CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant
Germ Cell Tumor, Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Germ Cell Tumor
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
Sites / Locations
- Masonic Cancer Center at University of Minnesota
Arms of the Study
Arm 1
Experimental
CpG 7909
Patients treated with CpG 7909 oligodeoxynucleotides (ODNs) after autologous transplantation to enhance immune reconstitution.