Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
|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: NCT01902771|
Recruitment Status : Terminated (Lack of Accrual)
First Posted : July 18, 2013
Last Update Posted : March 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioma Brain Cancer Brain Tumor Glioblastoma Multiforme High Grade Glioma||Biological: Dendritic Cell Vaccine Biological: Tumor Lysate Other: Imiquimod Procedure: Leukapheresis||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Dendritic Cell Vaccine Therapy With In Situ Maturation for Pediatric Brain Tumors|
|Actual Study Start Date :||September 3, 2013|
|Actual Primary Completion Date :||October 24, 2016|
|Actual Study Completion Date :||January 26, 2017|
Experimental: DC Vaccine + Lysate
Biological: Dendritic Cell Vaccine
Post-Leukapheresis. Subjects will receive DC Vaccine administered once weekly, via intradermal injection, for 4 weeks for a total of four vaccinations, per study protocol.
Other Name: DC Vaccine
Biological: Tumor Lysate
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.
Subjects will self-apply Imiquimod topically to each designated vaccine site before and after scheduled administrations of DC Vaccine or Lysate, per study protocol.
Other Name: Aldara
Baseline, post-surgery. Subjects will undergo leukapheresis procedure during baseline, after recovery from surgery to collect peripheral blood mononuclear cells (PBMCs) from which dendritic cells will be obtained, per study protocol.
Other Name: Pheresis
- Rate of Toxicity in Study Participants Receiving Protocol Therapy [ Time Frame: Up to 28 Weeks ]Rate of treatment-limiting toxicities (TLT) and/or adverse events in study participants receiving protocol therapy.
- Rate of Feasibility of Protocol Therapy in Study Participants [ Time Frame: Up to 4 Weeks ]Rate of feasibility of protocol therapy in study participants. Feasibility refers to clinical feasibility - whether or not the patient can have enough monocytes removed to manufacture Dendritic Cells.
- Rate of Prolonged Survival or Prolonged Progression-Free Survival in Study Participants [ Time Frame: Up to 24 Months ]Rate of prolonged survival or prolonged progression-free survival in study participants. 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. 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.
- Rate of Measurable Immune Response in Subjects Receiving Protocol Therapy. [ Time Frame: Up to 24 months ]Rate of measurable immune response in subjects receiving protocol therapy demonstrated by measurement levels of Myeloid Derived Suppressor Cells before and after treatment.
- Comparison of clinical parameters of study participants versus associated outcomes for patients on other DC/Imiquimod studies. [ Time Frame: Up to 24 Months ]A comparison of whether the clinical parameters associated with outcomes described for patients on other DC/Imiquimod protocols hold for subjects treated on this study.
- Estimation of the Proportion of Subjects with Recurrent Pediatric Brian Tumors who are able to complete DC Vaccine therapy and DC Vaccine + Lysate Therapy. [ Time Frame: Up to 24 months ]Estimation of the proportion of subjects with recurrent pediatric brain tumors who are able to receive all administrations of DC, and the proportion who are able to receive all administrations of DC and Lysate.
- Identification of Parameters Associated with Poorer Activity of the Vaccine in Study Participants [ Time Frame: Up to 24 Months ]Identification of parameters associated with poorer activity of the DC Vaccine in Study Participants in order to develop therapies to augment vaccine therapy.
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): NCT01902771
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Edward Ziga, MD||University of Miami|