CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT00369291|
Recruitment Status : Terminated (Slow accrual)
First Posted : August 29, 2006
Last Update Posted : November 29, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Germ Cell Tumor Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm||Biological: keyhole limpet hemocyanin Biological: tetanus toxoid||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CPG 7909 Oligodeoxynucleotides (ODNS) After Autologous Transplantation to Enhance Immune Reconstitution|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
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: KLH
Biological: tetanus toxoid
Tetanus toxoid booster 0.5 ml intramuscularly (IM) in the opposite arm (per MT1999-06)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|