MeningitisPhase 1NCT00074607

Intrathecal Gemcitabine to Treat Neoplastic Meningitis, IT Gemcitabine

A Phase 1 study testing Gemcitabine in people with Meningitis and Neoplasms, run by Baylor College of Medicine at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Subject's are being asked to take part in this study because he or she has a type of cancer that has spread to the meninges (tissues that cover the brain and spinal cord). There is no known effective treatment for this specific disease or the subject has received all of the treatments that are known to work for his or… Read more about this study

Who is it for?: Ages 3 years and older
Conditions the study is for: Meningitis, Neoplasms
What is being tested?: Gemcitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 5 sitesUnited States
Study dates: Dec 2001to Apr 2007
Phase: 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 3 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

at least 3 years of age.
Neoplastic meningitis secondary to an underlying leukemia/lymphoma or a solid tumor (including primary CNS tumors or carcinomas of unknown primary site) for which there is no conventional therapy. Patients with CNS leukemia/lymphoma must be refractory to conventional therapy, including XRT (i.e. 2nd or greater relapse). Neoplastic meningitis is defined as follows:
Leukemia/Lymphoma: CSF cell count > 5 uL AND evidence of blast cells on cytospin preparation or by cytology.
Solid tumor: Presence of tumor cells on cytospin preparation or cytology OR presence of meningeal disease on MRI scans.
Life expectancy of at least 6 weeks.
Patients > 10 years old: Karnofsky performance status of >/= 50%. Patients </=10 years old: Lansky performance status of >/= 50%.

Show all 10Show fewer

Must have recovered from the acute neurotoxic effects of all prior chemo, immuno, or radiotherapy and must be without uncontrolled significant systemic illness (e.g. infection). Must not have received any systemic CNS-directed therapy within 3 weeks or craniospinal irradiation within 8 weeks prior to starting treatment on study. Must not have received any intrathecal therapy within 1 week prior to starting treatment on study.
Must have a platelet count >40,000/uL and HCT >30% and an ANC of > 1000/uL.
Must have adequate liver function, total bilirubin < 2.0 mg, SGPT < 5 times upper limits of normal; adequate renal function (serum creatinine < 2 times upper limits of normal for age).
Patients must have or be willing to have an intraventricular access device such as an Ommaya reservoir.

Who cannot join

Patients receiving other therapy (either intrathecal or systemic) designed to treat their leptomeningeal disease. However, patients receiving concomitant chemotherapy to control systemic disease or bulk CNS disease will be eligible, provided that the systemic chemotherapy is not a phase I agent, an agent that significantly penetrates the CSF, or an agent known to have serious unpredictable CNS side effects.
Nuclear Medicine CSF flow studies are required within the 2 weeks prior to study entry for all solid tumor patients. In leukemia/lymphoma patients a CSF flow study is only required if CSF analysis or an MRI suggests that there is a blockage to CSF flow. Patients with clinical evidence of obstructive hydrocephalus are not eligible for this protocol. Nor are patients with compartmentalization of CSF flow as documented by radioisotope Indium111 or Technetium99-DTPA flow eligible for this protocol. If a CSF flow block or compartmentalization is demonstrated, focal radiotherapy to the site of the block to restore flow followed by a repeat CSF flow study demonstrating clearing of the blockage is required for the patient to be eligible for the study.
Patients must not have clinically significant abnormalities of serum electrolytes, including calcium, magnesium, and phosphorus.
Patients with a ventriculoperitoneal (VP) or ventriculoatrial (VA) shunt are not eligible unless they are shunt-independent and there is evidence that their shunt is nonfunctional
Patients who have leukemia/lymphoma with a concomitant bone marrow relapse.
Women of childbearing age must not be pregnant or lactating. (Male and female patients who are fertile must be willing to use an effective means of birth control to avoid pregnancy.)

Show all 10Show fewer

Must be free of uncontrolled infection except HIV (i.e., AIDS-related lymphomatous meningitis).
Must NOT be receiving any other investigational agents and must not have received any other investigational agent within 14 days prior to study treatment. The 14-day period should be extended if the investigational agent is known to have delayed toxicity.
Patients with impending spinal cord compression, CNS involvement requiring local XRT (e.g. optic nerve), or isolated bulky ventricular or leptomeningeal based lesions are not eligible.
Concomitant CNS radiation therapy is not permitted. (Patients are not permitted to receive radiation to any port that encompasses any part of the brain or spine while on study.) Patients may receive radiation therapy to extra-CNS sites, e.g. painful bone metastases not in the craniospinal axis.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

National Cancer Institute
Bethesda, Maryland, 20892
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
Seattle Children's Hospital
Seattle, Washington, 98105

Other trials in United States

About this study

Official title: Intrathecal Gemcitabine Therapy for Neoplastic Meningitis: A Phase I and Pharmacokinetic Study

Subject's are being asked to take part in this study because he or she has a type of cancer that has spread to the meninges (tissues that cover the brain and spinal cord).

There is no known effective treatment for this specific disease or the subject has received all of the treatments that are known to work for his or her specific disease without success. Currently, there is no other effective treatment for this type of cancer.

The purposes of this study are:

to determine the highest dose of gemcitabine, an anti-cancer drug, that can safely be given directly into the spinal fluid of children and adults whose cancer no longer responds to standard treatment;
to find out what effects (good and bad) gemcitabine has when given directly into the cerebrospinal fluid (called intrathecal administration) in children and adults with neoplastic meningitis (cancer that has spread to the lining of the brain and spinal cord);
to determine if gemcitabine is beneficial to the patient;
to understand how gemcitabine is handled by the body after intrathecal administration.

Read the detailed description

WHAT IS INVOLVED IN THE STUDY? Before participating in this study, there will be a screening process.

Administration:

Gemcitabine will be received directly into the cerebrospinal fluid (fluid that circulates around the brain and spinal cord) through an Ommaya reservoir (or other similar type of reservoir). An Ommaya reservoir is a surgically implanted catheter that is used to inject medication or to withdraw cerebrospinal fluid from the fluid chambers in the head.

All patients will be hospitalized overnight following their first dose of gemcitabine. If the first dose is well tolerated, further doses of gemcitabine will be administered in the outpatient clinic with close observation for a minimum of 2 hours after administration.

Weeks 1-6 Cohort 1a (first three patients):

Gemcitabine will be given once a week for 6 weeks. Patients may continue therapy if the disease has not worsened.

Weeks 1-6 (all other patients enrolled on this study):

Gemcitabine will be given twice a week for 6 weeks. Patients may continue therapy if the disease has not worsened.

Weeks 7-12:

Gemcitabine will be given once a week for 6 weeks.

Weeks 13-29 (approximately):

Gemcitabine will be given twice monthly for 4 months.

Weeks 30-52 (approximately):

Gemcitabine will be given monthly for the duration of the study.

For safety reasons, the first patients treated in the study will receive a low dose of gemcitabine. If that dose does not cause severe side effects, the next group will receive a higher dose of gemcitabine than given to the earlier group, or may receive a lower dose if side effects occur. In addition, the first three patients treated on this study will receive the gemcitabine once weekly. If this is tolerated, subsequent patients will receive the medication twice weekly.

Following the first dose of gemcitabine investigators would like to draw special blood and spinal fluid samples to help learn how much of the drug is in the blood and spinal fluid. These studies are called pharmacokinetics. A total of 10 samples will be collected. The blood samples may be collected from an intravenous catheter or a central venous catheter. The spinal fluid samples may be collected either via Ommaya reservoir or lumbar reservoir.

In addition to intrathecal gemcitabine, the patient may receive other chemotherapy, not given directly into the fluid surrounding the brain and spine, as recommended by his or her doctor for the treatment or prevention of cancer outside the lining of the brain and spinal cord.

The maximum length of treatment with gemcitabine is one year. However, at the end of the study, monthly check-ups are required to monitor the disease and to make sure that any side effects from the study drug have stopped.

Conditions: Meningitis, Neoplasms
Being tested: Gemcitabine
Keywords: Neoplastic meningitis
Medical subject headings: Meningitis, Neoplasms, Meningeal Carcinomatosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GemcitabineDrug
Also called Gemzar
Schedule
Induction: At Dose Level 1athe first cohort of patients will receive intrathecal gemcitabine on a weekly basis for a total of 6 weeks. If that is tolerated, the subsequent cohort will receive intrathecal gemcitabine on a twice-weekly basis (Dose Level 1b) for a total of 6 weeks. Subsequent cohorts (Dose Levels 2 - 6) will receive intrathecal gemcitabine on a twice weekly basis for a total of 6 weeks (12 doses).
In the absence of disease progression or DLT, patients may proceed to consolidation.
Consolidation: Intrathecal gemcitabine will be administered weekly for a total of 6 doses. The first dose of consolidation will be given 1 week after the last induction dose. In the absence of disease progression or DLT, patients may proceed to maintenance.
Maintenance: Intrathecal gemcitabine will be given twice monthly for 4 months and monthly thereafter. In the absence of progressive disease or dose-limiting toxicity, the total duration of therapy will be 1 year.

Study groups in NCT00074607
Study group	Role	What they receive
Intrathecal gemcitabine administration	Experimental	Intrathecal gemcitabine will be given on a weekly schedule for the first cohort of patients at the 5 mg dose level and then a twice-weekly (i.e., every 3 to 4 days) schedule. Drug administration will be by the intraventricular (Ommaya reservoir injection) route. Patients will be hospitalized overnight following their first dose of gemcitabine. If the first dose is well tolerated, subsequent induction doses may be administered in the outpatient setting with close observation for a minimum of 2 hours after administration. Dose Levels and Dose Escalation: Dose Level 1a: 5 mg Dose Level 1b: 5 mg Dose Level 2: 10 mg Dose Level 3: 20 mg Dose Level 4: 30 mg Dose Level 5: 40 mg Dose Level 6: 50 mg Receives: Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Asses the toxicity of intrathecally administered gemcitabine in a limited dosage escalation schedule.
Measured: 1 year
Determination of the maximum tolerated dose of intrathecally administered gemcitabine.
The MTD of IT gemcitabine will be that dose at which less than 20% of patients experience DLT as defined earlier. Escalations are planned in groups of three patients, with an additional three patients to be added at the first indication of DLT.
Measured: 4 weeks

Secondary outcomes (3)

To define the plasma and CSF pharmacokinetics of gemcitabine and its major metabolite, 2', 2'-difluoro-deoxyuridine (dFdU) after intrathecal administration.
Measured: 1 year
Documentation of any responses following intrathecal gemcitabine administration.
Measured: 1 year
Investigate MMP expression in pediatric and adult patients with a variety of primary diseases.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2001Apr 2007

First posted18 Dec 2003 (estimated)
Study startDec 2001
Primary completionJul 2005
Study completionApr 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MeningitisStudies of the same condition, open and under way.
More trials run by Baylor College of MedicineThe 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00074607
Sponsor's protocol ID: H10564 IT Gemcitabine
Other IDs: I.T. Gemcitabine
Status last verified: Nov 2012
First submitted: 16 Dec 2003
Last updated: 12 Nov 2012
Results posted: No
Data monitoring committee: Yes

Publications

Bernardi RJ, Bomgaars L, Fox E, Balis FM, Egorin MJ, Lagattuta TF, Aikin A, Whitcomb P, Renbarger J, Lieberman FS, Berg SL, Blaney SM. Phase I clinical trial of intrathecal gemcitabine in patients with neoplastic meningitis. Cancer Chemother Pharmacol. 2008 Jul;62(2):355-61. doi: 10.1007/s00280-007-0601-x. Epub 2007 Oct 2.
PubMed 17909804

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intrathecal Gemcitabine Therapy for Neoplastic Meningitis: A Phase I and Pharmacokinetic Study
ClinicalTrials.gov ID: NCT00074607
Acronym / sponsor ID: H10564 IT Gemcitabine
Conditions: Meningitis, Neoplasms
Keywords: Neoplastic meningitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 10 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Collaborators: University of Pittsburgh, National Cancer Institute (NCI), Children's Hospital of Pittsburg, Seattle Children's Hospital, Mayo Clinic, Brown University
Study start: Dec 2001
Primary completion: Jul 2005 (actual)
Study completion: Apr 2007 (actual)
First posted: 18 Dec 2003 (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.

Subject's are being asked to take part in this study because he or she has a type of cancer that has spread to the meninges (tissues that cover the brain and spinal cord).

The purposes of this study are:

to determine the highest dose of gemcitabine, an anti-cancer drug, that can safely be given directly into the spinal fluid of children and adults whose cancer no longer responds to standard treatment;
to find out what effects (good and bad) gemcitabine has when given directly into the cerebrospinal fluid (called intrathecal administration) in children and adults with neoplastic meningitis (cancer that has spread to the lining of the brain and spinal cord);
to determine if gemcitabine is beneficial to the patient;
to understand how gemcitabine is handled by the body after intrathecal administration.

Detailed description

WHAT IS INVOLVED IN THE STUDY? Before participating in this study, there will be a screening process.

Administration:

Weeks 1-6 Cohort 1a (first three patients):

Gemcitabine will be given once a week for 6 weeks. Patients may continue therapy if the disease has not worsened.

Weeks 1-6 (all other patients enrolled on this study):

Gemcitabine will be given twice a week for 6 weeks. Patients may continue therapy if the disease has not worsened.

Weeks 7-12:

Gemcitabine will be given once a week for 6 weeks.

Weeks 13-29 (approximately):

Gemcitabine will be given twice monthly for 4 months.

Weeks 30-52 (approximately):

Gemcitabine will be given monthly for the duration of the study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intrathecal gemcitabine administration	Experimental	Drug: GemcitabineIntrathecal gemcitabine will be given on a weekly schedule for the first cohort of patients at the 5 mg dose level and then a twice-weekly (i.e., every 3 to 4 days) schedule. Drug administration will be by the intraventricular (Ommaya reservoir injection) route. Patients will be hospitalized overnight following their first dose of gemcitabine. If the first dose is well tolerated, subsequent induction doses may be administered in the outpatient setting with close observation for a minimum of 2 hours after administration. Dose Levels and Dose Escalation: Dose Level 1a: 5 mg Dose Level 1b: 5 mg Dose Level 2: 10 mg Dose Level 3: 20 mg Dose Level 4: 30 mg Dose Level 5: 40 mg Dose Level 6: 50 mg

Who may qualify

Ages: 3 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (10 listed)

at least 3 years of age.
Neoplastic meningitis secondary to an underlying leukemia/lymphoma or a solid tumor (including primary CNS tumors or carcinomas of unknown primary site) for which there is no conventional therapy. Patients with CNS leukemia/lymphoma must be refractory to conventional therapy, including XRT (i.e. 2nd or greater relapse). Neoplastic meningitis is defined as follows:
Life expectancy of at least 6 weeks.
Patients > 10 years old: Karnofsky performance status of >/= 50%. Patients </=10 years old: Lansky performance status of >/= 50%.
Must have recovered from the acute neurotoxic effects of all prior chemo, immuno, or radiotherapy and must be without uncontrolled significant systemic illness (e.g. infection). Must not have received any systemic CNS-directed therapy within 3 weeks or craniospinal irradiation within 8 weeks prior to starting treatment on study. Must not have received any intrathecal therapy within 1 week prior to starting treatment on study.

Key exclusion criteria (10 listed)

Patients receiving other therapy (either intrathecal or systemic) designed to treat their leptomeningeal disease. However, patients receiving concomitant chemotherapy to control systemic disease or bulk CNS disease will be eligible, provided that the systemic chemotherapy is not a phase I agent, an agent that significantly penetrates the CSF, or an agent known to have serious unpredictable CNS side effects.
Nuclear Medicine CSF flow studies are required within the 2 weeks prior to study entry for all solid tumor patients. In leukemia/lymphoma patients a CSF flow study is only required if CSF analysis or an MRI suggests that there is a blockage to CSF flow. Patients with clinical evidence of obstructive hydrocephalus are not eligible for this protocol. Nor are patients with compartmentalization of CSF flow as documented by radioisotope Indium111 or Technetium99-DTPA flow eligible for this protocol. If a CSF flow block or compartmentalization is demonstrated, focal radiotherapy to the site of the block to restore flow followed by a repeat CSF flow study demonstrating clearing of the blockage is required for the patient to be eligible for the study.
Patients must not have clinically significant abnormalities of serum electrolytes, including calcium, magnesium, and phosphorus.
Patients with a ventriculoperitoneal (VP) or ventriculoatrial (VA) shunt are not eligible unless they are shunt-independent and there is evidence that their shunt is nonfunctional
Patients who have leukemia/lymphoma with a concomitant bone marrow relapse.

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
GemcitabineAlso: GemzarSchedule Induction: At Dose Level 1athe first cohort of patients will receive intrathecal gemcitabine on a weekly basis for a total of 6 weeks. If that is tolerated, the subsequent cohort will receive intrathecal gemcitabine on a twice-weekly basis (Dose Level 1b) for a total of 6 weeks. Subsequent cohorts (Dose Levels 2 - 6) will receive intrathecal gemcitabine on a twice weekly basis for a total of 6 weeks (12 doses). In the absence of disease progression or DLT, patients may proceed to consolidation. Consolidation: Intrathecal gemcitabine will be administered weekly for a total of 6 doses. The first dose of consolidation will be given 1 week after the last induction dose. In the absence of disease progression or DLT, patients may proceed to maintenance. Maintenance: Intrathecal gemcitabine will be given twice monthly for 4 months and monthly thereafter. In the absence of progressive disease or dose-limiting toxicity, the total duration of therapy will be 1 year.	Drug	Intrathecal gemcitabine administration

Primary outcome

Asses the toxicity of intrathecally administered gemcitabine in a limited dosage escalation schedule.
Time frame: 1 year
Determination of the maximum tolerated dose of intrathecally administered gemcitabine.
Time frame: 4 weeks
The MTD of IT gemcitabine will be that dose at which less than 20% of patients experience DLT as defined earlier. Escalations are planned in groups of three patients, with an additional three patients to be added at the first indication of DLT.

3 secondary outcomes

To define the plasma and CSF pharmacokinetics of gemcitabine and its major metabolite, 2', 2'-difluoro-deoxyuridine (dFdU) after intrathecal administration.
Time frame: 1 year
Documentation of any responses following intrathecal gemcitabine administration.
Time frame: 1 year
Investigate MMP expression in pediatric and adult patients with a variety of primary diseases.
Time frame: 1 year

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
Results publication: PubMed 17909804Bernardi RJ, Bomgaars L, Fox E, Balis FM, Egorin MJ, Lagattuta TF, Aikin A, Whitcomb P, Renbarger J, Lieberman FS, Berg SL, Blaney SM. Phase I clinical trial of intrathecal gemcitabine in patients with neoplastic meningitis. Cancer Chemother Pharmacol. 2008 Jul;62(2):355-61. doi: 10.1007/s00280-007-0601-x. Epub 2007 Oct 2.

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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.

Susan Blaney, MD principal investigator

Baylor College of Medicine

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine in people with Meningitis and Neoplasms, run by Baylor College of Medicine at 5 sites 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?

The sponsor lists 10 inclusion and 10 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: stopped early, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was stopped early. Results are not available in the source record.

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?

Asses the toxicity of intrathecally administered gemcitabine in a limited dosage escalation schedule. (time frame: 1 year). 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?

On the ClinicalTrials.gov record for NCT00074607, which also lists 1 linked publication.

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 12 Nov 2012.