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Phase I Study of CpG 7909 For the Enhancement of Immune Reconstitution in Patients Who Have Undergone Autologous Stem Cell Transplantation
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase I | Biomarker/Laboratory analysis, Treatment | Closed | 18 and over | UMN-2003LS014 UMN-0302M41542, UMN-MT2003-03, NCT00369291 |
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.
Entry Criteria Disease Characteristics:
- Must have undergone autologous stem cell transplantation for non-Hodgkin's lymphoma, Hodgkin’s lymphoma, acute myeloid leukemia, multiple myeloma, or germ cell tumor
- Must have engraftment and be independent of transfusion support or growth factor support
- Must have undergone transplantation within the past 60-74 days
- Must be eligible for and consent to participate in clinical trial MT1999-06 "Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen Specific Immune Responses" (BB-IND10430)
Prior/Concurrent Therapy:
- See Disease Characteristics
- At least 1 week since prior hematopoietic growth factors
- At least 1 week since prior platelet or red blood cell transfusions
- At least 30 days since prior cytotoxic therapy
- No other concurrent post-transplant investigational agents
- No concurrent systemic corticosteroids or other immunosuppressant
- No concurrent therapeutic antibiotics
- Prophylactic antiobiotics allowed
- No concurrent IV hyperalimentation or IV fluids
- No concurrent radiotherapy, growth factor therapy, or steroid therapy
- All prior post-transplant radiotherapy must be completed prior to study
Patient Characteristics:
- CALGB performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Platelet count ≥ 50,000/mm³*
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Hemoglobin ≥ 9 g/dL*
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Absolute neutrophil count ≥ 1,000/mm³*
- Absolute lymphocyte count ≥ 500/mm³*
- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min
- Bilirubin ≤ 2 times normal
- ALT ≤ 2 times normal
- Must be afebrile (≤ 38.2° C)
- No evidence of active infection
- No significant nonmalignant disease, including any of the following:
- HIV infection
- Uncontrolled hypertension (diastolic blood pressure > 115 mm Hg)
- Unstable angina
- New York Heart Association class II congestive heart failure
- Poorly controlled diabetes
- Coronary angioplasty within the past 6 months
- Myocardial infarction within the past 6 months
- Uncontrolled atrial or ventricular cardiac arrhythmias
- No history of autoimmune diseases
- Controlled thyroid disease allowed
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
[Note: *Tranfusion and growth factor independent] Expected Enrollment 25A total of 25 patients will be accrued for this study. Outcomes Primary Outcome(s)Enhanced immune function as measured by response to keyhole limpet hemocyanin and tetanus toxoid
Secondary Outcome(s)Impact of dose escalation of CpG 7909 on 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.
Trial Contact Information
Trial Lead Organizations Masonic Cancer Center at University of Minnesota | | | Marcie Tomblyn, MD, MS, Principal investigator | | | |
Registry Information | | Official Title | | CPG 7909 Oligodeoxynucleotides (ODNS) After Autologous Transplantation to Enhance Immune Reconstitution | | Trial Start Date | | 2003-09-01 | | Trial Completion Date | | 2008-08-31 (estimated) | | Registered in ClinicalTrials.gov | | NCT00369291 | | Date Submitted to PDQ | | 2006-06-09 | | Information Last Verified | | 2009-05-01 | | NCI Grant/Contract Number | | CA77598 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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