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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00323115
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Dartmouth-Hitchcock Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Camilo E. Fadul, MD
Principal Investigator Affiliation Dartmouth-Hitchcock Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Additional Details

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.

Arms & Interventions

Arms

Experimental: Vaccine

Interventions

Biological: - Autologous Dendritic Cell

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

Drug: - Temozolomide

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

Procedure: - Radiotherapy

RT is standard of care (SOC) post surgery

Biological: - Dendritic Cell Vaccine

Vaccine given cervical lymphnode injection 3 times every other week

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

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