COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00369291
Recruitment Status : Terminated (Slow accrual)
First Posted : August 29, 2006
Last Update Posted : November 29, 2017
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief 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.

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

Detailed Description:



  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tetanus

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Enhanced immune function as measured by response to keyhole limpet hemocyanin and tetanus toxoid [ Time Frame: 1 Month after vaccine ]
    anti-KLH IgG

Secondary Outcome Measures :
  1. Impact of dose escalation of CpG 7909 on primary immune readouts [ Time Frame: At study completion ]
    Compare primary outcome between cohorts

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have undergone autologous transplantation for non-Hodgkin's lymphoma (NHL), Hodgkin's disease, acute myelogenous leukemia (AML), germ cell tumors, or multiple myeloma.
  • Patients must be eligible for and consent to participate in study MT1999 06 - Vaccination with tetanus toxoid and Keyhole Limpet Hemocyanin (KLH) to assess antigen specific immune responses (BB-IND 10430).
  • Patients will be eligible to receive CpG 7909 and vaccines on or after day 60 post transplant. No patients are eligible for this protocol beyond day 74 post transplant. Therefore, all patients will start therapy on this protocol between days 60-74 post transplant to allow for patient scheduling flexibility.
  • Patients must have engraftment and be independent of transfusion support or growth factor support.
  • Patients must not have received platelet or red-cell transfusions in the previous week.
  • Patients must have been continuously off all growth factors for at least 1 week.
  • Unsupported counts must be:

    • platelets ≥ 50,000/ml
    • Hgb ≥ 9 gm/ul
    • Absolute neutrophil count ≥ 1000/µL
    • Absolute lymphocyte count ≥ 500/µL
  • Patients must have a current performance status of 0-1 (Eastern Cooperative Oncology Group) or 70-100% (Karnofsky.
  • Patients must be afebrile, off antibiotics therapeutic (not prophylactic), and free of evidence of active infection. Patients must be off intravenous (IV) hyperalimentation and IV fluids.
  • Minimum laboratory values within 2 weeks of entry: Creatinine ≤ 2.0 mg/dl or CrCl ≥ 50 ml/min, Bilirubin, ALT ≤ 2 x normal
  • Age >18 years
  • Patients receiving or scheduled to receive planned radiation therapy, growth factor therapy, or steroid therapy during the study period will be ineligible. Patients must have completed all planned post-transplant radiation therapy if applicable.
  • Patients must be able to give written informed consent and agree to comply with the study parameters
  • Patients must agree to use contraception during the study.

Exclusion Criteria:

Patients with one or more of the following:

  • Active infection, or fever >38.2˚C
  • Significant nonmalignant disease including documented HIV infection, uncontrolled hypertension (diastolic blood presses >115 mmHg), unstable angina, congestive heart failure (NY Class II), poorly controlled diabetes, coronary angioplasty within 6 months, myocardial infarction with the last 6 months, or uncontrolled atrial or ventricular cardiac arrhythmias.
  • Hematopoietic growth factors administered within 1 week of study entry.
  • Expected to require additional cytotoxic therapy within 30 days of study
  • Receiving other post-transplant investigational agents
  • Patients with a history of autoimmune diseases will be ineligible for this protocol
  • It is unknown whether CpG 7909 may exacerbate autoimmune disorders by its immunomodulatory effects. Therefore, subjects with a history of autoimmune disease should not receive CpG 7909. Controlled thyroid disease is permissible.
  • Systemic corticosteroids or other immunosuppressants
  • Pregnant or lactating (It is unlikely and probably unwise that a women of childbearing potential become pregnant this early after transplant, however; if any suspicion, a pregnancy test should be done)
  • Not meeting one or more of the eligibility criteria, as listed above

Information from the National Library of Medicine

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 identifier (NCT number): NCT00369291

Layout table for location information
United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Layout table for investigator information
Principal Investigator: Marcie Tomblyn, MD, MS Masonic Cancer Center, University of Minnesota
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota Identifier: NCT00369291    
Other Study ID Numbers: 2003LS014
UMN-0302M41542 ( Other Identifier: IRB, University of Minnesota )
UMN-MT2003-03 ( Other Identifier: Blood and Marrow Transplantation Program )
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Germ Cell and Embryonal
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Keyhole-limpet hemocyanin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs