Phase II Feasibility Study of Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Treatments: Temozolomide; Vaccines

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