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

Completed · Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT00323115

Run by

Dartmouth-Hitchcock Medical Center

People needed

11

Starts

2006-05-01

Expected to finish

2013-07-01

Last updated by the study team

2018-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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