The Gynecologic Oncology Group (GOG), a US-based national non-profit organization, is conducting a randomized Phase II trial of weekly paclitaxel versus weekly paclitaxel with Reolysin in patients with persistent or recurrent, ovarian, fallopian tube or primary peritoneal cancer (GOG186H). This study has been approved and will be sponsored by the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. Although the connection between viruses and cancer regression was recognized in the early 20th century, it wasn’t until the recent development of advanced genetic engineering techniques that true progress has been made using virotherapy to attack and destroy cancer cells. Recently, we have shown the presence of an inflammatory process in the hippocampus of schizophrenic patients during psychosis. Female subjects of childbearing potential must test negative for pregnancy at screening and agree to use 2 forms of highly effective methods of birth control, or remain abstinent for the specified duration. This study will have a profound impact on the treatment of burn patients both at our own institution and throughout the country. Serious adverse events of interest will include all serious adverse events that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). As of January 2016 it is estimated to completed by March 2017 (with an estimated Primary Completion date in Sept 2016).
Oncolytic viruses refer to those viruses that are able to eliminate malignancies by direct targeting and lysis (killing) of cancer cells within the tumor, leaving non-cancerous cells unharmed. The study is double-blind randomized placebo-controlled trial. Have current or recent history of herpes zoster or simplex in the last 90 days prior to randomization, or history of herpes zoster, such as disseminated herpes zoster involving multiple dermatomes, ocular involvement, including herpes zoster involving the ophthalmic branch of the trigeminal nerve. For patients with rheumatoid arthritis (RA), this vaccine has great potential to provide improved quality of life by reducing the incidence and complications associated with zoster. Due to the underlying disease and/or treatments (e.g. “Synergistic antitumor activity of oncolytic reovirus and chemotherapeutic agents in non-small cell lung cancer cells”. And, with the first approval in 2005 of the oncolytic adenovirus H101 for human use in China, more sophisticated, safe and effective oncolytic viral therapies will inevitably be approved for the benefit of cancer patients, either as monotherapies, or for use in combination with currently marketed drugs and conventional therapies.
In fact, because of a higher overall absolute risk for zoster in RA, the vaccine yields a comparable or even greater absolute risk reduction to reduce the risk of shingles and post-herpetic neuralgia in an RA population as it does in the general population. However, the use of the zoster vaccine in RA patients is very low (< 5%), and less frequently used than for the general population. National guidelines from the Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) recommend a single dose of the zoster vaccine for all individuals age 60 or older, with the vaccine more recently gaining FDA-approval for administration to persons age 50 and older. While a large number of RA patients would otherwise be recommended to receive this vaccine on the basis of age, theoretical safety concerns related to vaccination likely explain the very low vaccination rates observed. (2008). Such contraindication stems from the theoretical safety concern that these individuals could develop a varicella-like infection from the vaccine virus strain. However, investigators hypothesize that this vaccine can safely be given in this setting, as no published data is available to suggest that these safety concerns are warranted. A growing body of observational data suggests that vaccinating RA patients receiving biologic therapies with this vaccine may in fact be safe. Moreover, and similarly with little or no evidence, the ACIP considers the vaccine safe and acceptable for patients using methotrexate at doses commonly used to treat RA (e.g.