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Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01792505
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis carries with it a median survival of approximately 24 months. The current standard treatment of surgical resection followed by radiation therapy and chemotherapy has not substantially 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 are 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.


Condition or disease Intervention/treatment Phase
Malignant Glioma Biological: Dendritic Cell Vaccine in combination with Imiquimod cream Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Surgical Resection Followed by Vaccination With Dendritic Cells Pulsed With Tumor Lysate With Imiquimod for Patients With Malignant Glioma
Study Start Date : October 2009
Primary Completion Date : November 14, 2014
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Biological/Vaccine Biological: Dendritic Cell Vaccine in combination with Imiquimod cream
After a successful complete resection of malignant glioma, patients will receive a total of 3 vaccines, each are 2 weeks apart. Imiquimod cream will be applied prior to and after each vaccination.


Outcome Measures

Primary Outcome Measures :
  1. safety of an autologous tumor lysate- loaded dendritic cell (DC) vaccine with Imiquimod cream application [ Time Frame: 1 year ]
    Safety relative to vaccine will be monitored in terms of Serious Adverse Events according to FDA regulations and recorded on a MedWatch 3500a form. A Data Safety Monitoring Committee will meet every 6 months to review AEs/SAE's. In the event of any subject death within a 30 day period following study agent administration, the DSMC will review the death within that time frame. If two deaths are deemed to be "probably" or "definitely' related to study agent administration, all study agent administrations will be stopped and the FDA and IRB will be notified of study cessation.


Secondary Outcome Measures :
  1. progression free survival of patients after they receive tumor lysate-loaded DC vaccine with Imiquimod cream application. [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a histopathological diagnosis of malignant glioma.
  • Patients 18 years of age or older.
  • Patients must have undergone maximal surgical resection of malignant glioma
  • Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female.
  • Patients must have a Karnofsky performance score of at least 60%.
  • Patients must be off steroids for at least two weeks prior to vaccination.
  • Baseline hematologic and complete metabolic panel within one week of initiating therapy must fall within normal ranges
  • Patient must be capable of signing IRB approved Research Consent and Release of Medical Records form.

Exclusion Criteria:

  • Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.
  • The presence of an acute infection requiring active treatment will be criteria for delay or exclusion.
  • Contraindication to MRI procedure unless otherwise determined by PI.
  • Patients with a known history of an autoimmune disorder.
  • Pregnancy.
  • Patients positive for hepatitis B, hepatitis C, HIV I/II, syphilis, HTLV I/II, HCV.
  • Patients with allergy to Gentamicin.
  • Patient inability to participate as determined by PI discretion.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792505


Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: John Yu, MD Cedars-Sinai Medical Center
More Information

Responsible Party: John Yu, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01792505     History of Changes
Other Study ID Numbers: 19814
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vaccines
Imiquimod
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antineoplastic Agents
Interferon Inducers