Early Phase Cancer Treatments Prove Promising

Cleveland, June 1, 2003: New cancer treatments, some developed in laboratories at University Hospitals of Cleveland and Case Western Reserve University, are showing early promise in hard-to-treat and recurrent cancers. Physicians and scientists of the Ireland Cancer Center presented findings of Phase I and II clinical trials at the annual meeting in Chicago of the American Society of Clinical Oncology (ASCO), attended by more than 20,000 cancer experts worldwide.

The Ireland Cancer Center research involves new therapies for skin lymphoma, multiple myeloma, and solid tumors in patients whose conditions are complicated by kidney and liver damage, according to Stanton Gerson, MD, division chief of hematology and oncology at UHC, and professor of hematology and oncology at CWRU.

“All of our trials involve drugs under development in cooperation with the National Cancer Institute,” Dr. Gerson says. “Our investigators wrote all of the protocols for these clinical trials. Some of our findings were unusual for early phase studies, suggesting clinical efficacy as well as safety.”

The findings presented at the ASCO meeting include:

A Phase I study of a two-drug combination for cutaneous (skin) lymphoma using a drug developed over a decade of research at UHC/CWRU, a drug designed to weaken cancer cells and make them less resistant to chemotherapy. The new drug, 06-benzylguanine, is combined with a topical chemotherapy agent, BCNU. This approach requires doctors to administer BCNU, a topical chemical cream, shortly after delivering 06-benzylguanine (BG) intravenously. The standard approach, using BCNU alone, required significantly higher doses of the chemotherapy agent with the risk of patients developed significant skin irritations and low blood counts. Adding BG to the treatment allows for much lower doses of drugs, less drug resistance, and reduced toxicity. Out of 12 patients treated, one was completely cleared of disease and eight patients experienced greater than 50% reduction in skin lesions, a remarkable response in an early Phase I trial.

When used alone, BCNU attaches to the DNA in the patient’s cancer cells during the replication process, causing the cancer cells to die. Problems sometimes occur when an enzyme clips off the BCNU from the DNA, allowing the cancer cells to live and to replicate. BG (06-benzylguanine) inhibits the enzyme from clipping off the BCNU from the DNA, so the drug can complete its mission and kill the cancer cells. The study team was led by Kevin Cooper, MD, director of the department of dermatology at UHC and chairman and professor of dermatology at CWRU.

The same combination of drugs-BCNU and BG-also was tested in patients with multiple myeloma in a Phase II trial. A malignancy of bone marrow plasma cells, multiple myeloma resembles leukemia, and patients with the disease often relapse after treatment. When malignant plasma cells collect in bone marrow, it causes damage to surrounding bone and suppression of the immune system. Patients who enrolled in the trial had tumors that failed to respond to a standard treatment regimen of chemotherapy. Results are promising: one of the 12 patients treated went into remission and three other patients had a significant shrinkage of tumor lasting many months, a response rate that is similar to the newest FDA-approved drugs. The study team was led by Nizar Bahlis, MD, UHC oncologist and assistant professor of medicine, hematology and oncology at CWRU.

Another Phase I trial involves the first use of Gleevec (also known as STI571) in patients with a variety of solid tumors and renal (kidney) and liver dysfunction. Approved two years ago by the FDA for the treatment of chronic myeloid leukemia, Gleevec was designed to target and destroy abnormal proteins that lead to cancer while leaving non-cancer causing cells relatively undamaged. This trial demonstrated that patients with kidney failure are able to safely receive this powerful cancer treatment. The study team was led by Scot Remick, MD, director of developmental therapeutics at UHC and associate professor of medicine at CWRU.

Phase II trials of Rebeccamycin in treating patients with advanced gall bladder and biliary (bile tract) cancers and lung cancer has shown promising results. Researchers were impressed with survival rates among patients treated, including those who did not appear to be responding to the drug in any clinically measurable way. Among gall bladder and biliary cancer patients studied, 45% experienced therapeutic benefit. The study team was led by Afshin Dawlati, MD, UHC oncologist and assistant professor of hematology and oncology at CWRU.

The Ireland Cancer Center has built an extensive network of community-based cancer centers designed to bring clinical trials and advanced treatments closer to patients’ homes. Ireland Cancer Center services are provided in Canton, Mentor, Middleburg Heights, Orange Village, and Westlake. James K.V. Willson, MD, is director of the Ireland Cancer Center. He leads a staff of nearly 200 researchers, scientists and physicians who are involved in a variety of exciting new approaches to cancer treatment. As an NCI-designated Comprehensive Cancer Center, the Ireland Cancer Center provides physicians, patients and the community with a valuable public service resource, the Ireland Cancer Center Information Service. The service logs nearly 4,000 calls each year, providing advice, referrals and information about ongoing clinical trials, current cancer research and treatment, and cancer prevention, screening and education programs. The phone number is 1-800-641-2422.

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