Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 8/29/2018 |
| Start Date: | July 2006 |
| End Date: | October 2009 |
Dose-Response in Radioimmunotherapy of Lymphoma
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.
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.
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.
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.
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
We found this trial at
1
site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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