Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme

Criteria the registry did not label

• Abbreviated Inclusion Criteria:
• To be assessed at study enrollment prior to standard of care chemo-radiation therapy:
• Age ≥ 18 years.
• Histopathologically proven newly-diagnosed de novo GBM (WHO Grade IV glioma)
• The tumor must have a supratentorial component.
• Must have undergone definitive surgical resection of tumor with less than approximately 3cm x 3cm residual enhancing tumor as product of longest perpendicular planes by MRI.
• Recovery from the effects of surgery, postoperative infection, and other complications.
• Diagnostic contrast-enhanced MRI or CT scan of the brain preoperatively and postoperatively.
• Karnofsky Performance Status of ≥ 70.
• Signed informed consent.
• For females of childbearing potential, negative serum pregnancy test.
• Women of childbearing potential and male participants must be willing to practice adequate contraception throughout the study and for at least 24 weeks after the last dose of study drug.
  • To be assessed prior to initiation of adjuvant TMZ:
• Must have completed RT (targeted total dose of 59.4-60.0 Gy over ≤ 7 weeks) and concomitant TMZ (targeted dose of 75mg/m2/d for ≤ 49 days) therapy without significant toxicity that persisted over 4 weeks.
• History \& physical with neurologic examination prior to initiation of adjuvant TMZ.
• For patients receiving steroids, daily dose must be ≤ 4 mg.
• CBC with differential with adequate bone marrow function.
• Adequate renal function.
• Adequate hepatic function.
  • Abbreviated Exclusion Criteria:
  • To be verified in order to randomize subject:
• Prior invasive malignancy unless disease free for ≥ 3 years.
• Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.
• Recurrent or multifocal malignant gliomas.
• HIV, Hepatitis B, or Hepatitis C seropositive.
• Known active infection or immunosuppressive disease.
• Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region.
• Prior radiotherapy to the head or neck, resulting in overlap of radiation fields.
• Severe, active co-morbidity.
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period.
• Pregnant or lactating women.
• Prior allergic reaction to temozolomide, GM-CSF or Td.
• Prior history of brachial neuritis or Guillain-Barré syndrome.
• Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry.
  • To be assessed prior to initiation of adjuvant TMZ:
• Did not start radiation therapy and temozolomide within 7 weeks of surgery.
• Progression of disease as defined by modified RANO criteria.
• More than 45 days after completion of radiation therapy and temozolomide