Clinical Trials & Research in Skin Cancer
Recent Stanford Research Breakthroughs
The Stanford Melanoma Program offers clinical trials for treatment of advanced melanoma. Stanford is an active participant in the Eastern Cooperative Oncology Group (ECOG)multicenter clinical trials for melanoma, and a number of studies are open for patients with regional nodal metastasis and disseminated disease. Collaboration with our premier basic science departments will continue to provide new techniques and insights in the diagnosis and treatment of melanoma.
Physicians at the Stanford Skin Cancer Program are involved in clinical trials which allow patients access to treatments not yet available elsewhere.
Stanford melanoma and nonmelanoma skin cancer specialists are involved in the following ongoing research efforts:
- Innovative chemoprevention trials for melanoma which involve strategies to prevent the development of cancer in high-risk individuals, including a recently completed trial studying the use of a non-steroidal anti-inflammatory agent (similar to ibuprofen) in patients with atypical moles. Active chemoprevention research for melanoma and non-melanoma skin cancers (basal cell and squamous cell carcinomas) is ongoing.
- Collaboration with epidemiologists at the Cancer Prevention Institute of California and to develop greater understanding of melanoma incidence and mortality among individuals with different racial-ethnic and socioeconomic backgrounds.
- Discovery that interferon signaling defects in the immune system are common in patients with melanoma and other cancers (breast and gastrointestinal) and likely represent a common cancer-associated mechanism of immune dysfunction, which prevents cancer eradication in the host.
- Stem cell research and identification of genetic alterations and pathways of melanoma development to provide powerful therapeutic options for patients diagnosed with all stages of melanoma.
- Development of a novel study to test whether ipilimumab combined with radiation therapy enhances the body's ability to fight off metastatic melanoma – even outside of the radiation field
- Participation in a national ECOG clinical trial assessing the use of a KIT (a proto-oncogene) inhibitor in patients with advanced acral, mucosal and sun-induced melanomas.
- Participation in a national ECOG trial assessing the novel immunotherapy agent, ipilimumab, compared with high-dose interferon as adjuvant in resected stage III and IV melanoma. Further testing and use of a new class of agent, hedgehog pathway inhibitors, in basal cell carcinoma patients, including using a class of oral HPIs called smoothened inhibitors, for locally advanced and metastatic basal cell carcinomas.
- Research utilizing the common anti-fungal drug, itraconazole, which has activity as a hedgehog pathway inhibitor for patients with BCC.
- Preclinical studies with Bristol-Meyers-Squibb and Cephalon on targeting processed domains of laminin-332 in the development of antibody therapy for squamous cell carcinoma.
Currently Enrolling Clinical Trials for Melanoma and Nonmelanoma Skin Cancers
Melanoma
A PHASE III, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED STUDY OF VEMURAFENIB (RO5185426) ADJUVANT THERAPY IN PATIENTS WITH SURGICALLY RESECTED, CUTANEOUS BRAF-MUTANT MELANOMA AT HIGH RISK FOR RECURRENCE
Purpose: To evaluate the efficacy of vemurafenib adjuvant treatment, versus placebo, given over a 52-week period in patients with completely resected BRAF V600 mutation-positive melanoma for assessment of disease-free, distant metastasis-free and overall survival. Eligible patients include those with completely resected stage IIC cutaneous melanoma (>4 mm, ulcerated), IIIA melanoma (one or more sentinel lymph node metastasis >1 mm in diameter), or stage IIIB melanoma (for cohort 1); and stage IIIC melanoma (for cohort 2). Patients must have their tumor tested for BRAF mutation by a specific test known as the Cobas assay.
A Phase I/II Study of Intratumoral Injection of Ipilimumab in Combination with Local Radiation in Melanoma, Non-Hodgkin Lymphoma and Colorectal Carcinoma (VAR0090)*
Purpose: To demonstrate that ipilimumab (an antibody targeting CTLA-4) immunotherapy can be delivered directly into the tumor and combined with local radiation therapy to the injected tumor. In melanoma models, this combination local therapy results in systemic tumor shrinkage. The trial will determine safety and feasibility of this approach, as well as the systemic immune and clinical response rate.
Please contact Dr. Holbrook Kohrt at kohrt@stanford.edu for additional information regarding this trial.
A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon Alfa-2b for Resected High-risk Melanoma (ECOG1609)
[Purpose: To examine whether postoperative adjuvant ipilimumab or high-dose interferon α-2b can improve disease-free and overall survival in patients with resected high-risk melanoma (stage IIIB, IIIC, or IV [M1a, M1b]). To evaluate the recurrence-free and overall survival in patients randomized to receive postoperative adjuvant ipilimumab given at either 10 mg/kg (high dose) or 3 mg/kg (low dose) versus those randomized to receive high-dose interferon α-2b.]
A Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas (ECOG2607)
[Purpose: To estimate the objective tumor response rate in patients with unresectable locally advanced or metastatic acral, mucosal, or solar melanoma treated with dasatinib monotherapy. Metastatic tumor blocks are required for the evaluation of KIT mutations or amplifications, which are necessary for study eligibility Brain metastasis patients with stable disease are eligible. Ocular melanoma is excluded.]
A Pilot Study of Ipilimumab in Subjects with Stage IV Melanoma Receiving Palliative Radiation Therapy (MEL0005)*
[Single institution pilot study of ipilimumab combined with palliative radiation therapy (RT) in patients with Stage IV melanoma. Subjects can be treated first line or after any prior therapy (unless they had unacceptable toxicity on ipiliumab which required discontinuation) and must need palliative RT. The primary objective of the study is to assess the safety of combining ipilimumab with palliative RT in patients with Stage IV melanoma. Secondary objectives are: 1) to assess the induction of anti-melanoma immune responses using laboratory correlative studies of T cell responses to melanoma antigens, and 2) to compare tumor response rates and duration of responses in non-irradiated tumor sites in patients with Stage IV disease treated with ipilimumab alone.]
For further information, please contact study coordinator Lei Shura lshura@stanford.edu, 650-723-2312.
A Pilot Study of Vitamin D supplements for reduction of melanoma-associated genes in women (SKIN0010)*
[Single institution pilot trial to study vitamin D for prevention of melanoma. Our analysis of data from the Women’s Health Initiative demonstrated that women at high risk for melanoma (by virtue of nonmelanoma skin cancer history) had a 50% reduction in melanoma risk if they took vitamin D versus placebo (Journal of Clinical Oncology 2011). We are now studying the gene changes associated with vitamin D (4,000 IU daily) supplementation in moles from high-risk women.]
For further information, please contact study coordinator Irene Bailey-Healy baileyhi@stanford.edu, 408.892.7261
Basal Cell Carcinoma (BCC)
The Basal Cell Carcinoma Research Group at Stanford is leading several clinical studies to assess novel therapies for non-melanoma skin cancers. Stanford Dermatology clinical-investigators and basic scientists conducted pivotal research in the use of the recently FDA-approved drug, vismodegib, for patients with advanced basal cell carcinoma, including those with inoperable tumors and metastatic disease. This drug stems from basic research on the hedgehog pathway at Stanford over the past 14 years and is the first drug in a new class of anti-tumor agents.
Anne Chang MD, director of clinical trials in the Stanford Dermatology Department, spearheads several clinical studies to assess novel therapies for non-melanoma skin cancers. In conjunction with Drs. Anthony Oro and Jean Tang of Stanford Dermatology, a novel class of drugs, termed Smoothened inhibitors, is being studied for use in basal cell carcinomas, the most common human cancer worldwide. Ongoing studies for locally advanced, metastatic and inoperable basal cell carcinomas are in progress, and our BCC specialists are studying mechanisms of drug resistance in basal cell carcinomas. Please see Clinicaltrials.gov for additional information. The currently enrolling studies are as follows:
A phase 2 randomized double blind study of efficacy and safety of two dose levels of LDE225 in patients with locally advanced or metastatic basal cell carcinoma (SKIN0009)
A pilot open label study to examine the safety and efficacy of oral LDE225 in patients with locally advanced or metastatic basal cell carcinoma who have previously treated with non-LDE225 Smoothened inhibitors*
A phase 2 multicenter open label two cohort trial evaluating the efficacy and safety of GDC0449 in operable basal cell carcinoma (SKIN0007)
Please contact Dr. Chang at 650-721-7151 or alschang@stanford.edu for additional information regarding these BCC studies.
Phase II Biomarker Trial to evaluate the efficacy of itraconazole (oral antifungal agent) in patients with basal cell carcinoma (SKIN0004)*
[Itraconazole is an FDA-approved anti-fungal drug which has recently been shown to inhibit the Hedgehog signaling pathway responsible for BCCs. We are now testing itraconazole for shrinkage and prevention of BCCs.]
For further information, please contact study coordinator Irene Bailey-Healy baileyhi@stanford.edu, 408.892.7261
Learn more about active Skin Cancer and Cutaneous Lymphoma clinical trials.
* highlighted studies are Stanford investigator initiated
Trial Administration