New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma...
Skin NeoplasmsCarcinoma1 moreBasal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a slow-growing tumour which despite low metastatic potential may cause significant local tissue destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week apart. This procedure is considered quite time- and resource-consuming. Introducing a single treatment session, with a new PDT session for treatment failures after 3 months, might represent an attractive simplification. This randomised controlled single-blinded multi-centre study primarily aims to compare BCC lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard Metvix(R) PDT treatments 1 week apart. Secondary objectives are to investigate the treatment response in relation to clinical and histological tumour characteristics such as tumour thickness, subtype and immunohistochemical markers.
VISmodegib for ORbital and Periocular Basal Cell Carcinoma
CarcinomaBasal CellBasal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat. Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in which the Hh signaling pathway appears to contribute to the development and maintenance of tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for treatment of metastatic and locally advanced BCCA. Recent reports have suggested that vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is eventually required In order to assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular BCCA, this study will follow patients with globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with vismodegib as standard of care. Patients with tumors that do not respond to treatment with Vismodegib, and those who have a good response but poor tolerance of Vismodegib, will be offered surgical excision of the tumor. Patients with a good response and good tolerance of Vismodegib may continue the treatment as long as clinically indicated.
Intron-A/Aldara Combination Therapy for Basal Cell Carcinoma (BCC)
Basal Cell CarcinomaA trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara.
Cancer Risk in Carriers of the Gene for Xeroderma Pigmentosum
Xeroderma PigmentosumBasal Cell Carcinoma3 moreThis 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. XP patients who have been evaluated at the NIH 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. Patients and their family members will undergo some or all of the following procedures: Parental permission to review the child s relevant medical records and pathology material from treatments or surgery for cancer or other related illnesses Medical history and physical examination, with particular attention to the skin and possible eye, hearing or neurological examinations Photographs to document skin and other physical findings Nuclear medicine scans to evaluate the brain and nervous system X-rays of the skull or other parts of the body Nervous system testing with an electroencephalogram (EEG), electroretinogram (ERG), electromyogram (EMG) or nerve conduction velocity measurement Collection of blood and skin samples for gene studies Establishment of cell lines from collected blood or tissues to study DNA repair, skin cancer, cancers related to XP, immune defects, and related studies. Biopsy (surgical removal of a small piece of tissue) of suspicious skin lesions for examination under a microscope Collection of a cheek cell sample, obtained by twirling a soft brush against the inside of the cheek Collection of a hair sample for microscopic examination and composition analysis Surgery to treat skin cancers or other lesions
Effect of the Subconscious on Mohs Micrographic Surgery
Basal Cell CarcinomaSquamous Cell CarcinomaThe goal of this study is to determine if relaxation therapy improves patient satisfaction with Mohs micrographic surgery.
Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell...
Nodular Basal Cell CarcinomaThe primary objective is the observation and description of the preliminary efficacy of resiquimod gel 0.06% on a single nodular basal cell carcinoma (nBCC) in a small group of patients.
T4N5 Liposomal Lotion in Preventing The Recurrence of Nonmelanoma Skin Cancer in Patients Who Have...
Actinic KeratosisBasal Cell Carcinoma of the Skin2 moreThis randomized phase II trial is studying how well T4N5 liposomal lotion works in preventing the recurrence of nonmelanoma skin cancer in patients who have undergone a kidney transplant. Chemoprevention therapy is the use of certain drugs to try to prevent the development of or recurrence of cancer. T4N5 liposomal lotion may be effective preventing the recurrence of nonmelanoma skin cancer in patients who have undergone a kidney transplant.
Reflectance Confocal Microscopy in Basal Cell Carcinoma
CarcinomaBasal CellSkin cancer is the most common cancer and its incidence is increasing rapidly. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type. In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be assessed at the first consultation in a non-invasive way and the patient can be treated instantly. Overall, the aim of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma. Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and excision.
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis...
Adult Giant Cell GlioblastomaAdult Glioblastoma43 moreThe purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. The uptake of the novel radiopharmaceutical 18F-FPPRGD2 will be assessed in study participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC) who are receiving antiangiogenesis treatment.
PDT With Metvix® 160 mg/g Cream in Organ Transplant Recipients With Non-melanoma Skin Cancer
Actinic KeratosisWarts3 morePatients on immunosuppressive therapy, e.g. organ recipients, have a higher occurrence of AK than the untreated population. Keratotic lesions (i.e. AK lesions and warts) in this population is highly associated with development of SCC also with 10 times higher mortality rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and BCC, increases with graft survival time and the length of immunosuppressive treatment period. The higher risk of developing skin malignancy and more aggressive skin malignancies in this population, indicate the need for early removal of these pre-malignant lesions. In this study, two contralateral areas (5x10 cm2) with skin lesions within the patient will be compared. One area will receive Metvix PDT at defined intervals and the other will receive lesion specific treatment at the discretion of the investigator. The primary end-point will be the accumulated number of new lesions during the study and number of AK lesions that show complete response 3 months after baseline. Secondary endpoints will be number of BCC lesions that show complete response, number of recurrent lesions, assessment of cosmetic outcome and safety.