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Completed

NCT Number: NCT00416312

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-specific dosimetry

Device

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.

conventional dosimetry

Device

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.

Primary outcomes

  1. Tumor Absorbed Dose

    Time frame: up to 4 years

    tumor absorbed dose (Gy)

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Dose-Response in Radioimmunotherapy of Lymphoma

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 28, 2006
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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