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	Sponsor	Protocol IDs
Phase I	Biomarker/Laboratory analysis, Treatment	Closed	18 and over	NCI	UMN-2003LS014 UMN-0302M41542, UMN-MT2003-03, NCT00369291

Objectives

Primary

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.

Secondary

1. 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*
• Hemoglobin ≥ 9 g/dL*
• 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

A total of 25 patients will be accrued for this study.

Outcomes

Enhanced immune function as measured by response to keyhole limpet hemocyanin and tetanus toxoid

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		Ph: 612-624-5109; 888-226-2376 Email: tombl001@umn.edu

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