Discussion of Phase I/II Study by Nat'l Ctr CAM (NIH)

Phase I/II Study of Stage III and IV Non-Small Cell Lung Cancer Patients Taking a Specific Dietary Supplement - Dr. Alexander Sun, Medical Director, Connecticut Institute of Aging and Cancer

Dr. Alexander Sun first used a combination of Chinese herbs and vegetables to treat the cancer of his mother, who was diagnosed in 1984 with non-small cell lung cancer.

Despite chemotherapy and radiotherapy, the cancer grew and metastasized until it was graded as a Stage IV cancer and conventional medicine could not fight the disease. Dr. Sun, a native of Taiwan who is fluent in Chinese, found a copy of a Chinese traditional medical textbook, Chinese Medicinal Herbs, and studied it thoroughly.

He learned where and how each herb grows, how to prepare it, what its properties are, whether it is toxic, and how it is used to treat disease. The book listed the right ways to use each herb, and Dr. Sun carefully analyzed all this information to prepare an herbal vegetable soup to boost his mother's immune system and shrink her tumor.

When the tumor was removed surgically in December 1985, the surgeon was impressed that although it was large, it was very well encapsulated, and that there was no cancer in the margins or lymph nodes. The surgeon told Dr. Sun he had never seen this kind of encapsulation in 30 years, and said there must be something about the Chinese herbal treatment that had led to this result.

Dr. Sun reported that his mother is still free of cancer 14 years later.

Dr. Sun then gave the same soup to a family friend who had three brain lesions, which subsequently shrank and then disappeared. Further research followed.

The team, which grew to include a number of researchers from Mount Sinai Medical Center, tested the soup in laboratory mice and determined that it had both immune-enhancing and tumor-reducing properties. They next were invited to the Czech Republic where a study on the use of Dr. Sun's SV soup in treatment of lung cancer patients again showed favorable results.

Later, many family friends were referred to the team.

Their medical records were obtained, and the team viewed their pathological slides and radiological reports. Of 18 such patients, many were unable to drink the soup for two months; already they were too sick, and they died.

But two Stage IV cancer patients who took the soup were in complete remission 15 months later. Seven of the patients are still alive after 60 months or longer. In many, but not all, of this group, the SV soup was used as an adjunct to surgery or other conventional modality.

The primary and/or metastatic tumors of 10 of the patients were surgically removed, and eight of those patients remain cancer-free, leading Dr. Sun to believe that the SV soup and surgical removal of a tumor may be the best approach in many cases. Radiotherapy also seems helpful when used with the SV soup, he said.

Dr. Sun concluded that the apparent success of his SV soup leaves many questions. Dr. Richard Fasy, a member of Dr. Sun's team, proposed a paradigm for a future 24-month clinical trial on 60 Stage IV NSCLC patients, using a randomized and double-blind design, with 30 patients receiving the active SV soup and 30 patients receiving a placebo.

(Dr. Sun detailed several difficulties, however, in preparing a placebo that looks and tastes like a Chinese herbal preparation but has no active medicinal components.)

XI. Discussion

The research team asked the panel's help in determining what its next step should be. From the discussion that followed, it became clear that Dr. Sun and his colleagues have talked with Massachusetts General Hospital, which has expressed interest in funding and conducting a 60-patient Phase III clinical trial.

Further discussion led the panel to caution Dr. Sun about carefully assessing the optimum dose (small patients seem to have done better than larger patients in the earlier studies, leading Dr. Sun to wonder whether a different dose should be recommended for larger patients) and developing a true placebo.

Furthermore, the panel believed that if dietary recommendations were made as well, these should be formalized as part of the Phase III study.

Dr. Fair suggested that SV soup might provide an ideal formula for use in a neoadjuvant setting. Prostate and colon cancer patients are often told to wait two months following biopsy before having surgery. He suggested conducting a study using these patients, in which the soup could be given to one group of patients and the placebo to another.

Histologic changes in tissue between the biopsy and the surgery could be studied. The consensus of the committee was that Dr. Sun's work should be moved along to a Phase III clinical trial. The committee debated whether to suggest that Dr. Sun follow established channels used to test conventional treatments, or whether a different course should be charted.

Complicating the debate is Dr. Sun's status as holder of a patent for the SV soup. Since he has a financial stake in the outcome of the Phase III trial, there was much debate about the extent to which he should be involved.

Many committee members said they believed his involvement was crucial. The committee agreed that the program staff will examine several mechanisms for moving the research forward and prepare a report for the committee to consider at its December 1999 meeting.

July 8-9, 1999 meeting of the Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM), National Center for Complementary and Alternative Medicine

Ann Fonfa's comments at this meeting

July 8-9, 1999

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