Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma

NCT01792505 | Completed Phase 1 DMC

• 1 other identifier: 19814
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Glioma

Outcome Measures

Primary Outcomes (1)

• safety of an autologous tumor lysate- loaded dendritic cell (DC) vaccine with Imiquimod cream application

  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.

  1 year

Secondary Outcomes (1)

• progression free survival of patients after they receive tumor lysate-loaded DC vaccine with Imiquimod cream application.

  1 year

Study Arms (1)

Biological/Vaccine

EXPERIMENTAL

Biological: Dendritic Cell Vaccine in combination with Imiquimod cream

Interventions

Dendritic Cell Vaccine in combination with Imiquimod cream BIOLOGICAL

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.

Biological/Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.
• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• John Yu, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: February 15, 2013
• Study Start: October 1, 2009
• Primary Completion: November 14, 2014
• Study Completion: October 1, 2016
• Last Updated: April 21, 2017

Record last verified: 2017-04

Locations

US (1)