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Novel clinical study seeks advanced melanoma patients.

Scientists are now recruiting patients for a clinical trial to investigate a promising new treatment for advanced melanoma. When caught early, malignant melanoma is curable in over 90% of cases. (1) However, once melanoma spreads (metastasizes) to other body tissues, the prognosis is grim, making it the deadliest form of skin cancer. A novel treatment method called in situ photo-immunotherapy (ISPI) has produced impressive results in all patients in whom it has so far been tested. (2)

Immunotherapy--stimulating the body's own immune system to recognize and destroy cancerous cells--is considered one of the most promising ways to treat advanced forms of the disease. ISPI may improve on this approach, as it enlists patients' specialized defensive cells and sensitizes them to the patient's specific tumor characteristics. ISPI makes use of an immune-stimulating, topically applied skin cream used in conjunction with infrared lasers. The topical cream, imiquimod (Aldara[TM]), binds with receptors on tumor cells and stimulates them to activate proteins that "broadcast" the presence of the tumor cells to the immune system. In essence, the patient's own tumor cells become a unique anti-tumor vaccine.

A preliminary case report examined the use of ISPI in two patients with late-stage melanoma. Following a six-week treatment cycle, both patients are still alive--more than 30 months later in one case, and 18 months later in the second case. The median life expectancy for stage IV melanoma cases is typically six to eight months. In addition, researchers observed shrinkage of untreated systemic metastases following therapy in at least one subject. (2) These preliminary findings indicate that ISPI therapy may be a useful and relatively non-toxic way to treat patients with advanced melanoma.

Based on these findings, ISPI has received investigational new drug status from the FDA. Researchers at the University of Oklahoma are recruiting patients with stage III or IV melanoma for a clinical trial assessing ISPI's effectiveness in treating advanced-stage melanoma. All stage III and stage IV melanoma patients who enroll will receive the treatment. Prospective subjects must have at least one qualifying melanoma lesion (an unresected cutaneous metastasis), be willing to travel to Tulsa for the treatment cycle (five visits over a two-month period), and have a life expectancy of at least four months, even without therapy.

Patients accepted for the clinical trial will apply imiquimod cream twice a day to a specified area of the skin, for a total of six weeks. At weeks two and four, investigators will expose the area to an infrared laser, which is expected to enhance the effectiveness of the topical cream.

"The goal of the treatment is to stimulate significant anti-tumor host immune responses to palliate metastatic disease and potentially prolong life," notes co-principal investigator Dr. Mark Naylor. Dr. Naylor hopes to enroll at least 20 stage IV and 50 stage III melanoma patients for the trial. To inquire about participating in this study, contact:

* Lisa Perry, MA, Dermatology Clinic

* 918-743-6675 (office)

* 918-743-4821 (FAX)

* Lin Peabody, LPN, CCRC, Department of Surgery

* 918-660-3931 (office)

* 918-660-3833 (FAX)

* Email: Linda-Peabody@ouhsc.edu

* University of Oklahoma College of Medicine, Tulsa, OK

Reference

(1.) Available at: http://www.skincancer.org/melanoma/index.php. Accessed February 8, 2007.

(2.) Naylor MF, Chen WR, Teague TK, Perry LA, Nordquist RE. In situ photoimmunotherapy: a tumour-directed treatment for melanoma. Br J Dermatol. 2006 Dec;155(6):1287-92.
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Title Annotation:In The NEWS
Author:Kiefer, Dale
Publication:Life Extension
Article Type:Clinical report
Date:Apr 1, 2007
Words:552
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