TheranosticTrials.org

Clinical Trial · NCT00073931

Iodine I 131 Tositumomab Followed by Autologous Stem Cell Transplantation in Treating Older Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Overview

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Combining a radiolabeled monoclonal antibody with autologous stem cell transplantation may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with autologous stem cell transplantation in treating older patients who have relapsed or refractory non-Hodgkin's lymphoma.

Sponsor

Fred Hutchinson Cancer Center

Phase

Phase 2

Contacts

Ajay K. Gopal, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT00073931

Drug / Compound

tositumomab

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies

Eligibility

Inclusion

  • Autologous hematopoietic stem cells or bone marrow harvested and cryopreserved
  • HIV negative
  • More than 60 daysHematopoietic
  • Vital capacity at least 70% of expectedOther
  • 10% or less marrow involvement by flow cytometry or morphology if purged bone marrow is to be used
  • Failed at least 1 prior standard systemic therapy
  • CD20+ disease
  • Creatinine less than 2.0 mg/dLCardiovascular
  • Negative pregnancy test
  • Tumor burden less than 500 cc by computed tomography or MRI
  • Persistent lymphoma by physical examination, radiographic studies, bone marrow evaluations, flow cytometry, or polymerase chain reaction
  • Bilirubin less than 1.5 mg/dLRenal
  • More than 30 days since prior systemic antilymphoma therapy
  • SWOG 0-1Life expectancy
  • Histologically confirmed non-Hodgkin's lymphoma
  • Fertile patients must use effective contraception
  • 60 to 80Performance status
  • Able to perform self-care during radiation isolation
  • FEV\_1 at least 70% of expected

Exclusion

  • No splenomegaly
  • No competing causes of death that would predict life span to be less than 10 additional yearsBiologic therapy
  • Not pregnant
  • No major infection
  • No CNS lymphoma
  • No other serious medical condition considered to represent contraindications to bone marrow transplantation
  • No prior bone marrow or stem cell transplantationChemotherapy
  • No major organ dysfunction
  • No circulating anti-mouse antibody
  • Not specifiedRadiotherapy
  • Not specifiedOther
  • No prior radiotherapy greater than 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, or more than 25% of red marrow)Surgery
  • Not specifiedEndocrine therapy
  • No active coronary artery diseasePulmonary
  • No circulating lymphoma cells by morphology or flow cytometry at or near the time of peripheral blood stem cell (PBSC) collection if unpurged PBSCs are to be used