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April 2007

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™), 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: [email protected]
  • University of Oklahoma College of Medicine, Tulsa, OK

—Dale Kiefer


1. Available at: 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.

Broccoli-Tomato Combo Reduces Prostate Tumors

A diet enhanced with tomato and broccoli powders helps shrink tumors in an animal model of prostate cancer, and is more effective than a diet supplemented with either vegetable extract alone, according to a recent report.*

In a study of rats with implanted prostate cancer tumors, the animals were divided to receive diets containing 10% broccoli powder, 10% tomato powder, or a combination of both. Other rats received lycopene or finasteride (a drug used to treat prostate enlargement), or were surgically castrated. After 22 weeks of treatment, rats that received broccoli and tomato powder experienced greater shrinkage of their tumors than animals in any other group.

“Older men with slow-growing prostate cancer who have chosen watchful waiting over chemotherapy and radiation should seriously consider altering their diets to include more tomatoes and broccoli,” the study authors noted.

—Dayna Dye


* Canene-Adams K, Lindshield BL, Wang S, Jeffery EH, Clinton SK, Erdman JW Jr. Combinations of tomato and broccoli enhance antitumor activity in dunning r3327-h prostate adenocarcinomas. Cancer Res. 2007 Jan 15;67(2):836-43.

Higher Vitamin D Levels Lower MS Risk

Higher serum levels of vitamin D are associated with a lower risk of multiple sclerosis among white—but not black or Hispanic—men and women, according to a recent report.* This new finding corroborates previous studies suggesting that vitamin D may have a protective effect against multiple sclerosis.

Harvard scientists used military disability databases to identify 257 people diagnosed with multiple sclerosis between 1992 and 2004. Each subject was then compared to two control subjects selected from the Department of Defense Serum Repository and matched for age, gender, and ethnicity.

For every 50-nanomole-per-liter increase in serum 25-hydroxyvitamin D among white subjects, there was a 41% decrease in the risk of multiple sclerosis. Whites in the top fifth of serum vitamin D concentrations had the lowest disease risk—62% lower than for those in the lowest fifth. Among black and Hispanic subjects, scientists found no association between serum vitamin D level and multiple sclerosis risk.

—Dayna Dye


*Munger KL, Levin LI, Hollis BW, Howard NS, Ascherio A. Serum 25-hydroxyvitamin D levels and risk of multiple sclerosis. JAMA. 2006 Dec 20;296(23):2832-8.

Folic Acid Improves Cognitive Function

Supplementing older adults with folic acid improves their cognitive function, according to recent findings published in the Lancet.*

Eight hundred eighteen subjects took either 800 mcg of folic acid or a placebo each day for three years. Participants were limited to those whose homocysteine levels were at least 13 and no greater than 26 micromoles per liter, and were tested for memory, sensorimotor speed, information processing speed, and word fluency at the study’s onset and conclusion.

In those who received folic acid, serum folate increased more than fivefold and plasma total homocysteine decreased 26% compared to the placebo group. Memory, information processing speed, and sensori-motor speed were also significantly improved in the supplemented group. Supplemental folic acid may thus be crucial for preserving cognitive function in older adults.

—Dayna Dye


* Durga J, van Boxtel MP, Schouten EG, et al. Effect of 3-year folic acid supplementation on cognitive function in older adults in the FACIT trial: a randomised, double blind, controlled trial. Lancet. 2007 Jan 20;369(9557):208-16.

Hormone Therapy May Lower Alzheimer’s Risk in Men

Androgen replacement therapy could help prevent the development of Alzheimer’s disease, report scientists in the Journal of Neuroscience.* Age-related depletion of testosterone, the primary male hormone, is a newly identified risk factor for Alzheimer’s.

Scientists castrated mice that were genetically modified to develop Alzheimer’s and administered dihydrotestosterone or a placebo for four months. At the end of the study, castrated mice that received placebo exhibited diminished working memory and elevated beta amyloid (a substance that develops in the brains of Alzheimer’s patients), compared to mice that were not castrated or received hormone therapy. The results suggest reduced testosterone levels may promote beta-amyloid accumulation in the brain.

“We’ve known that low testosterone is a risk factor for Alzheimer’s disease but now we know why,” wrote the scientists. “The implication for humans is that testosterone therapy might one day be able to block the development of the disease.”

—Dayna Dye


* Rosario ER, Carroll JC, Oddo S, LaFerla FM, Pike CJ. Androgens regulate the development of neuropathology in a triple transgenic mouse model of Alzheimer’s disease. J Neurosci. 2006 Dec 20;26(51):13384-9.

Vitamin C May Help Fight Obesity

Supplementing with high-dose vitamin C may offset weight gain associated with a high-calorie, high-fat diet, according to Spanish researchers.*

Since obesity is considered an inflammatory condition exacerbated by oxidative stress and excessive food intake, the researchers sought to determine whether a dietary antioxidant in sufficient quantities could mitigate inflammation and thus reduce obesity.

In the laboratory, they divided rats into three groups. One group received standard chow, a second group was free to choose from a cafeteria-style selection, and a third group ate cafeteria-style feed supplemented with high levels of ascorbic acid (vitamin C). After nearly two months, changes were assessed in the animals’ fat-cell genes. In rats fed ascorbic acid, vitamin C “was able to protect against high-fat-diet effects, reducing the increase of body weight, total body fat, and enlargement of different adipose deposits induced by the cafeteria diet,” the researchers concluded.

—Dale Kiefer


* Campion J, Milagro FI, Fernandez D, Martinez JA. Differential gene expression and adiposity reduction induced by ascorbic acid supplementation in a cafeteria model of obesity. J Physiol Biochem. 2006 Jun;62(2):71-80.

CoQ10 Aids Chronic Heart Failure Patients

Coenzyme Q10 supplementation improves cardiac function in patients with stable chronic heart failure, Italian researchers recently reported.*

Because plasma CoQ10 levels are depressed in patients with chronic heart failure, the scientists sought to determine whether oral CoQ10 supplementation could improve such patients’ prognoses. The four-phase, double-blind, placebo-controlled, crossover trial enrolled 23 male and female patients with stable chronic heart failure. In the first phase, patients received 300 mg of CoQ10 per day. In the second phase, they received the same dose of CoQ10 and supervised exercise training. In a third phase, subjects received placebo, and in the fourth, they received placebo plus exercise.

Oral CoQ10 improved the heart’s functional capacity, the ability of key blood vessels to dilate, and the contractility of the heart’s left ventricle in patients with stable chronic heart failure. CoQ10’s effects were even more pronounced when used in conjunction with exercise.

—Dale Kiefer


* Belardinelli R, Mucaj A, Lacalaprice F, et al. Coenzyme Q10 and exercise training in chronic heart failure. Eur Heart J. 2006 Nov;27(22):2675-81.

CLA and Exercise Improve Body Composition

Conjugated linoleic acid (CLA) and aerobic exercise produce additive improvements in body composition in young women, according to a recent report.*

Scientists divided a group of 44 healthy young women into four groups: exercise and CLA; CLA only; exercise only; and a control group. The two groups supplementing with CLA took 3.6 grams CLA per day, while the exercising groups participated in 30 minutes of aerobic activity, three times weekly for six weeks. At the study’s end, all three of the experimental groups had reduced their fat mass and waist and hip girth. The exercise-only and the exercise-plus-CLA groups both increased their lean body mass, while the CLA-only group reduced their body mass.

The scientists concluded that both CLA and aerobic exercise improve body composition, and that together they produce additive benefits.

—Elizabeth Wagner, ND


* Colakoglu S, Colakoglu M, Taneli F, Cetinoz F, Turkmen M. Cumulative effects of conjugated linoleic acid and exercise on endurance development, body composition, serum leptin and insulin levels. J Sports Med Phys Fitness. 2006 Dec;46(4):570-7.