Protocol: P03471 – Comparison of PEG-Intron® 1.5 mcg/kg/wk Plus REBETOL® vs. PEG-Intron® 1 mcg/kg/wk Plus REBETOL® vs. PEGASYS® 180 mcg/wk Plus COPEGUS™ in Previously Untreated Adult Subjects with Chronic Hepatitis C Infected with Genotype 1

Principal Investigator: Alexandra L. Gibas, MD

Collaborators: Richard S. Altman, Jr., MD, Carl G. Colton, MD, Daniel C. Connell, MD, Richard J. Elkin, DO, T. Raymond Foley, MD, Ben G. Lazarus, DO, Clifford T. Lomboy, MD, Dale J. Rosenberg, MD, & Dale Whitebloom, DO

Sponsor: Schering-Plough Research Institute

Objective: Schering Plough, the developer of PEG-Intron and REBETOL is comparing its product at two different doses based on subject weight to Hoffman La Roche’s products PEGASYS and COPEGUS in the treatment of Naïve patients with Chronic Hepatitis C. Both products are long acting Interferon once a week injections plus ribavirin, both products are standard care treatment for Chronic Hepatitis C.

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Comparative Evaluation of Cryo-Assisted Localization (CAL) vs. Needle-Wire Localization (NWL) for Breast Lumpectomy

Principal Investigator: Daleela G. Jarowenko, MD

Collaborators: The Lancaster Surgical Group

Sponsor: Sanarus Medical, Inc.

Objective: Breast cancer patients with non-palpable tumors often require re-lumpectomy due to inadequate excision margins. In this project the hope is to decrease or eliminate this problem by creating an iceball around the tumor thus making extent of excision/disease palpable to the surgeon. The cryoablation is currently being used to freeze fibroadenomas in a successful minimally invasive manner. This approach if successful should result in improved cosmesis and a decreased rate of re-operation. In addition cryoablation of small tumors is being used to successfully treat small metastatic lesions of the liver and for primary treatment of small renal carcinomas. This protocol will allow LGH to participate in the forefront of this new technology.