CPG 7909 Oligodeoxynucleotides (ODNS) After Autologous Transplantation to Enhance Immune Reconstitution
- Determine whether CpG 7909 enhances immune function, as measured by the response to
keyhole limpet hemocyanin (neo-antigen) and tetanus toxoid (memory antigen), in
patients who have undergone autologous stem cell transplantation.
- Determine if dose escalation of CpG 7909, within a range of previously tested safe
doses of CpG 7909, impacts upon the primary immune readouts.
OUTLINE: This is a non-randomized, dose-escalation study of CpG 7909.
Patients receive CpG 7909 subcutaneously (SC) on days 1, 7, and 14. Patients receive keyhole
limpet hemocyanin SC and tetanus toxoid SC on day 7.
Cohorts of 3-6 patients receive escalating doses of Cp6 7909 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 toxicity. A total of 10 patients are treated at the
Blood is collected at baseline and at approximately day 40 for immunological studies,
including immunoenzyme techniques, antibody response assays, and immunophenotyping.
After completion of study treatment, patients are followed every 3 months for 1 year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Enhanced immune function as measured by response to keyhole limpet hemocyanin and tetanus toxoid
1 Month after vaccine
Marcie Tomblyn, MD, MS
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|