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

NCT ID: NCT00323115

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2013-07-31

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 administered after three vaccinations for one year or until progression of disease.

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 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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vaccine

Group Type: EXPERIMENTAL

Autologous Dendritic Cell

Intervention Type: BIOLOGICAL

Vaccine given by cervical lymph node injection 3 times every other week

Temozolomide

Intervention Type: DRUG

Radiotherapy (RT) with concurrent temozolomide (TMZ) for 6 weeks before vaccine is SOC

Radiotherapy

Intervention Type: PROCEDURE

RT is standard of care (SOC) post surgery

Dendritic Cell Vaccine

Intervention Type: BIOLOGICAL

Vaccine given cervical lymphnode injection 3 times every other week

Interventions

Autologous Dendritic Cell

Vaccine given by cervical lymph node injection 3 times every other week

Intervention Type: BIOLOGICAL

Temozolomide

Radiotherapy (RT) with concurrent temozolomide (TMZ) for 6 weeks before vaccine is SOC

Intervention Type: DRUG

Radiotherapy

RT is standard of care (SOC) post surgery

Intervention Type: PROCEDURE

Dendritic Cell Vaccine

Vaccine given cervical lymphnode injection 3 times every other week

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camilo E. Fadul, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

References

Fadul CE, Fisher JL, Hampton TH, Lallana EC, Li Z, Gui J, Szczepiorkowski ZM, Tosteson TD, Rhodes CH, Wishart HA, Lewis LD, Ernstoff MS. Immune response in patients with newly diagnosed glioblastoma multiforme treated with intranodal autologous tumor lysate-dendritic cell vaccination after radiation chemotherapy. J Immunother. 2011 May;34(4):382-9. doi: 10.1097/CJI.0b013e318215e300.

Reference Type: RESULT

PMID: 21499132 (View on PubMed)

Other Identifiers

D0536

Identifier Type: -

Identifier Source: org_study_id