RATIONALE: Giving CpG 7909 after an autologous stem cell transplant may make a stronger immune response and prevent or delay the recurrence of cancer. PURPOSE: This phase I trial is studying the side effects and best dose of CpG 7909 in treating patients who have undergone autologous stem cell transplant.
OBJECTIVES: Primary * 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. Secondary * 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 MTD. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
KLH is a foreign protein to humans, it will be used to assess the immune response to a neo-antigen given as a single injection, 1 mg subcutaneously in the arm (per MT1999-06).
Tetanus toxoid booster 0.5 ml intramuscularly (IM) in the opposite arm (per MT1999-06)
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Enhanced immune function as measured by response to keyhole limpet hemocyanin and tetanus toxoid
anti-KLH IgG
Time frame: 1 Month after vaccine
Impact of dose escalation of CpG 7909 on primary immune readouts
Compare primary outcome between cohorts
Time frame: At study completion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.