Phase II Feasibility Study of Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: Autologous Dendritic Cell; Temozolomide; Radiotherapy; Dendritic Cell Vaccine
Intervention description: Vaccine given by cervical lymph node injection 3 times every other week; Radiotherapy (RT) with concurrent temozolomide (TMZ) for 6 weeks before vaccine is SOC; RT is standard of care (SOC) post surgery; Vaccine given cervical lymphnode injection 3 times every other week
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: immunotherapy; cancer vaccine; glioblastoma multiforme

Summary:

      Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme will be
      treated with radiotherapy/chemotherapy followed by dendritic cell vaccine. Chemotherapy will
      be administered after three vaccinations for one year or until progression of disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven GBM with central pathology review at Dartmouth-Hitchcock Medical
             Center (DHMC)

          -  Tumor specimen obtained at the time of surgery adequate for vaccination

          -  18 years of age or older

          -  Karnofsky Performance Status 60% or greater

          -  Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10 9th/L

          -  Platelets greater than or equal to 100 x 10 9th/L

          -  Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) less than or equal
             to 5 times the upper limits of normal (ULN)

          -  Total bilirubin less than or equal to 1.5 times ULN

          -  Serum creatinine less than or equal to 1.5 times ULN, OR estimated creatinine
             clearance greater than or equal to 60 mL/min

          -  No known immunosuppression other than chemo-related

          -  Negative HIV serologies

          -  No evidence of acute or chronic hepatitis on standard hepatitis C and B screening
             tests

          -  No chemotherapy within four weeks prior to leukapheresis

          -  Radiotherapy at outside institution is permitted if tissue was obtained at time of
             surgery at DHMC and patient is willing to follow-up per protocol

          -  Off steroids for at least two weeks before leukapheresis

          -  No second malignancies except non-melanoma skin cancer, and non-invasive cancer such
             at cervical CIS, superficial bladder cancer or breast CIS

          -  Negative serum or urine pregnancy test for women of childbearing potential

          -  No serious uncontrolled medical disorder or active infection

          -  All patients must give informed consent

          -  No history of clinical evidence of active autoimmune disease

        Exclusion Criteria:

          -  Invasive cancers in the past 5 years

          -  Rheumatologic/autoimmune disease

          -  Pregnancy or unwillingness to remain on acceptable form of birth control during study

          -  Major cardiac, pulmonary, or other systemic disease; viral hepatitis; HIV infection