ITI-OC CLINICAL TRIALS FOR OVARIAN CANCER
IITI-OC is seeking funding for a Phase I/II clinical trial using a personalized vaccine for recurrent ovarian cancer at The University of Pennsylvania Ovarian Cancer Research Center. The principal investigator for the trial is Dr. George Coukos and the Penn Investigational New Drug ("IND") sponsors are Drs. Carl June and Daniel Powell.
A Phase I clinical trial was launched in December, 2007 at the University of Pennsylvania using a dendritic cell vaccine. In February, 2008, a Phase I follow-on trial began at Penn using an adoptive T-cell transfer protocol developed by Dr. Coukos and others. The total number of subjects entered into the study included 3 (tumor/ascites collection and enrollment) and 37 subjects from which tumor has been collected (first step of the protocol). Dr. Coukos' team is planning on treating eligible candidates (4) from this study before moving on to test a new vaccine to be manufactured at the University of Pennsylvania's Clinical Cell and Vaccine Production Facility.
For current status of Dr. Coukos' clinical trials, please visit the Gynecology Oncology link at:
http://www.uphs.upenn.edu/obgyn/clinical-trials/#gynonc
The two original sequential studies comprise an innovative combination of multiple treatment modalities. The personalized vaccine forms the cornerstone of the treatment regimen, and is complemented by administration of low doses of certain existing approved drugs to help improve the immune system environment, as well as by adoptive transfer of patients' T cells primed with the vaccine itself.
The personalized vaccine’s platform uses a patient's own tumor. This is harvested through surgery which is part of the standard of care. The tumor is processed immediately in the laboratory to isolate cells. These are then processed and loaded onto autologous dendritic cells prepared from patient’s own blood cells. The dendritic cells loaded with autologus tumor are the Vaccine “drug”. The vaccine is thus entirely personalized, as all of its components are derived from the patient. This vaccine will be injected into the patient’s skin multiple times to induce or fortify an immune response of the body against the tumor. Such vaccine approach is called therapeutic because it intends to help a patient already diagnosed with cancer eliminate the cancer from her own body.
The second study will add the adoptive transfer of T cells harvested from the patients after she has been primed with the vaccine. T-cells will be expanded in the laboratory. After T-cell transfer, the patient will continue receiving vaccine boosts.
The Penn investigators are determined to improve upon the above study design, and parallel work will continue in the laboratory to advance our methods to prepare and deliver immunotherapy through incessant experimentation.
For additional information about the ITI-OC funded clinical trials, please visit:
http://www.uphs.upenn.edu/obgyn/clinical-trials/ /
INNOVATIVE CLINICAL TRIALS AT PENN OCRC:
CURRENT TRIALS: OVARIAN CANCER
UPCC-11807: A Phase I Clinical Trial Of Autologous Dendritic Cell Vaccine Loaded
With Autologous Tumor Cell Lysate Combined With Bevacizumab And Low Dose
Cyclophosphamide For Recurrent Ovarian And Primary Peritoneal Cancer,
George Coukos, PI *
UPCC-01808: A Phase I Trial Of Maintenance Vaccination Combined With Oral
Metronomic Cyclophosphamide With Adoptive Transfer Of Vaccine Primed
Cd3/Cd28- Costimulated Autologous T-Cells For Recurrent Ovarian Or Primary Peritoneal
Cancer Previously Vaccinated With Autologous Tumor Dendritic Cell Vaccine,
George Coukos, PI *
*These two trials are conducted in sequence.
UPCC-06807: A Phase I Open-Label, Dose Escalation Study Of The Safety And
Preliminary Efficacy Of Egen- 001 In Combination With Carboplatin And Docetaxel In Women
With Recurrent, Platinum-Senstive, Epithelial Ovarian Cancer, Christina Chu Pi.
UPCC-04808: A Phase I, Dose Escalation Clinical Trial Of Liposomal Pegylated Doxorubicin And Interleukin-18 Combination In Recurrent Advanced Stage Epithelial Ovarian Cancer, Christina Chu Pi
UPCC-809396____: Multicenter, Phase I, Dose Escalation, Multiple Dose Study Of The Safety And Preliminary Efficacy Of Dta-H19 Targeted Therapy In Patients With Recurrent, Platinum Resistant Ovarian Cancer With Ascites, George Coukos, Pi
CLINICAL TRIALS: IN PREPARATION
Phase I Clinical Trial Of Autologous Mesothelin Redirected T Cells Engineered For Enhanced Survival Administered By Intravenous Or Intratumoral Injection In Ovarian Cancer Patients, Christina Chu Pi
Phase I Clinical Trial Of Adoptive Transfer Of Ex Vivo Costimulated Autologous Tumor-Infiltrating T Cells In Ovarian Cancer Patients. George Coukos, Pi
ABOUT FDA CLINICAL TRIALS
For information about current recruiting for FDA-approved clinical trials, please visit:
http://www.clinicaltrials.gov.
Clinical trials can focus on new uses of existing treatments, or they may involve studies of new drugs that have not yet been approved by the US Food and Drug Administration (FDA). New treatments are studied in 3 phases to learn about side effects and how well they work.
PHASE I CLINICAL TRIALS:
The purpose of a phase I study is to find the best way to give a new treatment and how much of it can be given safely. The cancer team watches patients carefully for any harmful side effects. The treatment has been well tested in lab and animal studies, but the side effects in patients are not completely known. Doctors conducting the clinical trial start by giving very low doses of a drug to the first patients and increasing the dose for later groups of patients until side effects appear. Although doctors are hoping to help patients, the main purpose of a phase I study is to test the safety of the drug or treatment.
PHASE II CLINICAL TRIALS:
These studies are designed to see if the drug or treatment works. Patients are given the highest dose that doesn’t cause severe side effects (determined from the phase I study), and patients are closely observed to learn whether the drug affects the cancer or symptoms. The doctors also look for side effects.
PHASE III CLINICAL TRIALS:
Phase III studies involve large numbers of patients—often several hundred. One group (the control group) receives the standard (most accepted) treatment. The other group receives the new treatment. All patients in phase III studies are closely watched. The study will be stopped if the side effects of the new treatment are too severe or if one group has much better results than the others.