Protocols

SURGICAL PROTOCOLS

1. ID97-328 This protocol is Phase II study of Radiofrequency Ablation of unresectable liver tumors. Radiofrequency Ablation uses an electrocautery device directly in the tumor to eradicate it.

2. ID98-035 This protocol is a Phase II study of Radiofrequency Ablation of colorectal cancer liver metastases combined with post-ablation hepatic arterial infusion of Floxuridine alternating with 5-Fluorouracil. The hypotheses is that the Radiofrequency Ablation treatment will reduce and/or eradicate tumors in the liver, and that post-ablation regional chemotherapy will reduce the incidence of hepatic, and possibly systemic, recurrence of disease.

3. ID99-229

MEDICAL PROTOCOLS

1. DM97-040 This protocol is a Phase II trial of Subcutaneous (SC), Recombinant Human Interferon Alpha (rIFNa 2b), and continuous intravenous (I.V.) 5- Fluorouracil (5FU) for the Treatment of Hepatocellular Carcinoma (HCC). The objective of this protocol is to assess the response rate, response duration, and survival following subcutaneous administration of Recombinant Human Interferon-alpha (rIFNa 2B) AND 5-Fluorouracil (5-FU) by continuous I.V. infusion in patients with HCC. To document toxicity, its severity, and the duration of such toxicity.

2. DM98-337 This protocol is a Phase II trial of (Thalidomide^TM) as an Anti-neoangiogenic Agent in Hepatocellular Carcinoma. The objective of this protocol is to assess the anti-tumor activity of thalidomide in patients with measurable hepatocellular carcinoma (HCC) in-terms of anti-tumor response, response duration, survival; treatment related toxicities and their duration.

3. ID93-024 This protocol is Phase II Trial of a Hepatic Arterial Infusion of Platinol, Recombinant Human Interferon Alpha, Adriamycin, and 5-FI (PIAF) for the Treatment of Hepatocellular Cancer Confined to the Liver. The objective of this protocol is to assess the response rate, response duration, and survival following hepatic arterial infusion of Platinol, Recombinant Human Interferon-alpha, Adriamycin, and 5-Fluorouracil (PIAF) for hepatocellular carcinoma confined to the liver. To determine the qualitative and quantitative toxicity and the reversibility of toxicity of this drug combination.

4. ID99-145 This protocol is a Phase II Study of Intravenous DX-8951f administered daily for five days every three weeks to patients with Hepatocellular Carcinoma. The objective is to assess the anti-tumor activity of DX-8951f when administered as one 30-minute intravenous infusion daily five days every three weeks to patients with measurable hepatocellular carcinoma (HCC) in terms of anti-tumor response, response duration, and survival.

5. ID98-169 This protocol is a Phase II trial of Dolastatin-10 (NSC 376128) administered as an IV bolus every 3 weeks in patients with hepatobiliary cancer. The objective is to determine the response rate, time to progression, and survival of patients with previously untreated advanced hepatobiliary cancer treated with dolastatin-10.

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