G0265 A Phase II Evaluation of ADXS11-001 in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix
The purpose of this study is to find out if ADXS11-001 works in treating recurrent or persistent cancer of the cervix and to find out what side effects are caused by this drug. ADXS11-001 is intended to stimulate the immune system to respond to the human papillomavirus (HPV) and cervical cancer. HPV comes in over 100 different types; persistent HPV infections are known to be the major risk factor for invasive cervical cancer. This experimental drug is a modified and weakened version of a well-known bacterium called Listeria monocytogenes. This bacterium has been shown to stimulate the immune system and as a result, has the potential to be used to treat cancer. ADXS11-001 contains a unique DNA sequence of HPV, which is found in all cervical cancers.
- persistent or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix - measurable disease - normal lab values and good performance status - must have had one prior systemic chemotherapy regimen for advanced, metastatic, or recurrent disease - allowed to receive one additional regimen and allowed to receive prior biologic/targeted therapy
This is an all outpatient regimen. Women will receive an IV infusion of ADXS11-001 once every 28 days for a maximum of 3 doses. Women will be closely monitored and required to follow a strict schedule of oral medications at home.
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