Brain and Central Nervous System TumorsPhase 1NCT00416923
Intrathecal Rituximab in Treating Patients With Recurrent CNS Lymphoma
A Phase 1 study testing rituximab in people with Brain and Central Nervous System Tumors and Lymphoma, run by University of California, San Francisco.
Trial summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Lymphoma
- What is being tested?
- rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Cytologically confirmed relapsed CNS lymphoma
- Arising from primary CNS lymphoma or systemic non-Hodgkin's lymphoma
- Evidence of brain parenchymal involvement, cerebrospinal fluid (CSF) involvement, or ocular involvement after radiation treatment or intrathecal chemotherapy
- Tumors must be CD20+ on pathologic analysis
- Refractory or persistent disease allowed
- No complete obstruction of the CSF pathway within the ventricular system unless alleviated by external beam radiotherapy or systemic chemotherapy
- No obstructive hydrocephalus
PATIENT CHARACTERISTICS:
- Karnofsky performance status > 50%
- Must have an Ommaya reservoir
- Granulocyte count > 1,500/mm^3
- Platelet count > 50,000/mm^3
- Anticipated survival ≥ 1 month
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from toxicity of prior therapy
- Prior intrathecal methotrexate, cytarabine, or thiotepa for CNS lymphoma allowed
- Concurrent systemic chemotherapy for treatment of disease outside meninges allowed except for high-dose methotrexate, high-dose cytarabine, high-dose thiotepa, or investigational agents
- No history of whole-brain or craniospinal radiation < 1 week before study entry
- No history of intrathecal chemotherapy < 1 week before study entry
- No concurrent intrathecal chemotherapy
About this study
Official title: Phase I Study of Intrathecal Rituximab in Patients With Recurrent CNS Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab intrathecally may be an effective treatment for recurrent CNS lymphoma.
PURPOSE: This phase I trial is studying the side effects and best dose of intrathecal rituximab in treating patients with recurrent CNS lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety and pharmacokinetics of intrathecal rituximab in patients with recurrent CNS lymphoma arising from CD20+ B-cell non-Hodgkin's lymphoma.
Secondary
- Determine the efficacy of intrathecal rituximab.
- Determine the molecular pathogenesis of lymphomatous meningitis.
- Determine the molecular basis for response or lack of response to rituximab.
- Identify molecular markers specific for lymphomatous meningitis that will be useful for prognostic evaluation of peripheral lymphomas.
- Determine the quality of life of patients treated with intrathecal rituximab.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive rituximab intrathecally over 10 minutes on day 1 in week 1 and on days 1 and 4 in weeks 2-5 in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial response with no rituximab-related neurotoxicity may continue to receive treatment beyond 5 weeks.
Cohorts of patients receive escalating doses of rituximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which fewer than 1/3 of patients experience dose-limiting toxicity.
Quality of life is assessed at baseline and at the completion of study treatment.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors, Lymphoma
- Being tested
- rituximab
- Keywords
- recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma
- Medical subject headings
- Central Nervous System Neoplasms, Lymphoma, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
| Study group | Role | What they receive |
|---|---|---|
| intrathecal rituximab | Experimental | 3 dose levels of intrathecal rituximab, 10mg, 25mg, 50mg Receives: Biological: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events as a measure of safety of intrathecal administration of Rituximab
Measured: up to 5 years after completion of 5 week study treatment
Serum concentration of Rituximab
Measured: during 5 weeks of study treatment
Cerebrospinal Fluid (CSF) concentration of Rituximab
Measured: during 5 weeks of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startAug 2002
- Primary completionNov 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 Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James L. Rubenstein, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416923
- Sponsor's protocol ID
- CDR0000454842
- Other IDs
- UCSF-01302, UCSF-H9414-19588-04, UCSF-U2337S, GENENTECH-UCSF-01302
- Status last verified
- Feb 2015
- First submitted
- 27 Dec 2006
- Last updated
- 16 Feb 2015
- Results posted
- No
Publications
Rubenstein JL, Fridlyand J, Abrey L, Shen A, Karch J, Wang E, Issa S, Damon L, Prados M, McDermott M, O'Brien J, Haqq C, Shuman M. Phase I study of intraventricular administration of rituximab in patients with recurrent CNS and intraocular lymphoma. J Clin Oncol. 2007 Apr 10;25(11):1350-6. doi: 10.1200/JCO.2006.09.7311. Epub 2007 Feb 20.
PubMed 17312328
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Intrathecal Rituximab in Patients With Recurrent CNS Lymphoma
- ClinicalTrials.gov ID
- NCT00416923
- Acronym / sponsor ID
- CDR0000454842
- Conditions
- Brain and Central Nervous System Tumors, Lymphoma
- Keywords
- recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 28 Dec 2006 (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: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab intrathecally may be an effective treatment for recurrent CNS lymphoma.
PURPOSE: This phase I trial is studying the side effects and best dose of intrathecal rituximab in treating patients with recurrent CNS lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the safety and pharmacokinetics of intrathecal rituximab in patients with recurrent CNS lymphoma arising from CD20+ B-cell non-Hodgkin's lymphoma.
Secondary
- Determine the efficacy of intrathecal rituximab.
- Determine the molecular pathogenesis of lymphomatous meningitis.
- Determine the molecular basis for response or lack of response to rituximab.
- Identify molecular markers specific for lymphomatous meningitis that will be useful for prognostic evaluation of peripheral lymphomas.
- Determine the quality of life of patients treated with intrathecal rituximab.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive rituximab intrathecally over 10 minutes on day 1 in week 1 and on days 1 and 4 in weeks 2-5 in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial response with no rituximab-related neurotoxicity may continue to receive treatment beyond 5 weeks.
Cohorts of patients receive escalating doses of rituximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which fewer than 1/3 of patients experience dose-limiting toxicity.
Quality of life is assessed at baseline and at the completion of study treatment.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intrathecal rituximab | Experimental | Biological: rituximab3 dose levels of intrathecal rituximab, 10mg, 25mg, 50mg |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| rituximab | Biological | intrathecal rituximab |
Primary outcome
Adverse events as a measure of safety of intrathecal administration of Rituximab
Time frame: up to 5 years after completion of 5 week study treatment
Serum concentration of Rituximab
Time frame: during 5 weeks of study treatment
Cerebrospinal Fluid (CSF) concentration of Rituximab
Time frame: during 5 weeks of study treatment
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 16 Feb 2015.
- Results publication: PubMed 17312328Rubenstein JL, Fridlyand J, Abrey L, Shen A, Karch J, Wang E, Issa S, Damon L, Prados M, McDermott M, O'Brien J, Haqq C, Shuman M. Phase I study of intraventricular administration of rituximab in patients with recurrent CNS and intraocular lymphoma. J Clin Oncol. 2007 Apr 10;25(11):1350-6. doi: 10.1200/JCO.2006.09.7311. Epub 2007 Feb 20.
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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.
James L. Rubenstein, MD, PhD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rituximab in people with Brain and Central Nervous System Tumors and Lymphoma, run by University of California, San Francisco.
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 16 Feb 2015. 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.
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 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?
Adverse events as a measure of safety of intrathecal administration of Rituximab (time frame: up to 5 years after completion of 5 week study treatment). The study lists 3 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 NCT00416923, 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 16 Feb 2015.