Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma
Official Title
Dose-Response in Radioimmunotherapy of Lymphoma
Acronym
Not provided
Organization
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
Status Module
Record Verification Date
Jul 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2006
Primary Completion Date
Oct 2009Actual
Completion Date
Oct 2009Actual
First Submitted Date
Dec 27, 2006
First Submission Date that Met QC Criteria
Dec 27, 2006
First Posted Date
Dec 28, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
May 2, 2017
Results First Submitted that Met QC Criteria
Jul 27, 2018
Results First Posted Date
Aug 27, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 27, 2018
Last Update Posted Date
Aug 27, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Conditions Module
Conditions
Lymphoma
Keywords
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
splenic marginal zone lymphoma
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
9Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Conventional & Patient-Specific Dosimetry
Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
Device: Patient-specific dosimetry
Device: conventional dosimetry
Interventions
Name
Type
Description
Arm Group Labels
Other Names
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Tumor Absorbed Dose
tumor absorbed dose (Gy)
up to 4 years
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
100 Years
Standard Ages
AdultOlder Adult
Study Population
All patients treated for NHL by rituximab or zevalin
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
George Sgouros, PhD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore
Maryland
21231-2410
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
All NHL patients treated by either Bexxar or Zevalin
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Conventional & Patient-specific Dosimetry
Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0009 subjects
Conventional Dosimetry
FG0009 subjects
Patient-specific Dosimetry
FG0009 subjects
COMPLETED
FG0007 subjects
NOT COMPLETED
FG0002 subjects
Type
Comment
Reasons
tumors not visible on imaging
FG0002 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Patients being treated for lymphoma using I-131-labeled antibody were imaged and tumor dosimetry was performed using conventional and patient-specific dosimetry. Tumors could not be detected on imaging for 2 of the 9 enrolled patients.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Conventional & Patient-specific Dosimetry
Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Tumors could not be detected on imaging for 2 of the 9 enrolled patients
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Tumor Absorbed Dose
tumor absorbed dose (Gy)
Posted
Mean
Standard Deviation
Gy
up to 4 years
tumor
tumor
ID
Title
Description
OG000
Conventional & Patient-specific Dosimetry
Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
Units
Counts
Participants
OG000
Adverse Events Module
Frequency Threshold
0
Time Frame
Not provided
Description
Adverse event data was not collected since this was a data collection study tacked on to routine patient treatment
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Conventional & Patient-specific Dosimetry
Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
Serious Adverse Events
Not provided
Other Adverse Events
Not provided
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
George Sgouros, Ph.D.
Johns Hopkins University, School of Medicine
410 614 0116
gsgouros@jhmi.edu
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D008223
Lymphoma
D018442
Lymphoma, B-Cell, Marginal Zone
D002051
Burkitt Lymphoma
D016403
Lymphoma, Large B-Cell, Diffuse
D008228
Lymphoma, Non-Hodgkin
D016400
Lymphoma, Large-Cell, Immunoblastic
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D008224
Lymphoma, Follicular
D020522
Lymphoma, Mantle-Cell
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
D008258
Waldenstrom Macroglobulinemia
D054391
Lymphoma, Extranodal NK-T-Cell
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
Waldenström macroglobulinemia
contiguous stage II adult Burkitt lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult lymphoblastic lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II mantle cell lymphoma
contiguous stage II marginal zone lymphoma
contiguous stage II small lymphocytic lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II marginal zone lymphoma
noncontiguous stage II small lymphocytic lymphoma
stage I adult Burkitt lymphoma
stage I adult diffuse large cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage I adult lymphoblastic lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage I mantle cell lymphoma
stage I marginal zone lymphoma
stage I small lymphocytic lymphoma
adult grade III lymphomatoid granulomatosis
recurrent adult grade III lymphomatoid granulomatosis
primary central nervous system non-Hodgkin lymphoma
adult nasal type extranodal NK/T-cell lymphoma
Not provided
Intervention Model Description
Not provided
Primary Purpose
Not provided
Observational Model
Cohort
Time Perspective
Prospective
Masking Info
No data available
No data is available for this block.
Conventional & Patient-Specific Dosimetry
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.
Conventional & Patient-Specific Dosimetry
9
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0007
Title
Measurements
<=18 years
BG0000
Between 18 and 65 years
BG0001
>=65 years
BG0006
Sex: Female, Male
Tumors could not be detected on imaging for 2 of the 9 enrolled patients