NCT00073931

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

A Phase II Trial Evaluating: Radioiodinated Anti-B1 (Anti-CD20) Antibody With Autologous Stem Cell Transplantation For Relapsed Or Refractory Non-Hodgkin's Lymphoma In Patients 60 Years Of Age And Older

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * Determine the progression-free survival of older patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 tositumomab followed by autologous stem cell transplantation. Secondary * Determine the overall survival of patients treated with this regimen. * Determine the toxicity and tolerability of this regimen in these patients. OUTLINE: * Radioimmunotherapy: Patients receive a test dose of iodine I 131 tositumomab on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over 1 hour on day -14 and are entered into radiation isolation until day -4. * Autologous stem cell transplantation: Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0. Patients undergoing bone marrow transplantation receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning on day 0 and continuing until blood counts recover. Patients are followed at 1, 3, 6, and 12 months and then annually thereafter. PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2 years.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	5 µg/kg/day subcutaneously
BIOLOGICAL	sargramostim	250µg/m2/d subcutaneously
PROCEDURE	autologous bone marrow transplantation	autologous stem cells given via central catheter
PROCEDURE	peripheral blood stem cell transplantation	autologous stem cells given via central catheter
RADIATION	tositumomab and iodine I 131 tositumomab	given intravenously (test dose of 1.7-10 mg/kg tositumomab antibody radiolabeled with \~10 mCi I-131) or via central catheter (therapy dose of 1.7-10 mg/kg tositumomab radiolabeled with individually calculated therapy dose of I-131)

Timeline

• Start date: 1999-10-01
• Primary completion: 2007-05-01
• Completion: 2014-07-01
• First posted: 2003-12-11
• Last updated: 2015-02-05

Locations

1 site across 1 country: United States