 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 in the laboratory may help doctors learn how pemetrexed disodium works in the body and identify biomarkers related to… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia
- What is being tested?
- Pemetrexed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Sep 2011
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
About this study
Official title: A Pharmacokinetic Study of Pemetrexed in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Metastatic Cancer
- Being tested
- Pemetrexed
- Keywords
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorders, Neoplasm Metastasis, Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called Alimta, LY231514
Orally beginning at 500 mg/m2 every 3 weeks until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Escalating doses of Pemetrexed | Experimental | Escalating doses of Pemetrexed beginning at 500 mg/m2 Receives: Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of cerebrospinal fluid levels with plasma levels of different doses of pemetrexed disodium
Patients will have CSF collected approximately every 6 weeks for assessment while on study.
Measured: Every 6 weeks for assessment while on study.
To determine whether there is any anti-tumor activity against LM with Pemetrexed.
Patients will have a scan every six weeks to assess tumor response.
Measured: Every six weeks.
To determine the safety of Pemetrexed in patients with LM.
Adverse events will be collected every six weeks during patient visits.
Measured: After every 2 doses approximately 6 weeks
To assess the role of serum biomarkers in patients with LM.
Patients will have a one time blood draw to look at serum biomarkers prior to dose one.
Measured: Prior to dose one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey J. Raizer, MD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424242
- Sponsor's protocol ID
- NU 06C2
- Other IDs
- STU00004482
- Status last verified
- Sep 2021
- First submitted
- 16 Jan 2007
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of Pemetrexed in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
- ClinicalTrials.gov ID
- NCT00424242
- Acronym / sponsor ID
- NU 06C2
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Metastatic Cancer
- Keywords
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Escalating doses of Pemetrexed | Experimental | Drug: PemetrexedEscalating doses of Pemetrexed beginning at 500 mg/m2 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedAlso: Alimta, LY231514Orally beginning at 500 mg/m2 every 3 weeks until disease progression | Drug | Escalating doses of Pemetrexed |
Primary outcome
Correlation of cerebrospinal fluid levels with plasma levels of different doses of pemetrexed disodium
Time frame: Every 6 weeks for assessment while on study.
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.
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
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
Patients will have a one time blood draw to look at serum biomarkers prior to dose one.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
Related trials for Brain and Central Nervous System Tumors
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J. Raizer, MD principal investigator
Robert H. Lurie Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pemetrexed in people with Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of cerebrospinal fluid levels with plasma levels of different doses of pemetrexed disodium (time frame: Every 6 weeks for assessment while on study.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.