Non-Hodgkin's LymphomaNCT00387023
Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma
A study testing Rituximab and Zevalin in people with Non-Hodgkin's Lymphoma and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To evaluate the efficacy of Zevalin for the treatment of low-grade follicular Non-Hodgkin's lymphoma of the orbit or mucosa-associated lymphoid tissue (MALT) of conjunctiva using radiographic imaging, clinical examination (slit lamp biomicroscopy and external examination of the conjunctiva), and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Lymphoma
- What is being tested?
- Rituximab and Zevalin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Biopsy-proven diagnosis of low-grade Non-Hodgkin's follicular lymphoma of the orbit or MALT of the conjunctiva/orbit. The orbit/conjunctiva has to be the primary or predominant site of involvement or if there is a previous history of systemic involvement, the orbit/conjunctiva should be the only site of new recurrence.
- No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy
- An Institutional Review Board (IRB)-approved signed informed consent
- Age >18 years. This is justified since low-grade non-Hodgkin's lymphoma of the orbit is extremely rare to non-existent in the pediatric population
- Expected survival of >3 months
- Pre-study performance status of 0, 1, or 2 according to the WHO
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- Acceptable hematologic status within two weeks prior to patient registration, including: a) Absolute neutrophil count ([segmented neutrophils + bands] x total WBC)> 1500/mm3 b) Total lymphocyte count < 5,000/mm3 for patients with small lymphocytic lymphoma (IWFA) c) Platelet counts> 150,000/mm3, these patients will receive a dose of 0.4 mCi/kg of Zevalin d) Platelet counts from 100,00/mm3 to 149,000/mm3, these patients will receive a 0.3mCi/kg dose of Zevalin
- Female patients who are not pregnant or lactating
- Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method)
- Patients previously on Phase II drugs are eligible if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post treatment toxicities observed
- Patients determined to have less than 25% bone marrow involvement with lymphoma within six weeks of registration (based on a bone marrow biopsy). (This criteria must be strictly met for adequate patient safety.)
Who cannot join
- Patients with impaired bone marrow reserve, as indicated by one or more of the following: a) Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue b) Platelet count < than 100,000 cells/mm3 c) Hypocellular bone marrow (less than 15% cellularity) d) Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid)
- Prior radioimmunotherapy
- Presence of central nervous system (CNS) lymphoma
- Patients with HIV or AIDS-related lymphoma
- Patients with small lymphocytic lymphoma (IWF A) - who have a total lymphocyte count > 5,000/mm3
- Patients with pleural effusion
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- Patients with abnormal liver function: total bilirubin > 2.0 mg/dL
- Patients with abnormal renal function: serum creatinine > 2.0 mg/dL
- Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional)
- Patients who have received Granulocyte colony-stimulating factor (G-CSF or GM-CSF) therapy within two weeks prior to treatment
- Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives
- Major surgery, other than diagnostic surgery, within four weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial of Radioimmunotherapy With Yttrium 90-Labeled (90Y) Zevalin for Low-Grade Follicular Non-Hodgkin's Lymphoma or MALT of the Orbit/Conjunctiva
Primary Objectives:
- To evaluate the efficacy of Zevalin for the treatment of low-grade follicular Non-Hodgkin's lymphoma of the orbit or mucosa-associated lymphoid tissue (MALT) of conjunctiva using radiographic imaging, clinical examination (slit lamp biomicroscopy and external examination of the conjunctiva), and external photography whenever possible.
- To establish the safety profile in this patient population using clinical examination including slit lamp biomicroscopy, and evaluation of the tear film with Schirmer's test.
- To establish the dosimetry for Zevalin in the orbit in the first 3 patients who agree to undergo dosimetry.
Read the detailed description
Rituximab and Zevalin are monoclonal antibodies that bind to lymphoma cells and cause cell death.
As is the case for all patients with orbital lymphoma, an orbital biopsy must be performed to confirm the diagnosis and status of the orbital lymphoma. The study doctors must first make sure that the disease has not spread too much and is not severe enough to require immediate treatment with chemotherapy before you can begin treatment on this study. You will have about 4 teaspoons of blood drawn. Women who are able to have children must have a negative blood or urine pregnancy test.
You will receive two injections of rituximab by vein over about 4 to 6 hours. This is followed by an infusion of Zevalin over about 30 minutes on the same day. Whole body images will be performed immediately and at 4-6, 24, 72, and 144 hours after receiving Zevalin. About 1 week later, you will receive a second infusion of rituximab and Zevalin.
You may be taken off the study if your orbital lymphoma does not respond within three months of receiving rituximab and Zevalin. Researchers will measure your response to therapy using magnetic Resonance imaging (MRI) of the orbit and an evaluation of the eye in the clinic. If you are taken off study, you will be given the option of receiving external beam radiation therapy as treatment for the disease.
Follow-up evaluations will be done every 3 months for 2 years and every 6 months for Years 3 and 4. This testing is considered standard of care and would include medical history, physical exam, blood tests, and urine tests. The status of the disease will be evaluated using CT scan or MRI of the orbit every 3 months for the first year and every 6 months for Years 2, 3, and 4. Blood tests (about 4 teaspoons each) will be every 3 months for the first year and may be continues every 3 to 6 month until they become negative or you start another anti-cancer therapy.
This is an investigational study. Zevalin and rituximab are both FDA approved but their use together in this study is investigational. A total of up to 12 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center.
- Conditions
- Non-Hodgkin's Lymphoma, Lymphoma
- Being tested
- Rituximab, Zevalin
- Keywords
- Non-Hodgkin's Lymphoma, Orbital Lymphoma, Rituximab, Rituxan, Zevalin, Ibritumomab tiuxetan, IDEC-Y2B8, Eye
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Orbital lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
250 mg/m^2 IV over 4-6 hours for 2 weeks.
ZevalinDrug
Also called Ibritumomab tiuxetan, IDEC-Y2B8
5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Zevalin + Rituximab | Experimental | Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 millicurie (mCi)/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week. Receives: Drug: Rituximab; Drug: Zevalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Response (CR) or Partial Response (PR)
Tumor response to therapy measured by tumor size as measured radiographically at baseline and at three months from baseline. Tumor response classified as complete response (CR) or partial response (PR), or stable disease (SD), or progressive disease (PD) using International Workshop Standardized Response Criteria (IWC) for Non-Hodgkin's Lymphomas. If the orbital/ocular adnexal lymphoma was not evaluable radiographically, clinical evaluation using slit lamp biomicroscopy was used to assess PR or CR.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startFeb 2004
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Bita Esmaeli, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387023
- Sponsor's protocol ID
- 2003-0696
- Status last verified
- Sep 2013
- First submitted
- 10 Oct 2006
- Last updated
- 18 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Radioimmunotherapy With Yttrium 90-Labeled (90Y) Zevalin for Low-Grade Follicular Non-Hodgkin's Lymphoma or MALT of the Orbit/Conjunctiva
- ClinicalTrials.gov ID
- NCT00387023
- Acronym / sponsor ID
- 2003-0696
- Conditions
- Non-Hodgkin's Lymphoma, Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Orbital Lymphoma, Rituximab, Rituxan, Zevalin, Ibritumomab tiuxetan, IDEC-Y2B8, Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Feb 2004
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Oct 2006 (estimated)
- Results
- Posted 18 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To evaluate the efficacy of Zevalin for the treatment of low-grade follicular Non-Hodgkin's lymphoma of the orbit or mucosa-associated lymphoid tissue (MALT) of conjunctiva using radiographic imaging, clinical examination (slit lamp biomicroscopy and external examination of the conjunctiva), and external photography whenever possible.
- To establish the safety profile in this patient population using clinical examination including slit lamp biomicroscopy, and evaluation of the tear film with Schirmer's test.
- To establish the dosimetry for Zevalin in the orbit in the first 3 patients who agree to undergo dosimetry.
Detailed description
Rituximab and Zevalin are monoclonal antibodies that bind to lymphoma cells and cause cell death.
As is the case for all patients with orbital lymphoma, an orbital biopsy must be performed to confirm the diagnosis and status of the orbital lymphoma. The study doctors must first make sure that the disease has not spread too much and is not severe enough to require immediate treatment with chemotherapy before you can begin treatment on this study. You will have about 4 teaspoons of blood drawn. Women who are able to have children must have a negative blood or urine pregnancy test.
You will receive two injections of rituximab by vein over about 4 to 6 hours. This is followed by an infusion of Zevalin over about 30 minutes on the same day. Whole body images will be performed immediately and at 4-6, 24, 72, and 144 hours after receiving Zevalin. About 1 week later, you will receive a second infusion of rituximab and Zevalin.
You may be taken off the study if your orbital lymphoma does not respond within three months of receiving rituximab and Zevalin. Researchers will measure your response to therapy using magnetic Resonance imaging (MRI) of the orbit and an evaluation of the eye in the clinic. If you are taken off study, you will be given the option of receiving external beam radiation therapy as treatment for the disease.
Follow-up evaluations will be done every 3 months for 2 years and every 6 months for Years 3 and 4. This testing is considered standard of care and would include medical history, physical exam, blood tests, and urine tests. The status of the disease will be evaluated using CT scan or MRI of the orbit every 3 months for the first year and every 6 months for Years 2, 3, and 4. Blood tests (about 4 teaspoons each) will be every 3 months for the first year and may be continues every 3 to 6 month until they become negative or you start another anti-cancer therapy.
This is an investigational study. Zevalin and rituximab are both FDA approved but their use together in this study is investigational. A total of up to 12 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zevalin + Rituximab | Experimental | Drug: Rituximab, Drug: ZevalinRituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 millicurie (mCi)/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Biopsy-proven diagnosis of low-grade Non-Hodgkin's follicular lymphoma of the orbit or MALT of the conjunctiva/orbit. The orbit/conjunctiva has to be the primary or predominant site of involvement or if there is a previous history of systemic involvement, the orbit/conjunctiva should be the only site of new recurrence.
- No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy
- An Institutional Review Board (IRB)-approved signed informed consent
- Age >18 years. This is justified since low-grade non-Hodgkin's lymphoma of the orbit is extremely rare to non-existent in the pediatric population
- Expected survival of >3 months
Key exclusion criteria (12 listed)
- Patients with impaired bone marrow reserve, as indicated by one or more of the following: a) Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue b) Platelet count < than 100,000 cells/mm3 c) Hypocellular bone marrow (less than 15% cellularity) d) Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid)
- Prior radioimmunotherapy
- Presence of central nervous system (CNS) lymphoma
- Patients with HIV or AIDS-related lymphoma
- Patients with small lymphocytic lymphoma (IWF A) - who have a total lymphocyte count > 5,000/mm3
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 |
|---|---|---|
| RituximabAlso: Rituxan250 mg/m^2 IV over 4-6 hours for 2 weeks. | Drug | Zevalin + Rituximab |
| ZevalinAlso: Ibritumomab tiuxetan, IDEC-Y2B85 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week. | Drug | Zevalin + Rituximab |
Primary outcome
Number of Participants With Complete Response (CR) or Partial Response (PR)
Time frame: 3 months
Tumor response to therapy measured by tumor size as measured radiographically at baseline and at three months from baseline. Tumor response classified as complete response (CR) or partial response (PR), or stable disease (SD), or progressive disease (PD) using International Workshop Standardized Response Criteria (IWC) for Non-Hodgkin's Lymphomas. If the orbital/ocular adnexal lymphoma was not evaluable radiographically, clinical evaluation using slit lamp biomicroscopy was used to assess PR or CR.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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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.
Bita Esmaeli, MD principal investigator
M.D. Anderson 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 Zevalin in people with Non-Hodgkin's Lymphoma and Lymphoma, run by M.D. Anderson 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?
The sponsor lists 11 inclusion and 12 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: finished, as of the sponsor's last update on 18 Nov 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?
Yes. Results are posted in the registry (first posted 18 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Complete Response (CR) or Partial Response (PR) (time frame: 3 months). 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 18 Nov 2013.