Status:
COMPLETED
S0433 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Treating Older Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Monoclonal antibodies, ...
Detailed Description
OBJECTIVES: * Determine the 2-year progression-free survival of older patients with previously untreated bulky stage II or stage III or IV diffuse large B-cell non-Hodgkin's lymphoma treated with iod...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of diffuse large B-cell non-Hodgkin's lymphoma, meeting 1 of the following stage criteria:
- Bulky stage II disease
- Stage III disease
- Stage IV disease
- Confirmed cluster of differentiation antigen 20 (CD20) antigen-positive disease
- Bidimensionally measurable disease
- Less than 20,000/mcL circulating lymphoid cells on white blood cell (WBC) differential count
- Adequate sections AND a paraffin block OR ≥ 10 unstained sections from the original diagnostic specimen available
- Needle aspiration or cytology are not considered adequate
- No clinical evidence of central nervous system (CNS) involvement by lymphoma
- No prior diagnosis of indolent lymphoma
- No histologic transformation
- PATIENT CHARACTERISTICS:
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- See Disease Characteristics
- Hepatic
- Not specified
- Renal
- Not specified
- Cardiovascular
- Ejection fraction ≥ 45% by multiple gated acquisition scan (MUGA) OR
- No significant abnormalities by echocardiogram
- Pulmonary
- No requirement for continuous supplemental oxygen
- Other
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, stage I or II cancer in complete remission, or carcinoma in situ of the cervix
- No known HIV positivity
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior antibody therapy for lymphoma
- Chemotherapy
- No prior chemotherapy for lymphoma
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior radiotherapy for lymphoma
- Surgery
- No prior solid organ transplantation
- Other
- Concurrent enrollment on protocol SWOG-8947 (lymphoma serum repository) or protocol SWOG-8819 (lymphoma tissue repository) is encouraged
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00107380
Start Date
November 1 2005
End Date
December 1 2015
Last Update
March 7 2016
Active Locations (78)
Enter a location and click search to find clinical trials sorted by distance.
1
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
2
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
3
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
4
Piedmont Hospital
Atlanta, Georgia, United States, 30309