NCT00369291

CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant

CPG 7909 Oligodeoxynucleotides (ODNS) After Autologous Transplantation to Enhance Immune Reconstitution

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Germ Cell Tumor
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
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).
BIOLOGICAL	tetanus toxoid	Tetanus toxoid booster 0.5 ml intramuscularly (IM) in the opposite arm (per MT1999-06)

Timeline

• Start date: 2003-09-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2006-08-29
• Last updated: 2017-11-29

Locations

1 site across 1 country: United States