Vaccine Therapy and Imiquimod in Treating Patients With High Risk or Recurrent Grade II Gliomas

Inclusion Criteria

• PATHOLOGICAL CRITERIA:
• For Cohort 1 and 2, participants must have documented pathological diagnosis of a WHO grade II astrocytoma or oligoastrocytoma
• For Cohort 3, participants must have WHO grade II astrocytoma, oligoastrocytoma or oligodendroglioma that is histologically confirmed either by the previous biopsy or resection, or at the time of re-operation (re-operation before entry to the current study is allowed; however participants must be off post-surgery dexamethasone for at least 4 weeks before administration of the first vaccine)
• DISEASE AND PRIOR STATUS CRITERIA:
• Cohort 1: Patients must have undergone surgery or biopsy alone (no postoperative radiation or chemotherapy) and have a baseline MRI scan (within 4 weeks of the first vaccine) that shows stable disease or regression (no progression from the initial surgery/biopsy based on Response Assessment in Neuro-Oncology [RANO] criteria)
• Cohort 2: Patients received surgery or biopsy and radiation therapy (RT) (including fractionated external beam radiation therapy and/or stereotactic radiosurgery, and/or chemotherapy), which was completed >= 3 months prior to enrollment, and have a baseline magnetic resonance imaging (MRI) scan within 4 weeks prior to the first vaccine that shows shows no progression after RT or after chemotherapy (based on RANO criteria). Patients may have received radiation therapy, chemotherapy or both in the past. For patients who received radiation and chemotherapy as part of combined sequential therapy, patients will be eligible if MRI demonstrates no progression 3 months from completion of whichever of the combination of radiation therapy and chemotherapy was completed last
• Cohorts 1 and 2: In addition, patients have to meet one of the following high risk conditions: * Age >= 40 with any extent resection * Age 16-39 with incomplete resection (post-op MRI showing > 1 cm residual disease, based on the maximum dimension of residual T2 or fluid-attenuated inversion recovery [FLAIR] abnormality from the edge of the surgical cavity either laterally, anteroposteriorly, or superoinferiorly) * Age 16-39 with neurosurgeon-defined gross total resection (GTR) but the tumor size is >= 4 cm (the maximum preoperative tumor diameter, based on the axial and/or coronal T2 or FLAIR magnetic resonance [MR] images)
• Cohort 3: Patients with recurrent WHO grade 2 glioma may have received prior external beam radiotherapy and/or chemotherapy; patients with stable WHO grade 2 glioma must have had prior chemotherapy (at least one cycle of temozolomide or procarbazine, lomustine, and vincristine [PCV]-based chemotherapy); with regard to the prior therapy in Cohort 3, patients may have had treatment for no more than 2 prior relapses; relapse is defined as progression following initial therapy (i.e. radiation +/- chemo if that was used as initial therapy) or observation of stable disease; the intent therefore is that patients may have had 3 prior therapies (initial therapy and treatment for 2 relapses); if the patient had a surgical resection for relapsed disease, and no anti-cancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered as 1 relapse * In Cohort 3 with recurrence, tumor recurrence is defined by the increase of maximum tumor diameter, based on the axial and/or coronal T2 or FLAIR MR images; increase of tumor size can be based on comparison with previous scans performed up to prior 3 years to allow assessment of slow-growth of the tumor * In Cohort 3, patients must have recovered from the toxic effects of prior therapy: 4 weeks from any investigational agent, 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 4 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count); any questions related to the definition of non-cytotoxic agents should be directed to the Principal Investigator; with regard to previous RT, there must be at least 6 months from the completion of RT (or radiosurgery)
• Karnofsky performance status >= 60%
• Clinically stable and off corticosteroids for at least 4 weeks prior to study enrollment
• Absolute neutrophil (segmented and bands) count (ANC) >= 1.0 x 10^9/L
• Platelets >= 100 x 10^9/L
• Hemoglobin >= 8 g/dL
• Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x upper limit of normal (ULN) for age
• Normal serum creatinine or creatinine clearance >= 60 ml/min/1.73 m^2
• Must be free of systemic infection; subjects with active infections (whether or not they require antibiotic therapy) may be eligible after complete resolution of the infection; subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatment
• Sexually active females of child bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of the vaccination period; sexually active males must agree to use barrier contraceptive for the duration of the vaccination period
• Patient (or parents/guardians, in the case of minors) must sign an informed consent document indicating that they are aware of the investigational nature of this study, which includes an authorization for the release of their protected health information

Exclusion Criteria

• Presence of gliomatosis cerebri, cranial or spinal leptomeningeal metastatic disease
• Pathological diagnosis for the recurrent disease demonstrate transformation to higher grade (i.e. WHO grade III or IV) gliomas, even if the initial diagnosis was WHO grade II glioma
• Pregnant or breast-feeding; pregnancy testing will be performed on all menstruating females within 14 days prior to study enrollment
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
• Currently receiving any investigational agents or registration on another therapy based trial
• History of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) that required systemic immunosuppression therapy and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, acquired immunodeficiency syndrome (AIDS), ongoing pregnancy, transplant immunosuppression)
• Any isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism)
• Any conditions that could potentially alter immune function (AIDS, multiple sclerosis, diabetes, renal failure)
• Receiving ongoing treatment with immunosuppressive drugs, excluding those patients requiring steroids for treatment of tumor-related edema or as part of perioperative treatment
• Requiring any of the following concurrent treatment or medications: * Radiation therapy * Chemotherapy * Interferon (e.g. Intron-A®) * Allergy desensitization injections * Growth factors (e.g. Procrit®, Aranesp®, Neulasta®) * Interleukins (e.g. Proleukin®) * Any investigational therapeutic medication
• Prior cancer diagnosis except that the following: * Squamous cell cancer of the skin without known metastasis * Basal cell cancer of the skin without known metastasis * Carcinoma in situ of the breast (ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS]) * Carcinoma in situ of the cervix * Any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 5 years
• Participants with known addiction to any drugs