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

NCT00073931 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-02-05

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Ajay K. Gopal, MD · Fred Hutchinson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-10-31
Primary Completion
2007-05-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00073931 on ClinicalTrials.gov