Randomized, double-blind, multicenter two-stage adaptive Phase 3 study of intravenous administration of Reolysin® (Reovirus Type 3 Dearing) in combination with Paclitaxel and Carboplatin versus the chemotherapy alone in patients with metastatic or recurrent squamous cell carcinoma of the head and neck who have progressed on or after prior platinum-based chemotherapy
ID Number 12-0282Principal Investigator(s)
Krzysztof J. Misiukiewicz
Department(s) or Division(s)
Hematology and Medical Oncology
You may qualify to participate in this research study because you have squamous cell carcinoma of the head and neck which may have spread to other places in your body or has come back and your cancer has progressed while you were on or within 190 days of completing a platinum chemotherapy previously.
The purpose of this study is to evaluate if the treatment with the most common chemotherapy treatment (paclitaxel, carboplatin) with the experimental drug REOLYSIN® is more helpful in treating your type of cancer than using the chemotherapy treatment alone. An experimental drug is one that has not yet been approved for use by the U.S. Food and Drug Administration (FDA).
REOLYSIN is a new form of cancer treatment that uses a type of virus called Reovirus. This virus is commonly found in natural situations throughout the world (such as ponds and ditches) and is associated with only very minor chest infections or stomach upsets in humans.
A virus is easily passed from one person to another especially when their ability to fight infection is weakened, i.e. the elderly, babies or people with certain chronic illnesses.
In this study, REOLYSIN® or a placebo (a product that looks like REOLYSIN® but is a non active safe substitute) will be given through a small plastic tube into your vein (intravenous infusion) and you will also be treated with both paclitaxel and carboplatin in the same way. The dose of virus or placebo and chemotherapy you will receive could stay the same during the time you are on this study or could vary according to changes in your weight or if you experience side effects that require lowering the dose. A placebo is being used so that the researchers will be able to compare patients that receive REOLYSIN® with patients that receive the placebo to see if there is a difference in the two groups. Everyone will receive the paclitaxel and carboplatin which is a common treatment for squamous cell carcinoma of the head and neck.
Recruiting Patients: Yes