The purpose of this research study is to evaluate an investigational vaccine using patent-derived dendritic cells (DC) to treat malignant glioma or glioblastoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Between 1.2 to 12 million DC per dose administered once a week via intradermal injection for 4 weeks.
Post-DC Vaccine therapy. Up to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol.
5% topical cream applied to vaccine site before and after administrations of DC vaccine or lysate
University of Miami
Miami, Florida, United States
Number of Participants with Treatment-Related Adverse Events
Adverse Events will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0 by treating physician
Time frame: Up to Week 32 (30 days after last dose of protocol therapy)
Rate of Overall Survival (OS) in Study Participants
Rate of overall survival in study participants receiving protocol therapy. Overall survival is defined as the time elapsed from the start of treatment until death. For surviving patients, follow-up will be censored at the date of last contact.
Time frame: Up to Week 80 (5 years post therapy)
Rate of Progression-Free Survival (PFS) in Study Participants
Rate of prolonged progression-free survival in study participants receiving protocol therapy. Progression-Free Survival (PFS) is defined as the time elapsed from the start of treatment to the date of documented progression or death, whichever comes first. For surviving patients without progression who begin alternative treatment, PFS will be censored at the last date of documented progression-free status prior to starting alternative treatment. Similarly, losses to follow up will be censored at the last date of documented progression-free status.
Time frame: Up to Week 80 (5 years post therapy)
Change in MDSC Levels
Immune response will be reported as the change in Myeloid Derived Suppressor Cell (MDSC) levels from blood samples
Time frame: Baseline, Up to Week 28
Change in blood counts
Measurement of immune response will be reported as the change in red and white blood counts from blood samples evaluated in million cells/microliter
Time frame: Baseline, Up to Week 28
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Baseline, post-surgery blood draw via catheter to obtain peripheral blood mononuclear cells (PBMCs) from which Dendritic cells will be obtained.
Comparison of clinical parameters associated with outcomes in study participants to patients on other DC/Imiquimod studies.
To demonstrate if the clinical parameters associated with outcomes described for patients on other DC / imiquimod protocols hold for subjects treated on this study.
Time frame: Up to 5 years Post-Therapy
Proportion of participants completing intervention.
Proportion of participants able to receive all administrations of DC vaccine and those who are able to receive all administration of DC vaccine and lysate will be reported.
Time frame: Up to Week 28