clinical trial

Clinical trial gets oral cancer survivor through ‘mean’ cancer

Source: web.musc.edu Author: Leslie Cantu Brittany Person was reluctant to enroll in the clinical trial that her oncologist, John Kaczmar, M.D., recommended. Not because she was afraid of taking part in research, but because she just couldn’t deal with any more side effects. She'd already had every one in the book after being treated for a tongue cancer that had returned – and then returned again. “I was just coming off the tail end of chemo, where I had the worst side effects from the chemo and radiation. My body was just tired and beat up and scarred,” she said. When Kaczmar outlined the potential side effects of the investigational drug, she thought, “I just really don't want to do that again. That didn't sound like something I wanted to put myself through.” As she and her husband, Patrick Wilkin, drove from MUSC Hollings Cancer Center to Duke Cancer Institute for a second opinion, Person told Wilkin, “They need to tell me something crazy in order for me to do this trial.” That’s pretty much what they did. “The lady at Duke told me if I didn’t do anything, I would have six months to live,” Person said. “When we got the whole ‘six months to live’ talk, if you do nothing, or two years, if you do the standard immunotherapy, and that the experimental trial is your best shot at actually beating the thing, that's when Brittany and I were like, ‘Yeah, let's do this experimental trial,’” Wilkin said. [...]

Oral Cancer Foundation News Team - A2023-12-15T07:49:56-07:00December, 2023|Oral Cancer News|

Early phase clinical trial shows promise for advanced head and neck cancer

Source: www.fredhutch.org Author: Rachel Tompa / Fred Hutch News Service For many survivors of head and neck cancer, the disease — and its treatment — leave a lifelong, unmistakable mark. Surgeries to remove tumors in the mouth, neck or throat often leave patients with disfiguring scars and difficulty speaking or swallowing. Some may not even be able to perform these tasks at all. Carla Stone participated in a clinical trial run by Fred Hutch's Dr. Eduardo Méndez for her advanced head and neck cancer. The experimental approach shrank her tumor down to nothing, sparing her what is typically a disfiguring surgery.Photo by Robert Hood / Fred Hutch News Service When you look at Carla Stone, you might not guess that she was diagnosed with stage 4 head and neck cancer just two years ago. The only visible sign of her disease and treatment — and you have to know what you are looking for — is the tiny dot tattooed on her chest, the marker for the radiation she received to her throat. Stone, a 66-year-old bookkeeper from Monroe, Washington, had ongoing symptoms for nearly two years before her doctors finally detected the tumor that had been growing on the base of her tongue. Her primary care physician dismissed the lump in her neck she found in 2014, Stone said, and a series of doctors kept giving her different antibiotics for the chronic sore throat she developed in early 2016. Eventually, when the antibiotics didn’t work, Stone sought [...]

Oral Cancer Foundation News Team - A2018-04-16T10:14:23-07:00April, 2018|Oral Cancer News|

SciClone Pharmaceuticals Inc enrols first patient in Phase 2b trial of SCV-O7 for oral mucositis

Source: www.therapeuticsdaily.com Author: staff Specialist pharmaceutical company SciClone Pharmaceuticals Inc (NASDAQ:SCLN) revealed on Tuesday that the company has enrolled the first patient in its phase 2b clinical trial of SCV-07 for the prevention of oral mucositis (OM), a painful, debilitating and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer. The company said that the study will examine three doses of SCV-07, including two higher doses than those used in the recent phase 2a study, to assess the drug's impact on modifying the course of OM in patients with head and neck cancer. This multi-centre, randomised, double-blind, placebo-controlled study will enroll approximately 160 subjects who are receiving standard chemoradiation therapy for treatment of cancers of the head and neck. Subjects will be randomly assigned to one of the trial's four treatment arms: placebo and SCV-07 at doses of 0.1 mg/kg, 0.3 mg/kg and 1 mg/kg. According to the company, SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which appears to stimulate the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells.

Oral Cancer Foundation News Team - A2011-01-14T09:11:19-07:00January, 2011|Oral Cancer News|

Growth factor regenerates tooth supporting structures: Results of a large randomized clinical trial

Source: www.eurekalert.org Author: press release It is well known that oral infection progressively destroys periodontal tissues and is the leading cause of tooth loss in adults. A major goal of periodontal treatment is regeneration of the tissues lost to periodontitis. Unfortunately, most current therapies cannot predictably promote repair of tooth-supporting defects. A variety of regenerative approaches have been used clinically using bone grafts and guiding tissue membranes with limited success. In an article titled "FGF-2 Stimulates Periodontal Regeneration: Results of a Multicenter Randomized Clinical Trial," which is published in the International and American Associations for Dental Research's Journal of Dental Research, M. Kitamura, from Osaka University Graduate School of Dentistry, Japan, and a team of researchers conducted a human clinical trial to determine the safety and effectiveness of fibroblast growth factor-2 (FGF-2) for clinical application. This is the largest study to date in the field of periodontal regenerative therapy. A randomized, double-masked, placebo-controlled clinical trial was conducted in 253 adults afflicted with periodontitis. Periodontal surgery was performed, during which one of three different doses of FGF-2 was randomly administered to localized bone defects. Each dose of FGF-2 showed significant superiority over the standard of care (vehicle alone (p

Oral Cancer Foundation News Team - A2010-11-19T15:10:25-07:00November, 2010|Oral Cancer News|

UC cancer drug trials offer lone hope

Source: news.cincinnati.com Author: Peggy O'Farrell Two years ago this month, Pam Cain learned the bump on her tongue was really cancer. Last year, she learned the "bump" had spread to both lungs. "Last November, I was given two years if I only did chemo," she said. So she underwent radiation therapy. But the lesions on her lungs stayed put, and the cancer spread to one hip. So far, three chemotherapy combinations failed to kill her cancer. Now Cain, 32, of Union is hoping an experimental targeted therapy will knock out her cancer. She was the second patient in the United States to receive the experimental drug, and one of about five patients now enrolled in four clinical trials for new cancer therapies at the University of Cincinnati. The phase 1 trials are part of UC's effort to raise its profile for cancer treatment and research. Phase 1 trials are the earliest stage of testing new medications or medical devices on humans. They're designed to determine if a new treatment is safe, not whether it works. For patients like Cain, who have run out of tried-and-true options, it means being able to get cutting-edge treatments close to home. "This way, I didn't have to leave my kids," she said. "I didn't have to travel. I didn't have to go someplace where I didn't know anybody. And financially, it would have hurt." For the researchers and physicians who conduct the trials, it's an opportunity to help find the next wonder drug. Olivier [...]

Oral Cancer Foundation News Team - A2010-11-07T09:41:21-07:00November, 2010|Oral Cancer News|

Office-based ultrasound-guided FNA found to be superior in diagnosing head and neck lesions

Source: American Academy of Otolaryngology Author: Jessica Mikulski Office-based, surgeon-performed, ultrasound-guided, fine needle aspiration (FNA) of head and neck lesions yields a statistically significant higher diagnostic rate compared to the standard palpation technique, indicates new research in the March 2010 issue of Otolaryngology - Head and Neck Surgery. FNA is a diagnostic procedure used to investigate superficial lumps or masses. In this technique, a thin, hollow needle is inserted into a mass to extract cells for examination. FNA biopsies are a safe minor surgical procedure. Often, a major surgical (excisional or open) biopsy can be avoided by performing a needle aspiration biopsy instead. FNA biopsies in the head and neck have also proven to be an invaluable tool in establishing the diagnosis of lesions and masses from a broad range of sites, including the thyroid, salivary glands, and lymph nodes. The efficacy of ultrasound-guided FNA has been well documented in many areas of the body, leading to its acceptance as the standard of care among radiologists and many cytopathologists. However, while the utility of ultrasound in the head and neck is widely appreciated and employed by the radiology community, clinicians in the United States have not embraced office-based ultrasound. The study authors sought to provide additional evidence and support for this procedure in order to ensure appropriate use by the clinical community. In this randomized, controlled trial of 81 adults, researchers divided participants into two groups, using either ultrasound-guided or traditional palpation-guided FNA to evaluate an identified head and neck mass. [...]

Charlotte Parker2010-03-11T18:54:05-07:00March, 2010|Oral Cancer News|

Peregrine completes patient enrollment in bavituximab trial

Source: www.pharmaceutical-business-review.com Author: staff Peregrine has completed the patient enrollment in its US Phase I clinical trial, evaluating bavituximab as monotherapy in patients with advanced refractory cancers. The objectives of this multi-center open label dose escalation study are: to determine the safety and tolerability of bavituximab in patients with advanced cancer, to characterize the pharmacokinetic profile of bavituximab, and to identify dose-limiting toxicities and the maximum tolerated dose and/or maximum effective dose. In these patients, a maximum tolerated dose had not been reached even at the highest planned dose level. Peregrine has now begun designing additional bavituximab cancer trials based on findings from this Phase I study, and its Phase II combination therapy trials in breast and lung cancer. The trial enrolled patients with breast, colorectal, pancreatic, liver, prostate, and head and neck cancers, as well as melanoma and mesothelioma. Joseph Shan, Vice President of clinical and regulatory affairs, Peregrine, said: "Completion of patient enrollment in this Phase I trial is a significant milestone for the bavituximab cancer program. We believe data from this study, along with our ongoing Phase II lung and breast cancer trials, set the stage for advancing the bavituximab oncology program into later-stage clinical studies.” “The safety data collected from the diverse cancer types in this study are encouraging as we plan for expansion of the bavituximab cancer program in the coming year. We look forward to sharing more data from the ongoing cancer trials as patient treatment and follow-up continue in this study and in [...]

Oral Cancer Foundation News Team - A2009-07-13T15:47:55-07:00July, 2009|Oral Cancer News|

Randomized clinical trial with two omega 3 fatty acid enhanced oral supplements in head and neck cancer ambulatory patients

Source: Eur Rev Med Pharmacol Sci, May 1, 2008; 12(3): 177-81 Authors: DA de Luis et al. The aim of our study was to investigate whether oral ambulatory nutrition of post surgical head and neck cancer patients with recent weight loss, using two different omega 3 fatty acids enhanced diets could improve nutritional variables as well as clinical outcome. A sample of 65 ambulatory post surgical patients with oral and laryngeal cancer and recent weight loss was enrolled. At Hospital discharge post surgical head and neck cancer patients were asked to consume two cans per day of either a specially designed omega 3 fatty acid enhanced supplement with a high ratio of omega3/omega6 (I) or a omega 3 fatty acid enhanced supplement with a low ratio of omega3/omega6 (II). Serum albumin, prealbumin and transferrin concentrations improved with both enhanced formula. Weight stabilization was reached with both formulas. Gastrointestinal tolerance (diarrhea episodes) with both formulas was good (6.45 vs 5.88%: ns). The postoperative infectious complications were similar in both groups (29 group I vs 15.7% group II: ns). No local complications were detected in surgery wound. In conclusion, at dose taken, omega 3 enhanced formulas with different omega3/omega6 ratios improved serum protein concentrations in ambulatory postoperative head and neck cancer patients with good tolerance. Authors: DA de Luis, O Izaola, R Aller, L Cuellar, MC Terroba, and T Martin Authors' affiliation: Institute of Endocrinology and Nutrition, Medicine School and Unit of Investigation Hospital Rio Hortega, University of Valladolid, Valladolid, Spain

Oral Cancer Foundation News Team - A2008-08-19T07:59:42-07:00August, 2008|Oral Cancer News|