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Surgical Resection With Gliadel Wafer Followed by Dendritic Cells Vaccination for Malignant Glioma Patients
This study is currently recruiting participants.
Verified by Cedars-Sinai Medical Center, December 2007
Sponsored by: Cedars-Sinai Medical Center
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00576446
  Purpose

Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis carries with it a median survival of approximately 12 months, with 90 - 95% of patients surviving less than 2 years. The current standard treatment of surgical resection followed by radiation therapy and chemotherapy has not substabntially prolonged survival and even the few treatment options shown to exhibit small increases in survival primarily benefit certain ( i.e., young ) patient subpopulations.

Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body to recognize the tumor cells as foreign and produce its own response to fight off recurring tumor cells. A promising means of causing an immune response so the body can create this immunity is through the use of dendritic cell ( DC ) vaccines.

Dendritic cells are a small group of cells contained in everyone's white blood cell population. These cells are responsible for letting the immune system know that something foreign, like bacteria, or a tumor, is in the body. Dendritic cells help the body ward off disease by alerting the immune system.

gliadel is an FDA - approved drug - a wafer containing a concentrated amount of a chemotherapy agent. These wafers are placed into the brain cavity after the tumor is resected ( removed ) and deliver a steady amount of immediate chemotherapy medicine to the surrounding brain tissue. Also, since Gliadel is a local chemotherapy, it will prevent the detrimental suppression ( weakening ) of the immune system shown with systemic ( throughout the body ) chemotherapy.

In prior Phase l and phase ll studies, patients who received chemotherapy following Dendritic cells demonstrated longer progression free and overall survival than the patients who received Dendritic cells or chemotherapy alone.

The purpose of this study is to determine whether after standard therapy of tumor resection surgery, along with placement of Gliadel wafers at time of surgery followed by dendritic cell vaccines will not only generate ( start ) an immune response, but will provide longer progression free survival.

Patients who were screened and not enrolled in this clinical trial due to screen failure will be notified of the reason for screen failure. Pre HIV counselling and appropriate referral resources will be provided. If the screen failure is due to the positive HIV test, appropriate post HIV counselling will be provided and appropriate referrals will be made. The charts of the patients with screen failures will be destroyed.The patients charts who will be enrolled in the study kept in the locked cabinet in the research office. patients will be assigned a unique identifying code known only to the research team. Data will be captured by various source documents, or, as necessary, abstracted from hospital medical records by an experienced registered nurse. The electronic data for viral etsting will be accessible to research personnel only.


Condition Intervention Phase
Malignant Glioma
Biological: Dendritic cell Vaccine
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Carmustine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase l Trial of Surgical Resection With Gliadel Wafer Placement Followed by Vaccination With Dendritic Cells Pulsed With Tumor Lysate for Patients With Malignant Glioma

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • To assess the survival of malignant glioma a, to assess the immunogenecity of patients who receive Dendritic cell vaccine , to assess progression free survival and to evaluate quality of life. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: April 2007
Estimated Study Completion Date: April 2009
Arms Assigned Interventions
1: Experimental Biological: Dendritic cell Vaccine
Patients will receive three vaccines every two weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a histopathological diagnosis of malignant gliomma
  • Patients must have undergone surgery and placement of Gliadel wafer.
  • Women of child bearing potentialmust use medically accepted form of birth control.
  • A Karnofsky performance status of at least 60%
  • Must be off of steroid at least two weeks prior to vaccination
  • Hematologic and metabolic panel results will be within the parameters of the protocol.
  • Must be capable of IRB approved Informed Consent.

Exclusion Criteria:

  • Patients with systemic disease
  • Presence of acute infection
  • Contraindication to MRI
  • Known history of autoimmune disorder
  • Pregnancy
  • Positive for hepatitis B, C, HIV, syphilis, HTLVa nd HCV
  • Allergic to Gentamicin.
  • Inability to participate as per Principal Investigator's discretion.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576446

Contacts
Contact: Marites O. Francisco, RN 310 423 0022 Marites.Francisco@cshs.org

Locations
United States, California
Cedars Sinai Medical center Recruiting
8700 Beverly Blvd., California, United States, 90048
Contact: Marites O. Francisco, RN     310-423-0022     Marites.Francisco@cshs.org    
Principal Investigator: John Yu, M.D.            
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: John Yu, M.D. Cedars-Sinai Medical Center
  More Information

Responsible Party: Cedars Sinai Medical Center ( John Yu, M.D. )
Study ID Numbers: 9789
Study First Received: December 18, 2007
Last Updated: December 18, 2007
ClinicalTrials.gov Identifier: NCT00576446  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Carmustine
Neuroepithelioma
Glioma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009