Leptomeningeal MetastasesNCT01438021
Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease
A study testing pharmacological study and methotrexate in people with Leptomeningeal Metastases, run by City of Hope Medical Center.
Trial summary
This pilot clinical trial studies continuous intraventricular methotrexate in treating patients with leptomeningeal disease. Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Metastases
- What is being tested?
- pharmacological study and methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Nov 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with leptomeningeal carcinomatosis (from solid tumors)
- Subjects with lymphomatous or leukemic meningitis
- The effects of methotrexate on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following the conclusion of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she will be excluded from the study and should inform her treating physical immediately
- Karnofsky Performance Status greater than 70%
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- We will exclude subjects who have had prior intrathecal/intraventricular therapy with methotrexate within 6 months
Who cannot join
- Prior therapy with methotrexate for management of leptomeningeal disease
- Subjects with evidence of hydrocephalous
- Subjects with intraparenchymal lesions or bulky disease
- Subjects with ventriculoperitoneal shunt in place
- Previous history of whole brain radiation therapy
- Subjects who, in the opinion of the principal investigator, may not be able to comply with the safety monitoring requirements of the study will not be included in this trial
About this study
Official title: Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease
This pilot clinical trial studies continuous intraventricular methotrexate in treating patients with leptomeningeal disease. Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the ventricles may be an effective treatment for patients with leptomeningeal disease
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the pharmacokinetics and efficacy of continuous intraventricular methotrexate infusion in the treatment of leptomeningeal disease.
SECONDARY OBJECTIVES:
- Describe the dose limiting toxicities. II. Describe the pharmacodynamics of continuously delivered intraventricular methotrexate.
III. Assess for response.
OUTLINE:
Patients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Leptomeningeal Metastases
- Being tested
- pharmacological study, methotrexate
- Keywords
- unspecified adult solid tumor, protocol specific
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called pharmacological studies
Correlative studies
methotrexateDrug
Also called amethopterin, Folex, methylaminopterin, Mexate
Given intraventricularly
| Study group | Role | What they receive |
|---|---|---|
| Treatment (intraventricular chemotherapy) | Experimental | Patients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Other: pharmacological study; Drug: methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of continuously delivered intraventricular methotrexate
The concentration of methotrexate in the brain parenchyma will be determined with microdialysis probe placed next to the ventricle.
Measured: Day 3 after start of treatment
Pharmacokinetics of continuous intraventricular infusion of methotrexate
Determined by measuring brain interstitial levels of methotrexate using microdialysis catheters, lumbar cerebral spinal fluid (CSF) levels (a distant site) of methotrexate via a lumbar drain during the inpatients phase, ventricular CSF levels of methotrexate using the Ommaya reservoir, and systemic levels of methotrexate in the blood.
Measured: Day 14 after start of treatment
Secondary outcomes (3)
Response rate of continuous intraventricular methotrexate infusion
Measured: Day 42 after start of treatment
Toxicities of continuous intraventricular methotrexate infusion
Measured: Day 3 after start of treatment
Pharmacodynamics of continuously delivered intraventricular methotrexate
Measured: Day 42 after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startSep 2012
- Primary completionNov 2013 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal MetastasesStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mike Chen, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438021
- Sponsor's protocol ID
- 09201
- Other IDs
- NCI-2011-03006
- Status last verified
- Nov 2012
- First submitted
- 19 Sep 2011
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease
- ClinicalTrials.gov ID
- NCT01438021
- Acronym / sponsor ID
- 09201
- Conditions
- Leptomeningeal Metastases
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (estimated)
- First posted
- 21 Sep 2011 (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.
This pilot clinical trial studies continuous intraventricular methotrexate in treating patients with leptomeningeal disease. Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the ventricles may be an effective treatment for patients with leptomeningeal disease
Detailed description
PRIMARY OBJECTIVES:
- Determine the pharmacokinetics and efficacy of continuous intraventricular methotrexate infusion in the treatment of leptomeningeal disease.
SECONDARY OBJECTIVES:
- Describe the dose limiting toxicities. II. Describe the pharmacodynamics of continuously delivered intraventricular methotrexate.
III. Assess for response.
OUTLINE:
Patients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (intraventricular chemotherapy) | Experimental | Other: pharmacological study, Drug: methotrexatePatients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with leptomeningeal carcinomatosis (from solid tumors)
- Subjects with lymphomatous or leukemic meningitis
- The effects of methotrexate on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following the conclusion of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she will be excluded from the study and should inform her treating physical immediately
- Karnofsky Performance Status greater than 70%
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (6 listed)
- Prior therapy with methotrexate for management of leptomeningeal disease
- Subjects with evidence of hydrocephalous
- Subjects with intraparenchymal lesions or bulky disease
- Subjects with ventriculoperitoneal shunt in place
- Previous history of whole brain radiation therapy
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 |
|---|---|---|
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (intraventricular chemotherapy) |
| methotrexateAlso: amethopterin, Folex, methylaminopterin, MexateGiven intraventricularly | Drug | Treatment (intraventricular chemotherapy) |
Primary outcome
Efficacy of continuously delivered intraventricular methotrexate
Time frame: Day 3 after start of treatment
The concentration of methotrexate in the brain parenchyma will be determined with microdialysis probe placed next to the ventricle.
Pharmacokinetics of continuous intraventricular infusion of methotrexate
Time frame: Day 14 after start of treatment
Determined by measuring brain interstitial levels of methotrexate using microdialysis catheters, lumbar cerebral spinal fluid (CSF) levels (a distant site) of methotrexate via a lumbar drain during the inpatients phase, ventricular CSF levels of methotrexate using the Ommaya reservoir, and systemic levels of methotrexate in the blood.
3 secondary outcomes
Response rate of continuous intraventricular methotrexate infusion
Time frame: Day 42 after start of treatment
Toxicities of continuous intraventricular methotrexate infusion
Time frame: Day 3 after start of treatment
Pharmacodynamics of continuously delivered intraventricular methotrexate
Time frame: Day 42 after start of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
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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.
Mike Chen, MD principal investigator
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing pharmacological study and methotrexate in people with Leptomeningeal Metastases, run by City of Hope Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of continuously delivered intraventricular methotrexate (time frame: Day 3 after start of treatment). The study lists 2 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 9 Nov 2012.