Clinical Trials Directory

Trials / Completed

CompletedNCT00017381

Monoclonal Antibody Therapy and Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma

Dose Finding Study of IDEC-Y2B8 With Autologous Stem Cell Support

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This phase I trial is studying how well monoclonal antibody therapy with peripheral stem cell transplant works in treating patients with non-Hodgkin's lymphoma. 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. Peripheral stem cell transplant may allow the doctor to give higher doses of monoclonal antibodies and kill more cancer cells

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of IDEC-Y2B8 when administered with rituximab in vivo purging and autologous stem cell rescue. II. To obtain correlative laboratory data of in vivo purging with rituximab in patients with 0-35% marrow involvement. OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8). PART I: Patients receive rituximab IV on days 1, 8, 15, and 22 and cyclophosphamide IV over 1 hour on day 25. Filgrastim (G-CSF) is administered subcutaneously (SC) daily beginning on day 26 and continuing until autologous peripheral blood stem cells (PBSC) are harvested. PART II: Beginning 4-6 weeks after completion of the fourth rituximab infusion, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 followed by dosimetry imaging on days 1, 2, 4, and 7. Patients then receive IDEC-Y2B8 IV over 10 minutes once between days 8-15. The initial 3 patients receive the same dose of IDEC-Y2B8 and then subsequent cohorts of 3-5 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose is determined. PART III: All patients undergo PBSC transplantation (PBSCT) beginning after residual bone marrow radioactivity resolves. G-CSF is administered SC beginning 1 day after PBSCT and continuing until blood counts recover. Patients are followed every 3 months for 1 year and then every 6 months thereafter.

Conditions

Interventions

TypeNameDescription
BIOLOGICALrituximabGiven IV
DRUGcyclophosphamideGiven IV
BIOLOGICALfilgrastimGiven SC
RADIATIONyttrium Y 90 ibritumomab tiuxetanGiven IV
PROCEDUREperipheral blood stem cell transplantationUndergo PBSCT

Timeline

Start date
2001-04-01
Primary completion
2007-12-01
First posted
2003-01-27
Last updated
2013-01-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00017381. Inclusion in this directory is not an endorsement.