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

Stopped early · Phase 1

Conditions studied: Germ Cell Tumor, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

In brief

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.

Key facts

Study ID

NCT00369291

Run by

Masonic Cancer Center, University of Minnesota

People needed

19

Starts

2003-09-01

Expected to finish

2010-05-01

Last updated by the study team

2017-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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.

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

Where it is running

• Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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