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

This study has been completed.
Sponsor:
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

December 27, 2006
May 15, 2013
July 2006
October 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Relationship between estimated absorbed dose and tumor response using different dosimetric methodologies
  • Relationship between estimated absorbed dose and normal organ toxicity using different dosimetric methodologies
Complete list of historical versions of study NCT00416312 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Difference in the dose-response relationship between dosimetric methodologies
  • Influence of prior therapy on the dose-response relationship for hematologic toxicity
Not Provided
Not Provided
 
Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Device: computed tomography
    • Procedure: positron emission tomography
    • Procedure: radionuclide imaging
    • Procedure: single photon emission computed tomography
    • Radiation: tositumomab and iodine I 131 tositumomab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00416312
JHOC-J0636, CDR0000522705
Not Provided
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: George Sgouros, PhD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP