My Clinical Trial(s) in Immunotherapy

First, before moving into the details of these trials, let me orient you to this page. You are on the website called LivinglyDying. This page is for a particular type of clinical trial, immunotherapies.  It also features more information on the particular trial that I am on. If you return to the home page you will find  stories about navigating getting into any clinical trail and my experiences with these trials in particular. It can be a complicated process but I encourage tenacity and shared support – thus, this website. Please click the follow button so you will get updates as well as have reminders to return here to dig for details as new challenges may (or may not) emerge. And if I can offer direct support, I will. It is a complicated field with many current advances so stay active in finding the best match for your needs. Now back to immunotherapy!

Here is an overview from the American Cancer Society on the topic.

What is immunotherapy?

Immunotherapy is also sometimes called biologic therapy or biotherapy. It is treatment that uses certain parts of the immune system to fight diseases such as cancer. This can be done in a couple of ways.

• Stimulating your own immune system to work harder or smarter to attack cancer cells
• Giving you immune system components, such as man-made immune system proteins

For a long time doctors suspected that the immune system had an effect on certain cancers. Even before the immune system was well understood, William Coley, MD, a New York surgeon, first noted that getting an infection after surgery seemed to help some cancer patients. In the late 1800s, he began treating cancer patients by infecting them with certain kinds of bacteria, which came to be known as Coley toxins. Although he had some success, his technique was overshadowed when other forms of cancer treatment, such as radiation therapy, came into use.

Since then, doctors have learned a great deal about the immune system. This has led to research into how it can be used to treat cancer, using many different approaches. In the last few decades immunotherapy has become an important part of treating several types of cancer.

Immunotherapy includes a wide variety of treatments that work in different ways. Some seem to work by boosting the body’s immune system in a very general way. Others help train the immune system to attack cancer cells specifically.

Immunotherapy seems to work better for some types of cancer than for others. It is used by itself to treat some cancers, but for many cancers it seems to work best when used along with other types of treatment.

As researchers have learned more about the body’s immune system in recent years, they have begun to figure out how it might be used to treat cancer more effectively. Newer treatments now being tested seem to work better and will have a greater impact on the outlook for people with cancer in the future.

http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/immunotherapy/immunotherapy-what-is-immunotherapy

TRIAL ONE: The Autologous OC-DC Vaccine Trial was the original trial I started at UPenn with my first treatment in June of 2013.

Protocol Title: A pilot clinical trial of dendritic cell vaccine loaded with autologous tumor for recurrent ovarian, primary peritoneal or fallopian tube cancer.

Principal Investigator: Dr Janos Tanyi – Jordan Center for Gynecological Cancers at Penn, Perelman Center for Advanced Medicine, 3rd Floor West Pavilion – Philadelphia, PA 19104

To follow my personal experiences as a patient in Cohort Four of Phase One of this trial, please go to column on right, scroll down to categories and click on postings specific to clinical trial.

Contact: Clinical Team

215-615-7447

OCRC.Trials@uphs.upenn.edu

A detailed description:

Researchers at the Penn Ovarian Cancer Research Center (OCRC) are conducting clinical trials to examine the efficacy and safety of personalized tumor vaccines for the treatment of recurrent ovarian, fallopian tube, primary peritoneal and papillary serous endometrial cancers.

Cancer vaccines are designed to teach the immune system to attack and destroy cancer cells. Tumor cells often express distinct antigens known as tumor-associated antigens (TAAs). When the immune system is taught to recognize these antigens as foreign, an immune response is mounted against the tumor.

Vaccinating patients with personalized tumor vaccines, which are derived from the patient’s tumor tissue, has the benefit of conditioning the immune system to mount an immune response against the patients’ unique tumor antigens, as well as target multiple unknown antigens simultaneously. This approach also ensures that every patient has an opportunity to be vaccinated, as the number of molecularly defined TAAs in ovarian cancer is limited.

Penn researchers at the Ovarian Cancer Research Center have created vaccines from dendritic cells (DC), a subset of bone marrow-derived leukocytes, which can be isolated from tumor tissue collected at the time of surgery. These vaccines boost a patient’s pre-existing anti-tumor immune response and are capable of inducing an immune response against new tumor antigens in patients lacking spontaneous immunity.

Recently, Penn investigators have improved the vaccine platform and created a more immunogenic vaccine by treating patients’ tumor cells with an oxidizing agent that enhances the ability of dendritic cells to recognize and engulf tumor cells (Figure 1). To date, this new and improved therapeutic vaccine, called oxidized tumor cell-dendritic cell (OC-DC) vaccine, has been administered to 25 patients with recurrent ovarian cancer at Penn Medicine.

Preliminary results demonstrate that the vaccine is safe and immunogenic with immune response correlating with clinical benefit in most patients. Patients with clinical benefit have favorable immune parameters and some patients have achieved prolonged progression-free survival and remission.

Following vaccination, patients have the option to enroll in a second study where they receive their own vaccine-primed T cells. Using a technique developed at Penn, patient’s T cells are grown in the laboratory to expand the number of cells and then reintroduced into the patient after a lymphodepleting chemotherapy regimen (Figure 2). Because the T cells have already been primed via the personalized dendritic cell vaccine to attack the tumor cells, the adoptive T cell transfer amplifies the anti-tumor immune response. http://penn-medicine-clinical-reports.blogspot.com/2013/05/enrolling-clinical-trials-autologous.html

Future cohorts will include more combinatorial strategies.

Principal Investigator: Janos Tanyi, MD, PhD
Sponsor: George Coukos, MD, PhD
Contact: Melissa Moore 215-615-7447; or OCRC.Trials@uphs.upenn.edu
Study ID Number: UPCC 19809
ClinicalTrials.gov Identifier: NCT01132014

Autologous T-Cells Combined With Autologous OC-DC Vaccine in Ovarian Cancer

This is a phase-I clinical trial in patients with recurrent ovarian cancer, fallopian tube or primary peritoneal cancer who previously underwent induction vaccination with dendritic cell vaccine. The objective of the trial is to determine, in patients who have had cyclophosphamide/fludarabine lymphodepletion, the feasibility and safety of adoptive transfer of vaccine-primed, ex vivo CD3/CD28-costimulated peripheral blood autologous T cells, followed by intradermal vaccination with OC-DC in combination with bevacizumab.

Principal Investigator: Janos Tanyi, MD, PhD
Sponsor: George Coukos, MD, PhD
Contact: Melissa Moore 215-615-7447; or OCRC.Trials@uphs.upenn.edu
Study ID Number: UPCC 26810
ClinicalTrials.gov Identifier: NCT01312376

To stay current: http://www.uphs.upenn.edu/obgyn/clinical-trials/#gynonc

TRIAL TWO: AUTOLOGOUS T-­‐CELLS and IL-­‐18 

More details soon…..

Finding a clinical trial for YOU! Try – http://cancerresearch.org/cancer-immunotherapy/clinical-trial-finder

 

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