INDIANAPOLIS (WISH) – A new clinical trial at Franciscan Health Cancer Center is testing if a genetically altered bacteria strain connected with food poisoning, can be a treatment for those at a high risk of cervical cancer.
According to a release, the study is called The Phase 3. It’s testing the safety and efficacy of ADXS11-001, which is the study agent.
“This form of immunotherapy uses a modified but safe bacterium (Listeria monocytogenes) targeting human papillomavirus 16 (HPV16), which is said to be the source of 70 percent of all cervical cancer cases,” the release stated.
The trial is being executed in 20 countries at 150 sites.
“We are enrolling patients with advanced carcinoma of the cervix who are at high risk of recurrence after completing concurrent chemotherapy and radiation therapy and appear clinically free of disease.” said David H. Moore, MD, of Franciscan Physician Network Gynecologic Oncology Specialists, who is leading the study at the Indianapolis hospital. “Currently, these patients virtually have no treatment options if the cancer returns.”
Dr. Moore and his team, as well as Franciscan Health are seeking participants for the study. To be eligible for the study you must qualify for the following:
- Be 18 years or older
- Confirmed biopsy diagnosis of squamous cell, adenocarcinoma or adenosquamous carcinoma of the cervix and confirmation of the original primary tumor
- Completed a definitive therapy with curative intent to include chemotherapy and radiation therapy
- Demonstrate adequate organ function
- Receive a thorough health screening before accepted into the study
“Patients then receive a thorough health screening before they are accepted into the study,” Dr. Moore said. “Two-thirds of enrolled patients receive ADXS11-001 and the remainder is administered placebo.”
The patients and researchers will not know who is receiving the actual drug and who is not, in order to ensure accurate findings.
Participants will receive the drug every 21 days in three doses, followed by a dose every eight weeks for a total of five doses, or until the cancer returns.
The drug works as a “booster shot” for the immune system, which has been infected by HPV 16.
Some of the possible side effects include:
- Flu-like symptoms
According to investigators, earlier phases of the trial have showed a “12-month survival of nearly 39 percent in 26 patients have recurrent metastatic cervical cancer.” This is an improvement compared to previous rates of survival.