A Pilot Study to Evaluate the Effects of Imiquimod and Tumor Lysate Vaccine Immunotherapy for Adults With High Risk or Recurrent/Post-Chemotherapy WHO Grade II Gliomas
This is a pilot study of a vaccination regime that is designed to efficiently induce anti-tumor T-cell responses in patients with WHO grade II glioma. The proposed regime with BTIC Lysate in combination with imiquimod, an FDA-approved immune response modifier will induce potent anti-glioma immune response with minimal or no toxicity.
• Cohort 1 and 2: Age ≥18 year old with histologically diagnosed World Health Organization (WHO) grade II astrocytoma or oligoastrocytoma with high-risk factors - defined as:
‣ age ≥ 40 with any extent resection;
⁃ age 18-39 with incomplete resection (post-op MRI showing \>1cm 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) or
⁃ age 18-39 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 MR images) Cohort 3: Age ≥18 year old with histologically diagnosed WHO grade II glioma with recurrence
⁃ Karnofsky performance status ≥ 60%
⁃ Clinically stable and off corticosteroids for at least 4 weeks prior to study enrollment
⁃ Adequate organ function within 14 days of study registration including:
⁃ Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥1.0 x 109/L, platelets ≥100 x 109/L; hemoglobin ≥ 8 g/dL
⁃ Hepatic: - Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age and SGPT (ALT) ≤ 2.5 x upper limit of normal (ULN) for age
⁃ Renal: Normal serum creatinine or creatinine clearance ≥60 ml/min/1.73 m2