Immunotherapy With Subcutaneous Il-2 and Stem Cell Factor (SCF) for Patients With Lymphoma or Breast Cancer After Autologous Transplantation
OBJECTIVES: I. Determine the safety and maximum tolerated dose of interleukin-2 (IL-2) and
stem cell factor (SCF) following autologous peripheral blood stem cell transplantation in
patients with non-Hodgkin's lymphoma or advanced breast cancer. II. Determine the
effectiveness of filgrastim (G-CSF) and SCF as mobilizing agents in these patients.
OUTLINE: This is a dose escalation study of stem cell factor (SCF). Patients receive
filgrastim (G-CSF) subcutaneously (SC) followed by SCF SC daily for 7-10 days. Beginning on
the fifth day of G-CSF and SCF injections, peripheral blood stem cells (PBSC) are collected
over several days. PBSC are later reinfused and patients receive G-CSF SC daily until
hematopoietic recovery. At least 30 days but no later than 110 days following transplant,
patients who did not experience adverse reactions to SCF during mobilization begin
posttransplant immunotherapy. Patients receive interleukin-2 SC daily and SCF SC 3 times
weekly for 6 weeks. Treatment continues in the absence of unacceptable toxicity or disease
progression. Cohorts of 3-6 patients receive escalating doses of SCF during posttransplant
immunotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting
toxicities. Patients are followed at 1 week, every 3 months for 1 year, and then every 6
months thereafter.
PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study within 1-1.5
years.
Interventional
Primary Purpose: Treatment
Linda J. Burns, MD
Study Chair
Masonic Cancer Center, University of Minnesota
United States: Federal Government
1999LS022
NCT00005993
May 1999
July 2005
Name | Location |
---|