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

Dartmouth Health

Status and phase

Completed

Phase 2

Conditions

Glioblastoma Multiforme

Treatments

Drug: Temozolomide

Biological: Autologous Dendritic Cell

Procedure: Radiotherapy

Biological: Dendritic Cell Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT00323115

D0536

Details and patient eligibility

About

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.

Full 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 and seven weeks after completing radiotherapy/chemotherapy, patients will undergo leukapheresis to collect white blood cells. These cells will be grown into dendritic cells, and cultured with tumor cells from the individual patient. Vaccinations will be given every two weeks for a total of three vaccinations. Four weeks after the third vaccination patients will resume chemotherapy for one year or until disease progression.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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