In a phase I trial of FR-WBH-TT combined with cisplatin, gemcitabine and interferon-a, 33 patients with very advanced or metastatic cancers of various types were treated with escalating doses of cisplatin. The maximally tolerated dose of cisplatin was found to be 60 mg/m². Although designed to establish toxicity, not response rate, treatment responses were noted. Twenty out of 33 (64%) of patients had either an objective response (20-50% reduction in tumor volume) or a partial response (>50% reduction in tumor volume), though no tumors were completely cured. Many of these patients had failed other treatment regimens.

Response	Number of cases	Percentage (%)
Complete (CR)	0	0
Partial (PR)	14	42
Objective (OR)	6	18
Stable disease (SD)	3	9
Progressive disease (PD)	10	30
Total response (CR+PR+OR)	20/33	64

When the results were broken down by cancer type, it was noted that the response rate appeared particularly promising in:

• pancreatic cancer (4PR, 1SD, 2PD: response rate = 57%)
• gastric cancer (1PR, 1SD: response rate = 50%)
• neuroendocrine tumors (5PR: response rate = 100%)
• esophogeal cancer (1PR, 1SD: response rate = 50%)
• breast cancer (1PR, 1PD: response rate = 50%)
• sarcoma (1PR: response rate = 100%)
• head and neck cancer (1PR: response rate = 100%)

In the pancreatic cancer cases, greatly improved quality of life was observed in 4 of 6 very ill patients, and in one case, survival beyond one year ocurred (average survival is ordinarily less than 4 months from diagnosis).

These initial results led to the design of two phase II clinical trials (which are now ongoing and recruiting patients) of cisplatin, gemcitabine, and interferon-a combined with FR-WB-TT, one restricted to pancreatic cancer, and the other to a broad range of cancers. These trials will investigate treatment response in terms of survival, tumor size reduction, operability, increased quality of life, and immune function.

Preliminary results from the first year of the Phase II pancreas cancer trial were promising:

Response	Number of cases	Percentage (%)
Complete (CR)	1	12.5
Partial (PR)	2	25
Objective (OR)	2	25
Stable disease (SD)	1	12.5
Progressive disease (PD)	2	25
Total response (CR+PR+OR)	5/8	62.5

Toxicities were few and relatively mild (grade 2 leukopenia and grade 2 or 3 thrombocytopenia).

Recent results - 17 patients