LymphomaNCT00082836
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma
A study testing rituximab and yttrium Y 90 ibritumomab tiuxetan in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab and yttrium Y 90 ibritumomab tiuxetan
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to May 2007
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed non-Hodgkin's lymphoma (NHL)
- Recurrent disease
- Isolated CNS relapse of systemic NHL allowed
- Primary CNS lymphoma
- Measurable gadolinium-enhancing lesion on MRI of the brain
- No impaired bone marrow reserve
- No hypocellular bone marrow
- No marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid)
- No pleural effusion
- No chronic lymphocytic leukemia
- No AIDS-related lymphoma
PATIENT CHARACTERISTICS:
Age
- Adult
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Platelet count > 100,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
Hepatic
- Bilirubin ≤ 2.0 mg/dL
Renal
- Creatinine ≤ 2.0 mg/dL
Other
- HIV negative
- No serious nonmalignant disease that would preclude study participation
- No infection
- No anti-murine antibody reactivity*
- No human anti-mouse antibodies
- Not pregnant
- Negative pregnancy test NOTE: *Results must be available prior to study entry for patients who received prior murine antibodies or proteins, other than rituximab
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Radiotherapy
- No prior stem cell transplantation
- No prior myeloablative therapies with autologous bone marrow transplantation or peripheral blood stem cell rescue
- No prior failed stem cell collection
- More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
- No more than 1 prior chemotherapy regimen
Endocrine therapy
- Not specified
Radiotherapy
- No prior radioimmunotherapy
- No prior whole-brain radiotherapy
- No prior external beam radiotherapy (involved field or regional) to > 25% of active bone marrow
Surgery
- More than 4 weeks since prior major surgery except diagnostic surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells.
PURPOSE: This clinical trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with recurrent primary CNS lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the absorbed radiation doses of CNS lesions after administration of indium In 111 ibritumomab tiuxetan (for imaging) in patients with recurrent primary CNS lymphoma.
Secondary
- Determine the safety of a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan in these patients.
Tertiary
- Determine the radiographic response in patients treated with this drug.
OUTLINE: Patients receive rituximab IV on day 1. Within 4 hours after rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes. Patients then undergo whole body imaging. Patients whose dosimetry indicates that their CNS lesion would receive a sufficient radioimmunotherapy dose receive a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan IV over 20-30 minutes on day 7.
Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
yttrium Y 90 ibritumomab tiuxetanRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetry at 1, 24, and 48 hours
Secondary outcomes (2)
Safety by NCI common toxicty criteria
Radiographic response at 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2004 (estimated)
- Study startDec 2004
- Primary completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Lauren E. Abrey, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082836
- Sponsor's protocol ID
- 04-009
- Other IDs
- MSKCC-04009
- Status last verified
- Jan 2013
- First submitted
- 14 May 2004
- Last updated
- 17 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma
- ClinicalTrials.gov ID
- NCT00082836
- Acronym / sponsor ID
- 04-009
- Conditions
- Lymphoma
- Keywords
- primary central nervous system non-Hodgkin lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2004
- Primary completion
- May 2007 (actual)
- First posted
- 19 May 2004 (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 and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells.
PURPOSE: This clinical trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with recurrent primary CNS lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the absorbed radiation doses of CNS lesions after administration of indium In 111 ibritumomab tiuxetan (for imaging) in patients with recurrent primary CNS lymphoma.
Secondary
- Determine the safety of a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan in these patients.
Tertiary
- Determine the radiographic response in patients treated with this drug.
OUTLINE: Patients receive rituximab IV on day 1. Within 4 hours after rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes. Patients then undergo whole body imaging. Patients whose dosimetry indicates that their CNS lesion would receive a sufficient radioimmunotherapy dose receive a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan IV over 20-30 minutes on day 7.
Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| rituximab | Biological | – |
| yttrium Y 90 ibritumomab tiuxetan | Radiation | – |
Primary outcome
Dosimetry at 1, 24, and 48 hours
2 secondary outcomes
Safety by NCI common toxicty criteria
Radiographic response at 1 and 3 months
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 17 Jan 2013.
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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.
Lauren E. Abrey, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rituximab and yttrium Y 90 ibritumomab tiuxetan in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center 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 17 Jan 2013. 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.
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?
Dosimetry at 1, 24, and 48 hours. 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 17 Jan 2013.