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

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Brief Title

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

Official Title

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

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.
    

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Impact of dose escalation of CpG 7909 on primary immune readouts

Condition

Germ Cell Tumor

Intervention

keyhole limpet hemocyanin

Study Arms / Comparison Groups

 CpG 7909
Description:  Patients treated with CpG 7909 oligodeoxynucleotides (ODNs) after autologous transplantation to enhance immune reconstitution.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

19

Start Date

September 2003

Completion Date

May 2010

Primary Completion Date

May 2010

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Marcie Tomblyn, MD, MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00369291

Organization ID

2003LS014

Secondary IDs

UMN-0302M41542

Responsible Party

Sponsor

Study Sponsor

Masonic Cancer Center, University of Minnesota


Study Sponsor

Marcie Tomblyn, MD, MS, Principal Investigator, Masonic Cancer Center, University of Minnesota


Verification Date

November 2017