CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant
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.
|Germ Cell Tumor Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm||Biological: keyhole limpet hemocyanin Biological: tetanus toxoid||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CPG 7909 Oligodeoxynucleotides (ODNS) After Autologous Transplantation to Enhance Immune Reconstitution|
- Enhanced immune function as measured by response to keyhole limpet hemocyanin and tetanus toxoid [ Time Frame: 1 Month after vaccine ]anti-KLH IgG
- Impact of dose escalation of CpG 7909 on primary immune readouts [ Time Frame: At study completion ]Compare primary outcome between cohorts
|Study Start Date:||September 2003|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: CpG 7909
Patients treated with CpG 7909 oligodeoxynucleotides (ODNs) after autologous transplantation to enhance immune reconstitution.
Biological: keyhole limpet hemocyanin
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).
Other Name: KLHBiological: tetanus toxoid
Tetanus toxoid booster 0.5 ml intramuscularly (IM) in the opposite arm (per MT1999-06)
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369291
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Marcie Tomblyn, MD, MS||Masonic Cancer Center, University of Minnesota|