Vaccination-Dendritic Cells With Peptides for Recurrent Malignant Gliomas
|ClinicalTrials.gov Identifier: NCT00766753|
Recruitment Status : Completed
First Posted : October 6, 2008
Results First Posted : May 11, 2017
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Biological: Dendritic vaccine pulsed with multiple peptides Biological: The first booster vaccine phase: Biological: The second booster vaccine phase:||Phase 1 Phase 2|
This is a single-institution Phase I/II study designed to evaluate the safety, the induction of an immune response, and the preliminary clinical response of vaccinations with Type-1 αDCs (αDC1) loaded with glioma-associated antigen (GAA) epitopes and administration of poly-ICLC in patients with recurrent malignant gliomas. The hypothesis is that this form of vaccines in combination with poly-ICLC treatment will prove to be safe, and will induce potent anti-glioma immune responses.
The primary objective is to establish the safety of the approach.
The secondary objectives are to 1) assess the immunological response against GAAs in patients with recurrent malignant gliomas immunized with DCs loaded with GAA-derived peptides using enzyme-linked immuno-spot (ELISPOT), delayed-type hypersensitivity (DTH) and tetramer assays and 2) assess the preliminary anti-tumor clinical activity of the vaccines as measured by radiological response (MRI), overall survival, and four- and six-month progression-free survival (PFS).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Evaluation of Vaccination With Type 1 Dendritic Cells Pulsed With Multiple Peptides in the Treatment of HLA-A2 Positive Patients With Recurrent Malignant Gliomas|
|Actual Study Start Date :||December 2006|
|Primary Completion Date :||September 2009|
|Study Completion Date :||June 2016|
All consenting, eligible subjects receive the intervention
Biological: Dendritic vaccine pulsed with multiple peptides
Subjects will receive four (4) injections of the vaccine into the lymph nodes. Injection is guided by ultrasonography. Subjects will receive the first cycle of vaccine in the right groin. Two weeks after the first vaccine, subjects receive the same vaccine at the left groin, followed by the 3rd and the 4th vaccines in the left and right armpits, respectively, with two-week intervals. Each injection contains 0.2cc (less than 1/20th of a teaspoon) of a saline solution containing the vaccine cell mixture.Biological: The first booster vaccine phase:
This phase will begin at week 13. These subjects will be treated with additional vaccinations every 4 weeks to a maximum of 5 vaccine injections and, if poly-ICLC is available from the supplier starting on the day of the first additional vaccine and twice/week for 8 injections following each additional vaccine. If poly-ICLC supply is not available from the supplier, DC vaccines only will be given in the booster phases.Biological: The second booster vaccine phase:
At week 33, following the completion of 5 additional vaccines, if participants demonstrate stable disease or positive clinical response, if poly-ICLC supply is still available, participants will be offered additional DC-vaccines and poly-ICLC treatment. The second phase booster vaccines can be continued as long as the patient shows continued positive response or stable disease (both radiological and clinically) with no major adverse events, and as long as funding is available for the study. DC vaccines in this phase will be administered every 6 months+/- 2 weeks.
2). Poly-ICLC at 10µg/kg and up to 1640 µg/injection will be administered intramuscularly (i.m.) on the day of each booster DC vaccine. Poly-ICLC will be administered weekly thereafter for twice (at one week and two weeks after each vaccine) (e.g. if the previous DC vaccine was administered on a Thursday, subsequent poly-ICLC will be administered on the next two Thursdays
- Number of Participants Who Experienced Treatment-related Dose Limiting Toxicities (DLT) [ Time Frame: up to 8 weeks ]Number of participants who experienced treatment-related Dose Limiting Toxicities (DLT) at any dose level.
- Median Time To Progression [ Time Frame: At baseline, 9, 17, 25, and 33 weeks, and every 3 months; up to 23 months ]Median number of months until disease progression. Tumor size was assessed using magnetic resonance imaging (MRI) scans with contrast enhancement to detect change from baseline.
- 12-month- Progression Free Survival (PFS) [ Time Frame: Up to 12 months ]Number of patients with progression-free status lasting at least 12 months
- Overall Survival (OS) [ Time Frame: Up to 102 months ]Time interval from start of treatment until date of death.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766753
|United States, Pennsylvania|
|Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Frank Lieberman, MD||University of Pittsburgh|