Phase 2
N=86
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
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00107380 ↗Enrolled (actual)
86
Serious AEs
9.5%
Results posted
Feb 2014
Primary outcome: Primary: Progression-free Survival (PFS) at 2 Years — 69 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Biological); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); prednisone (Drug); vincristine sulfate (Drug); tositumomab and iodine I 131 tositumomab (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) at 2 Years |
69 | — |
| PRIMARY Response Rate (Complete, Complete Unconfirmed, and Partial) |
21; 41; 10; 12 | — |
| SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
2; 1; 1; 3; 1; 1 | — |
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, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving a radiolabeled monoclonal antibody together with rituximab and combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving iodine I 131 tositumomab together with rituximab and combination chemotherapy works in treating older patients with stage II, stage III, or stage IV B-cell non-Hodgkin's lymphoma.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00107380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.