Clinical Trial Review
March 2016 | Volume 15 | Issue 3 | Feature | 364 | Copyright © 2016
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.
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Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer
Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. This pilot clinical trial studies the side effects and how well, before surgery, cetuximab works in treating patients with skin cancer that forms, grows, and spreads quickly and has spread from where it started to nearby tissue or lymph nodes. Giving cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
The primary objectives are to assess the response rate of cetuximab by Response Evaluation Criteria in Solid Tumors criteria in patients with advanced squamous cell carcinoma of skin (SCCS), and whether neoadjuvant cetuximab given in this patient population is both safe and feasible. Some secondary objectives are to measure the progression-free and overall survival of patients with advanced SCCS who receive neoadjuvant cetuximab, and to determine the conversion to resectability of patients treated with neoadjuvant cetuximab.
Cancer Risk in Carriers of the Gene for Xeroderma Pigmentosum
This study will determine if family members of patients with xeroderma pigmentosum (XP) have various abnormalities including: skin abnormalities; nervous system abnormalities, such as hearing problems; skin, eye, or internal cancers; or other changes. XP is a rare inherited disease that involves an inability to repair damage to cell DNA (genetic material). It can affect several organ systems, including the skin, eye, nervous system, and bones. Patients have a more than thousand-fold increase in frequency in all major skin cancers.
Parents of patients with XP are carriers of the abnormal XP gene. Other family members may also be carriers of the abnormal XP gene. Carriers do not develop the disease themselves; symptoms develop only in children who have inherited the faulty gene from both parents. This study will try to clarify the genetic basis for XP and to understand the increased frequency of cancer in the disease.Both XP patients who have been evaluated at the National Institutes of Health Clinical Center and their relatives are eligible for this study. Newly diagnosed XP patients are also eligible. Spouses of relatives will also be included as control subjects.
Open-label Pilot Study of Abatacept for the Treatment of Vitiligo
Vitiligo is a chronic autoimmune disease with evidence of CTLA-4 involvement. This pilot study of the treatment of new onset or actively progressing vitiligo with abatacept is to determine if weekly self-injections of medication lead to clinical improvement in vitiligo lesions. Abatacept has been shown to decrease T-cell activity and reduce symptoms associated with rheumatoid arthritis. Similar pathways have been shown to be involved in vitiligo. Therefore, 10 adult patients with active vitiligo who meet specific inclusion and exclusion criteria will be recruited to receive self-administered injections of abatacept weekly, starting at week 0 and continuing until week 24. A week 32 follow-up visit will also be performed to evaluate secondary endpoints. Patients will be monitored to see if skin lesions of vitiligo stop spreading and start to repigment with continued treatment.