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Carcinoma, Basal Cell clinical trials

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NCT ID: NCT02029352 Completed - Clinical trials for Carcinoma, Basal Cell

Topical Green Tea Ointment in Treatment of Superficial Skin Cancer

Start date: November 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Basal cell carcinoma (BCC) is the most frequently occurring nonmelanoma skin cancer in Caucasians, representing approximately 80% of cases. Incidence rates for men and women in the Netherlands are 165 and 157 per 100,000 person-years respectively and are still rising 3-10% annually. In 2009, the lifetime risk for developing a first histologically confirmed BCC for men was approximately 1 in 5 (21%) and for women it was 1 in 6 (18%). A simplified classification of BCC includes the following three histological subtypes: nodular (40,6), superficial (30,7%) and infiltrative BCC (28,7%). Superficial BCCs (sBCCs) differ from the other subtypes as they tend to appear at a younger age, usually occur on the trunk and are often multiple. This subtype has the fastest growing incidence. A characteristic feature of BCCs is their low risk to metastasize, though if untreated they may induce considerable functional and cosmetic morbidity as they are locally invasive. Surgery is the first treatment of choice for BCC. However due to the rising incidence and the extensive workload this entails, a non-invasive topical treatment is often chosen for sBCC as they grow down from the epidermis into the superficial dermis and therefore are easily accessible for topical treatment. Photodynamic therapy (PDT), imiquimod cream or 5-fluorouracil cream are available topical treatments for sBCC however their tumour free survival rates are not equal to the higher tumour free survival rates of surgical treatment. Next to the efficacy, the now available topical treatments are associated with local skin reactions at the treatment site, mainly erythema and erosion (imiquimod cream and 5-fluorouracil cream) or pain and burning sensation (PDT). This creates the need for additional or alternative non-invasive topical treatments. The active constituents of green tea are promising as they are supported to have anti-BCC-carcinogenesis effects by several epidemiological, cell culture and animal studies. The so-called polyphenols known as catechins are the active constituents of green tea and the catechin epigallocatechin-3-gallate (EGCG) is the major and most active catechin. EGCG is thought to have a cytotoxic effect on skin cancer cells and has the availability of inhibition of cell growth and induction of apoptosis. It is also suggested that EGCG plays a role in inactivation of β-catenin signalling, an important component of the WNT pathway. Sinecatechins 10% ointment (Veregen®) is a standardized extract of green tea leaves of the species Camellia sinensis, containing mainly green tea polyphenols, particularly catechins (more than 85%). The lead catechin in sinecatechins ointment is EGCG. It is approved by the US Food and Drug Administration (FDA) for genital warts in adults. There are no clinical trials on human subjects with topical EGCG on sBCC yet. With this trial we are the first to try to validate the anti-carcinogenic potentials of topical EGCG in humans with sBCC. We assess the effectiveness of sinecatechins 10% (Veregen®) versus placebo for the topical treatment of sBCCs.

NCT ID: NCT02018679 Completed - Clinical trials for Nodular Basal Cell Carcinoma

Er:YAG Ablative Fractional Laser Assisted-Photodynamic Therapy Versus Photodynamic Therapy for Basal Cell Carcinoma

Start date: March 2011
Phase: Phase 1
Study type: Interventional

Topical photodynamic therapy with methyl-aminolaevulinate (MAL-PDT) has been introduced as an alternatively attractive procedure for BCC. Er:YAG ablative fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no studies have directly compared the efficacy of Er:YAG AFL-PDT and MAL-PDT in treating nodular BCC in Asians.

NCT ID: NCT02017964 Completed - Medulloblastoma Clinical Trials

Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed, Non-metastatic Desmoplastic Medulloblastoma

Start date: December 24, 2013
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well combination chemotherapy works in treating younger patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

NCT ID: NCT02007317 Completed - BCC Clinical Trials

Safety and Efficacy of Oshadi D and Oshadi R in Basal Cell Carcinoma Patients Prior to Tumor Excision a Phase 2 Study

Start date: November 2013
Phase: Phase 2
Study type: Interventional

This study is single-arm, none randomized, open label, two-dose-cohorts, single center clinical trial for evaluation of the safety and efficacy of Oshadi D and Oshadi R in patients with BCC. Patients will receive Oshadi D and Oshadi R for 60 -90 days until the planned surgical excision of the lesion.

NCT ID: NCT01898598 Completed - Clinical trials for Basal Cell Carcinoma

A Study of Vismodegib With Surgery in Patients With Previously Untreated Basal Cell Carcinoma

Start date: February 2014
Phase: Phase 2
Study type: Interventional

This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in patients with basal cell carcinoma. Patients will be randomized to receive oral daily doses of vismodegib 150 mg or matching placebo. The anticipated time on study drug treatment is 12 weeks.

NCT ID: NCT01872130 Completed - Clinical trials for Squamous Cell Carcinoma

Reflectance Confocal Microscopy of Wounds During Moh's Surgery: Feasibility Testing of a Mosaicing Algorithm for Intraoperative Imaging of Cancer Margins

Start date: May 2013
Phase:
Study type: Observational

The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate assessment of surgical margins in the excision of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC). The investigators will evaluate the pictures obtained by the confocal microscope to determine whether this technique may be useful in the future for helping Mohs surgeons remove cancers. In the future, patients may benefit with shorter surgery and improved care.

NCT ID: NCT01835626 Completed - Skin Cancer Clinical Trials

Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma

Start date: May 2013
Phase: Phase 2
Study type: Interventional

Chemotherapy, radiation therapy, and surgery are standard treatments for basal cell carcinoma at most institutions. The purpose of this study is to determine whether adding vismodegib to radiation (chemoradiotherapy) is safe and tolerable. The purpose of this study is to assess the safety and tolerability of combined radiation therapy and vismodegib. This combination may increase the chances of the tumors being destroyed or unable to spread to other parts of the body in people with locally advanced basal cell carcinoma of the head and neck.

NCT ID: NCT01815840 Completed - Clinical trials for Basal Cell Carcinoma

A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

Start date: April 30, 2013
Phase: Phase 2
Study type: Interventional

This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.

NCT ID: NCT01806675 Completed - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy

Start date: March 4, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The 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.

NCT ID: NCT01791894 Completed - Clinical trials for Recurrent Skin Cancer

Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

ATO
Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This pilot clinical trial studies arsenic trioxide in treating patients with basal cell carcinoma. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stop them from dividing