TheranosticTrials.org

Clinical Trial · NCT00107380

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

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Richard I. Fisher, MD (STUDY_DIRECTOR)

Jonathan W. Friedberg, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT00107380

Drug / Compound

tositumomab

Isotope(s):
Target(s):
  • CD20 antigen
Ligand Class: Antibodies

Eligibility

Inclusion

  • Bidimensionally measurable disease
  • Adequate sections AND a paraffin block OR ≥ 10 unstained sections from the original diagnostic specimen available
  • Ejection fraction ≥ 45% by multiple gated acquisition scan (MUGA) OR
  • Stage IV disease
  • Diagnosis of diffuse large B-cell non-Hodgkin's lymphoma, meeting 1 of the following stage criteria:
  • Concurrent enrollment on protocol SWOG-8947 (lymphoma serum repository) or protocol SWOG-8819 (lymphoma tissue repository) is encouraged
  • Needle aspiration or cytology are not considered adequate
  • Zubrod 0-2Life expectancy
  • Stage III disease
  • Less than 20,000/mcL circulating lymphoid cells on white blood cell (WBC) differential count
  • Bulky stage II disease
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • Confirmed cluster of differentiation antigen 20 (CD20) antigen-positive disease

Exclusion

  • No clinical evidence of central nervous system (CNS) involvement by lymphoma
  • No prior diagnosis of indolent lymphoma
  • No known HIV positivityBiologic therapy
  • No prior radiotherapy for lymphomaSurgery
  • Not specifiedRenal
  • No histologic transformationPerformance status
  • No prior chemotherapy for lymphomaEndocrine therapy
  • No prior solid organ transplantationOther
  • Not specifiedRadiotherapy
  • No prior antibody therapy for lymphomaChemotherapy
  • No requirement for continuous supplemental oxygenOther
  • Not specifiedHematopoietic
  • Not specifiedCardiovascular
  • No significant abnormalities by echocardiogramPulmonary