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

Primary Purpose

Germ Cell Tumor, Leukemia, Lymphoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
keyhole limpet hemocyanin
tetanus toxoid
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Germ Cell Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Masonic Cancer Center at University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CpG 7909

Arm Description

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

Outcomes

Primary Outcome Measures

Enhanced immune function as measured by response to keyhole limpet hemocyanin and tetanus toxoid
anti-KLH IgG

Secondary Outcome Measures

Impact of dose escalation of CpG 7909 on primary immune readouts
Compare primary outcome between cohorts

Full Information

First Posted
August 24, 2006
Last Updated
November 27, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00369291
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
September 2003 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Germ Cell Tumor, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CpG 7909
Arm Type
Experimental
Arm Description
Patients treated with CpG 7909 oligodeoxynucleotides (ODNs) after autologous transplantation to enhance immune reconstitution.
Intervention Type
Biological
Intervention Name(s)
keyhole limpet hemocyanin
Other Intervention Name(s)
KLH
Intervention Description
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).
Intervention Type
Biological
Intervention Name(s)
tetanus toxoid
Intervention Description
Tetanus toxoid booster 0.5 ml intramuscularly (IM) in the opposite arm (per MT1999-06)
Primary Outcome Measure Information:
Title
Enhanced immune function as measured by response to keyhole limpet hemocyanin and tetanus toxoid
Description
anti-KLH IgG
Time Frame
1 Month after vaccine
Secondary Outcome Measure Information:
Title
Impact of dose escalation of CpG 7909 on primary immune readouts
Description
Compare primary outcome between cohorts
Time Frame
At study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcie Tomblyn, MD, MS
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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

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