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Slovenian Woman Receives Treatment

Slovenian Woman Travels to St. Luke's Cancer Center to Receive Treatment for Advanced Melanoma with Dr. Agarwala

Madja Rauh (center) of Slovenia traveled
to  Bethlehem with her daughter Ursa Rauh
to receive treatment with internationally
recognized melanoma investigator Sanjiv
Agarwala, MD, of St. Luke's Cancer Center.

Watch the amazing story on WFMZ-TV.

Bethlehem, PA (12/16/2010)
Madja Rauh recently traveled to Bethlehem with her daughter Ursa Rauh from Ljubljana, the capital of Slovenia in Europe, to receive a promising, experimental treatment for metastatic melanoma with internationally recognized melanoma investigator Sanjiv Agarwala, MD, Chief of Medical Oncology and Hematology, St. Luke's Hospital & Health Network.

Melanoma is the deadliest form of skin cancer and, currently, there are no approved treatment options for those patients who have received prior treatment for the disease.

Benefits of PV-10

On Tuesday, December 14, 2010, Rauh received her first injection of PV-10, which is a proprietary formulation of Rose Bengal developed by Provectus Pharmaceutical, a development-stage oncology and dermatology biopharmaceutical company, based in Knoxville, Tennessee. Dr. Agarwala served as the principal investigator for Phase II of the PV-10 clinical trial in Bethlehem.

Research has shown that PV-10 is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis, according to Dr. Agarwala. Earlier this year, new positive data illustrated potential systemic benefit from PV-10 ablation of cutaneous melanoma lesions in people with advanced disease. Dr. Agarwala presented the findings at the world's leading cancer conference, the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois in June.

“PV-10 is appropriate for patients who have advanced disease and who have not benefited from other forms of treatment,” says Dr. Agarwala. “Madja is eligible for the compassionate use arm of the PV-10 trial since she has had multiple other surgeries and treatments only to have repeated recurrence of disease.”

Rauh learned she had melanoma in 1995 when she discovered a lesion on her right thigh. She had this surgically removed at the time and showed no signs of disease for eight years. Then, in June 2003, the melanoma returned. During the next seven years she endured more than 32 surgeries and limb perfusion in which high-dose chemotherapy is administered directly at the site, only to experience recurrence of the disease.

Dr. Agarwala Referred by San Francisco Clinic

Looking for new hope, Rauh traveled to a melanoma center in San Francisco about a month ago. The clinic there referred her to Dr. Agarwala for treatment. “I went home for three weeks and made arrangements to come see Dr. Agarwala,” she said.

Rauh recalls an incident that may have contributed to her melanoma when she was just 16. “I had been seaside for two months,” she says. “I remember a mark that remained from a small blister I developed that summer. When I turned 42, that same mark changed in shape and color and started to itch. It turned out to be melanoma and I had surgery to cut it out. I was fine for the next eight years.”

Then, in 2003, a lymph node taken from her groin area showed recurrence of disease. “That's when all the surgeries started,” she said. “I was developing new lesions, many of them, under the skin that were difficult to cut out. I knew I needed to do something. After a lot of research on the Internet to find something else, I came here to the United States.”

Since her initial PV-10 injection Rauh has not reported any problems and is in good spirits. “I feel good,” she says. Rauh will return home on Monday, December 20. “Her oncologist in Ljubljana will monitor her care there,” says Dr. Agarwala. “If needed, she will return to Bethlehem in eight weeks to receive her second injection of PV-10.”

Additionally, in June 2010, St. Luke's Cancer Center became the only hospital in Pennsylvania to participate in the Compassionate Use Trial with Ipilimumab, a drug that was shown to boost survival in a major study of people with previously treated metastatic melanoma. Significantly, the Phase 3 study was the first melanoma trial ever that has demonstrated prolonged survival.