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

NCT00369291 | Terminated Phase 1 DMC

• 3 other identifiers: 2003LS014UMN-0302M41542UMN-MT2003-03
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Germ Cell Tumor; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm

Outcome Measures

Primary Outcomes (1)

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

  anti-KLH IgG

  1 Month after vaccine

Secondary Outcomes (1)

• Impact of dose escalation of CpG 7909 on primary immune readouts

  At study completion

Study Arms (1)

CpG 7909

EXPERIMENTAL

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

Biological: keyhole limpet hemocyanin; Biological: tetanus toxoid

Interventions

keyhole limpet hemocyanin BIOLOGICAL

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).

Also known as: KLH

CpG 7909

tetanus toxoid BIOLOGICAL

Tetanus toxoid booster 0.5 ml intramuscularly (IM) in the opposite arm (per MT1999-06)

CpG 7909

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal; Leukemia; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

keyhole-limpet hemocyanin; Tetanus Toxoid

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Marcie Tomblyn, MD, MS

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 29, 2006
• Study Start: September 1, 2003
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)