SuperGen Inc announced that it initiated patient enrollment of a Phase I clinical study of Dacogen (decitabine) for injection, in combination with the Chiron Corporation product Proleukin (aldesleukin) recombinant human interleukin-2 (rh-IL-2), in cancer patients with advanced melanoma and renal cell cancer. Proleukin is indicated for patients with metastatic renal cell carcinoma and metastatic melanoma.

The study was initiated by Jared A. Gollob of the Duke University Medical Center and has an anticipated enrollment of 20 to 40 patients. The primary objective of the study is to determine the toxicity profile and maximum tolerated dose (MTD) of subcutaneous Dacogen followed by intravenous rh-IL-2. Eligibility will include patients with advanced melanoma and renal cell cancer.

Secondary objectives are to access whether Dacogen affects the response rate of rh-IL-2 in melanoma and renal cell cancer, the magnitude and duration of induction of DNA demethylation by Dacogen in the presence of IL-2 and to examine how Dacogen affects immune modulation by rh-IL-2. Pharmacodynamics will also be evaluated. Once the MTD of the combination is established, an additional 10 patients will be treated at the MTD to further assess the antitumor activity of the combination and to obtain additional clinical material for the associated laboratory investigations.

The primary mechanism of action for Dacogen in cancer is thought to be the correction of aberrant DNA methylation, a major mechanism for regulating gene expression and resistance to chemotherapy treatment.

Earlier this year, SuperGen announced that patient enrollment has been completed in an open-label, randomized Phase III clinical study of Dacogen in the treatment of patients with advanced myelodysplastic syndrome (MDS). One hundred seventy patients have been enrolled at 22 clinical sites around the United States, with half receiving Dacogen plus "standard of care" and the other half receiving the current "standard of care" therapy only.