Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma
This study has been completed.
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00416312
First received: December 27, 2006
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab and yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan works in treating patients with non-Hodgkin's lymphoma.
| Condition | Intervention |
|---|---|
|
Lymphoma |
Biological: rituximab Device: computed tomography Procedure: positron emission tomography Procedure: radionuclide imaging Procedure: single photon emission computed tomography Radiation: tositumomab and iodine I 131 tositumomab Radiation: yttrium Y 90 ibritumomab tiuxetan |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Dose-Response in Radioimmunotherapy of Lymphoma |
Resource links provided by NLM:
Drug Information available for:
Yttrium
Iodine
Sodium iodide I 131
Iodide
Rituximab
Tositumomab
Ibritumomab tiuxetan
U.S. FDA Resources
Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:
Primary Outcome Measures:
- Relationship between estimated absorbed dose and tumor response using different dosimetric methodologies [ Time Frame: July '06 to Sept '10 ] [ Designated as safety issue: No ]
- Relationship between estimated absorbed dose and normal organ toxicity using different dosimetric methodologies [ Time Frame: July '06 to Sept '10 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Difference in the dose-response relationship between dosimetric methodologies [ Time Frame: July '06 to Sept '10 ] [ Designated as safety issue: No ]
- Influence of prior therapy on the dose-response relationship for hematologic toxicity [ Time Frame: July '06 to Sept '10 ] [ Designated as safety issue: Yes ]
| Enrollment: | 9 |
| Study Start Date: | July 2006 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Stratum 1
Patients receive dosimetric rituximab IV followed by indium In 111 (^111In) ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT scans between 2-24, 48-72, and 90-120 hours after ^111In ibritumomab tiuxetan administration. Patients who have acceptable biodistribution receive therapeutic rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between days 7-9.
|
Biological: rituximab Device: computed tomography Procedure: positron emission tomography Procedure: radionuclide imaging Procedure: single photon emission computed tomography Radiation: yttrium Y 90 ibritumomab tiuxetan |
|
Experimental: Stratum 2
Patients receive dosimetric tositumomab IV over 60 minutes followed by iodine I 131 (^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT scans and SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable biodistribution receive therapeutic tositumomab IV over 60 minutes followed by ^131I tositumomab IV over 20 minutes on approximately day 7.
|
Device: computed tomography Procedure: positron emission tomography Procedure: radionuclide imaging Procedure: single photon emission computed tomography Radiation: tositumomab and iodine I 131 tositumomab |
Detailed Description:
OBJECTIVES:
Primary
- Determine the relationship between estimated absorbed dose and tumor response using different dosimetric methodologies in patients with non-Hodgkin's lymphoma treated with iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan.
- Determine the relationship between estimated absorbed dose and normal organ toxicity using different dosimetric methodologies in these patients.
Secondary
- Assess the difference in the dose-response relationship between dosimetric methodologies in these patients.
- Assess the influence of prior therapy on the dose-response relationship for hematologic toxicity in these patients.
OUTLINE: Patients are stratified according to planned radioimmunotherapy treatment (iodine I 131 tositumomab vs yttrium Y 90 ibritumomab tiuxetan).
- Stratum 1: Patients receive dosimetric rituximab IV followed by indium In 111 (^111In) ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT scans between 2-24, 48-72, and 90-120 hours after ^111In ibritumomab tiuxetan administration. Patients who have acceptable biodistribution receive therapeutic rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between days 7-9.
- Stratum 2: Patients receive dosimetric tositumomab IV over 60 minutes followed by iodine I 131 (^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT scans and SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable biodistribution receive therapeutic tositumomab IV over 60 minutes followed by ^131I tositumomab IV over 20 minutes on approximately day 7.
In both strata, blood is collected at baseline to measure FLT-3 levels. All patients also undergo a baseline PET/CT scan.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of non-Hodgkin's lymphoma
- Measurable disease by CT scan or nuclear medicine imaging
- Eligible, by standard of care criteria, for iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan treatment
PATIENT CHARACTERISTICS:
- No other malignancy within the past 3 years except basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No alcoholism or drug abuse within the past 2 years
- No severe emotional, behavioral, or psychiatric problems that would limit study compliance
PRIOR CONCURRENT THERAPY:
- No concurrent participation in another investigational drug study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416312
Locations
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
| Principal Investigator: | George Sgouros, PhD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00416312 History of Changes |
| Other Study ID Numbers: | JHOC-J0636, CDR0000522705 |
| Study First Received: | December 27, 2006 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse small cleaved 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 mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma splenic marginal zone lymphoma |
stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma stage III marginal zone lymphoma stage III small lymphocytic lymphoma stage IV adult Burkitt lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse small cleaved cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Iodine Cadexomer iodine Rituximab Antibodies, Monoclonal |
Iodine-131 anti-B1 antibody Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Immunologic Factors Antirheumatic Agents Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013