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Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Yu, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01792505
First received: July 1, 2011
Last updated: April 19, 2017
Last verified: April 2017
  Purpose

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 Intervention Phase
Malignant Glioma Biological: Dendritic Cell Vaccine in combination with Imiquimod cream Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


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

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

Enrollment: 71
Study Start Date: October 2009
Study Completion Date: October 2016
Primary Completion Date: November 14, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 1, 2011
Last Updated: April 19, 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

ClinicalTrials.gov processed this record on July 24, 2017