Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate, tositumomab and iodine i 131 tositumomab
Phase phase 2
Target CD20
Sponsor Southwest Oncology Group
Collaborator National Cancer Institute (NCI)
Start date November 2005
End date November 2013
Trial size 86 participants
Trial identifier NCT00107380, CDR0000415955, S0433, U10CA032102

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 cycles Unlabeled Anti-B1 Antibody 450 mg IV Day 170 Dosimetric dose 35 mg IV Day 170 Unlabeled Anti-B1 Antibody 450 mg IV Day 177 Therapeutic dose 35 mg IV Day 177
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
tositumomab and iodine i 131 tositumomab

Primary Outcomes

Measure
Progression-free Survival at 2 Years
time frame: 0-2 years
Response Rate (Complete, Complete Unconfirmed, and Partial)
time frame: 6 months

Secondary Outcomes

Measure
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
time frame: 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients ≥ Age 60 With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study
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 iodine I 131 tositumomab in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. - Determine the response rate (partial response, complete unconfirmed response, and complete response) in patients treated with this regimen. - Determine the 2-year progression-free survival and response rate (partial response, complete unconfirmed response, and complete response) in B-cell lymphoma 2 (BCL-2) positive patients treated with this regimen. OUTLINE: This is a multicenter study. - Rituximab and chemotherapy: Patients receive R-CHOP comprising rituximab IV over 6 hours; cyclophosphamide IV over 15-45 minutes; doxorubicin IV over 5-20 minutes; and vincristine IV over 5-15 minutes on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo a restaging evaluation. Patients without progressive disease receive CHOP chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone as outlined above. Treatment with CHOP chemotherapy repeats every 21 days for 2 courses. - Radiolabeled monoclonal antibody therapy: Approximately 4-8 weeks after completion of chemotherapy, patients receive tositumomab IV over 1 hour followed by a dosimetric dose of iodine I 131 tositumomab IV over 20 minutes. Patients then undergo gamma scans over a 1-week period in order to determine the correct treatment dose of iodine I 131 tositumomab. No more than 2 weeks after administration of the dosimetric dose, patients receive tositumomab IV over 1 hour followed by a treatment dose of iodine I 131 tositumomab IV over 20 minutes. After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 15 months.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Southwest Oncology Group.