NCT00416312CompletedNot Applicable
Dose-Response in Radioimmunotherapy of Lymphoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 country9 target enrollmentStarted: July 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Tumor Absorbed Dose
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Tumor Absorbed Dose
Time Frame: up to 4 years
tumor absorbed dose (Gy)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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