A Phase I/II Randomized Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
This is a Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or
primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity
of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L)
administered by intradermal/subcutaneous injection in combination with Ampligen
(poly-l:poly-C12U), a Toll-like receptor 3 agonist. Study duration is 24 months. This study
has two Phases eligible subjects enrolled in Phase 1 will receive the OC-L admixed with
Montanide ISA 51 with intravenous Ampligen. Subjects enrolled in Phase II will be
randomized to two ARMS. This randomized design will allow for the unbiased evaluation and
comparison of immune response among the 2 treatment arms. patients will be randomized (10
per treatment arm) in blocks of size 4 or 6, such that treatment assignment will be balanced
after each group of 4 or 6 patients has been randomized. ARM A 10 patients will receive
OC-L. Arm b 10 patients will receive OC-L with Ampligen. Following each vaccination,
subjects in Phase I and Arm B will be given intravenous Ampligen 3 times starting 2-3 days
after each vaccine administration. All subjects will receive vaccine on Day 0, 14, 28, 42
and 56. Subjects will receive Prevnar on day 0 and day 14. Subjects will be treated till
exhaustion of OC-L or disease progression whichever occurs first subjects will be contacted
every 6 months for up to 5 years and then annually for survival. The OC-L study product is
manufactured and quality tested at Cell and Vaccine Production Facility and then released to
IDS, where it will be admixed with Montanide ISA 51 VG on day of vaccination.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Number of Participants with Adverse Events
Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version 4.0). All toxicities observed within 30 days of last vaccination will be included. All patients that receive at least one vaccination will be included in the toxicity analysis.
within 30 days of last vaccination
Yes
George Coukos, MD, Ph.D
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
UPCC 29810
NCT01312389
March 2011
March 2013
Name | Location |
---|---|
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |