Status:
COMPLETED
S0801 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ 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: * To evaluate the response rate in patients with previously untreated stage II-IV follicular non-Hodgkin lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride, vinc...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed\* grade 1, 2, or 3 follicular B-cell non-Hodgkin lymphoma meeting the following criteria:
- Bulky stage II or stage III or IV disease
- Diffuse large cell component must be \< 25% of the biopsy
- Confirmed cluster of differentiation antigen 20 (CD20) antigen-positive disease NOTE: \*Needle aspiration or cytology are not considered adequate for pathology review
- Patient must have unilateral or bilateral bone marrow aspirate and biopsy performed within 42 days
- Positive biopsy performed \> 42 days but \< 6 months allowed
- Previously untreated disease
- Bidimensionally measurable disease
- No clinical evidence of central nervous system (CNS) involvement by lymphoma
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Cardiac ejection fraction ≥ 45% by multigated acquisition scan (MUGA) or ECHO
- No significant cardiac abnormalities
- No known HIV positivity
- No requirement for continuous supplemental oxygen therapy
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently in complete remission
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 12 months after completion of maintenance therapy
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
- No prior solid organ transplantation
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00770224
Start Date
April 1 2009
End Date
August 1 2019
Last Update
August 28 2019
Active Locations (114)
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1
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States, 36608
2
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
3
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
4
Cancer Care Center of Decatur
Decatur, Illinois, United States, 62526