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

Recruiting in Palo Alto (17 mi)

+77 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: SWOG Cancer Research Network

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jonathan W. Friedberg, MD

Principal Investigator

James P. Wilmot Cancer Center

Richard I. Fisher, MD

Principal Investigator

James P. Wilmot Cancer Center

Eligibility Criteria

Inclusion Criteria

Bulky stage II disease

Stage III disease

Stage IV disease

See 7 more

Treatment Details

Interventions

Cyclophosphamide (Alkylating agents)
Doxorubicin Hydrochloride (Antitumor Antibiotic)
Iodine I 131 Tositumomab (Radiopharmaceuticals)
Prednisone (Corticosteroid)
Rituximab (Monoclonal Antibodies)
Vincristine Sulfate (Vinca Alkaloids)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: R-CHOP x 8 with I-131 TositumomabExperimental Treatment6 Interventions

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

Cyclophosphamide is already approved in Canada, Japan for the following indications: