Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma

Completed · Phase 1

Conditions studied: Malignant Glioma

In brief

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.

Key facts

Study ID

NCT01792505

Run by

Cedars-Sinai Medical Center

People needed

71

Starts

2009-10-01

Expected to finish

2016-10-01

Last updated by the study team

2017-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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