Status:
COMPLETED
Phase II Feasibility Study of Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 administer...
Detailed Description
Two to six weeks after surgery, patients with newly diagnosed glioblastoma multiforme (GBM) will undergo a six-week course of radiotherapy with concurrent chemotherapy (temozolomide). Between three an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00323115
Start Date
May 1 2006
End Date
July 1 2013
Last Update
October 10 2018
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756