This trial is evaluating whether ADXS11-001 (ADXS-HPV) will improve 1 primary outcome and 1 secondary outcome in patients with Squamous Cell Carcinoma of the Head and Neck. Measurement will happen over the course of Assessed up to 3 months after surgery.
This trial requires 15 total participants across 2 different treatment groups
This trial involves 2 different treatments. ADXS11-001 (ADXS-HPV) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
"Multiple factors seem to play a role in the development of carcinoma, squamous cell. Smoking, a physical alteration, may be a risk factor; the mechanism by which carcinoma develops is unknown. But the incidence of cancer is higher among the elderly, women, blacks, Hispanics, the poor, etc., suggesting the need to study certain gene-environment interactions in the carcinogenesis of different groups of cancers." - Anonymous Online Contributor
"The most common form of [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer) is squamous cell carcinoma (SCC), although melanoma is the most common form of melanoma in the US. Each year, about 32,000 new diagnoses of SCC will be made in the US. This makes SCC the most common form of skin cancer in the US, and it is the second most common form of cancer for men, behind prostate cancer." - Anonymous Online Contributor
"Squamous carcinoma is one of the most common types of lung cancer. Males are afflicted with the disease two to three times as often as females. The disease is diagnosed in about 35% of individuals undergoing lung cancer surgery in the USA. Squamous cell carcinoma is more likely to form in smokers. The most common types of lung cancers among American females are adenocarcinoma and squamous carcinoma. Adenocarcinoma in females is more common among individuals who are Native American or Native Hawaiian people. Adenocarcinoma typically arises in individuals who smoke. Squamous carcinoma is not associated with smoking. American Indian and Alaskan Native males are more likely to exhibit large cell carcinoma." - Anonymous Online Contributor
"Carcinoma, squamous cell of the colon or lung should not be confused with other non-small cell carcinoma of the lung. They usually require resection of the primary tumor when curative intent is a viable option. However, when the primary tumor is resectable, adjuvant chemotherapy has been shown to improve overall survival. Lymph node dissection may also influence survival, and should be done when applicable. There is no convincing evidence as a routine practice in the United States to recommend post-operative irradiation for squamous cell carcinoma of the lung. It is important to note, however, that there are many different types of lung cancer and the prognosis of one type may differ from the other types." - Anonymous Online Contributor
"In an era of effective radiotherapy, chemotherapy or a combination of the above, a cure is not likely nor have we seen anything that could be described as such. But the results from our series continue to be of interest. We believe that our series provides some balance regarding the importance of adjuvant radiotherapy in the treatment of carcinoma, squamous cell." - Anonymous Online Contributor
"Symptoms of carcinoma squamous cell include pain in the chest, trouble talking and swallowing, an abnormalt stupor, and a constant cough (dyspnea). Anorexia may also be present. Cervical lymphadenopathy, a palpable mass or pain on udny, is considered a sign of carcinoma squamous cell. Patients may also be at risk for pulmonary embolism (blood clots traveling to the lungs). On examination, a carcinoma squamous cell may be asymptomatic (have no symptoms) or may be painless with localized discharge from the urethra or urinary stasis." - Anonymous Online Contributor
"Adxs-HPV (adenosis, high-grade cervical intraepithelial neoplasia), when used in this dose and in conjunction with cervical cytology, is as safe as LEEP and is associated with similar rates of PDR." - Anonymous Online Contributor
"Clinical trial results demonstrate significant improvement in patient survival in patients receiving adxs11-001 compared with patients not in the intervention group. In addition, there were no significant differences between patients receiving adxs11-001 and those receiving placebo. Further results will determine if adxs11-001 has sufficient therapeutic benefit for additional study in patients with adxs11-001. ClinicalTrials.gov number, NCT00713182." - Anonymous Online Contributor
"Findings from a recent study demonstrated that no significant difference could be seen between the adxs-hpv and placebo groups but the study's duration was only 4 weeks which is short enough to measure the effect of the treatment. This is why we will need a long-term study to confirm the effects of the treatment." - Anonymous Online Contributor
"The 5-year survival rate for carcinoma, squamous cell was 64.2%, and the 10-year survival rate was 30.1%, which is lower than other studies for the last decade." - Anonymous Online Contributor
"The quality of life of cancer patients receiving adxs11-001 (i.m.; 50 mg/day) improves and maintains those scores during a 4-week period. There is an improvement in mental QOL as measured by global QOL and in all aspects of mental (mental subscales) and physical (physical subscale) QOL. There is also a significant improvement in patient-reported QOL with this adjunct therapy compared to placebo (p = 0.013). Adxs11 has a good safety profile since it is not associated with an increase in bleeding time, liver abnormalities, or other severe adverse effects." - Anonymous Online Contributor
"According to this study, the most common primary carcinomas in the adult age group were squamous cell carcinoma (38%) and adenocarcinoma (17%). We recommend that if squamous cell carcinoma is found from this study, then it should be followed by squamous cell carcinoma (SCC) to be cured early. Thus SCC can be treated at the earliest." - Anonymous Online Contributor