MIAMI BEACH—Heat shock protein peptide complex-96 (HSPPC-96, Oncophage), an individualized cancer vaccine, produced complete responses in two patients with metastatic melanoma and long-term stable disease in several others during an Italian phase I-II trial.

Giorgio Parmiani, MD, of the Istituto Nazionale per lo Studio e la Cura dei Tumori in Milan, sent results on 39 patients (abstract 799) for presentation at Molecular Targets and Cancer Therapeutics, an international conference cosponsored by the American Association for Cancer Research (AACR), National Cancer Institute (NCI), and European Organization for Research and Treatment of Cancer (EORTC).

None of the patients had any toxic reactions to the vaccine—not even skin irritation, Dr. Parmiani told the press by telephone from Italy. He is the deputy scientific director and head of the immunotherapy unit at the Institute.

There were two complete responders among 28 patients who had measurable disease after surgery to excise their tumors (see Figure). They have been followed for 559+ and 703+ days, respectively. Three others have maintained stable disease for more than 5 months.

Among 11 patients who had no measurable disease after surgery, two have been disease-free for more than 1 year, Dr. Parmiani said.

"Overall survival appears to be unusual in this group of patients," he said, noting that median survival is usually about 6 months for patients with stage IV melanoma.

HSPPC-96 uses heat-shock proteins derived from the tumors of each individual patient to make a unique vaccine for each patient. "It is important that the protein comes from the patient’s own tumor because each tumor is different as far as this antigen is concerned," Dr. Parmiani said.