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NCT00416312 · REGISTRY CONDITION SEARCH

Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
Not reported
Status at capture
COMPLETED
Registry last update
2018-08-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Tumor Absorbed Dose

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
100 Years
minimum Age
18 Years
sampling Method
NON_PROBABILITY_SAMPLE
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
study Population
All patients treated for NHL by rituximab or zevalin
Treatment arms and interventions
arm Groups
  1. description
    Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
    intervention Names
    1. Device: Patient-specific dosimetry
    2. Device: conventional dosimetry
    label
    Conventional & Patient-Specific Dosimetry
interventions
  1. arm Group Labels
    1. Conventional & Patient-Specific Dosimetry
    description
    Tumor absorbed dose calculation using patient-specific 3D-RD dosimetry software. 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.
    name
    Patient-specific dosimetry
    type
    DEVICE
  2. arm Group Labels
    1. Conventional & Patient-Specific Dosimetry
    description
    Doses calculated using conventional dosimetry software. 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.
    name
    conventional dosimetry
    type
    DEVICE
Study design
observational Model
COHORT
time Perspective
PROSPECTIVE
Enrollment
count
9
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    tumor absorbed dose (Gy)
    measure
    Tumor Absorbed Dose
    time Frame
    up to 4 years
Full study description
brief Summary
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.
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.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice