CAI has entered phase III clinical trial in lung cancer through CTEP. Our phase I study of CAI/paclitaxel has begun a new accrual phase wherein patients receive continuous daily dosing of CAI and have paclitaxel administered three weekly after an initial 8 days of CAI treatment. Patients will receive their CAI at bedtime daily with paclitaxel on a 3 hr infusion q 21 days. Three patients have completed their first cycle with one patient having an exacerbation of pre- existing hyponatremia, felt to be more due to progressive kidney cancer. The pulse CAI/pulse paclitaxel arm is closed to accrual. There have been both partial and minor responses in patients with ovarian/fallopian tube cancer, melanoma, renal cell, and lung cancer. G-CSF has been required in the pulse CAI/pulse paclitaxel arm due to the 14 day interval between paclitaxel administration and the subsequent cycle of drug. This has not been the case in the 3 patients treated to date on the continuous CAI arm. Pharmacokinetics are underway in the continuous arm to confirm the effect of paclitaxel on CAI concentrations. The phase II pharmacokinetically dosed ovarian cancer phase II study has opened and is accruing its initial cohort of 19 patients. Two patients to date have attained the objective of 6 months of disease stabilization. If another patient has a 6 mo stabilization period, the cohort will be expanded. Dosing has been individualized by pharmacokinetic parameters. At least 2 patients did not attain a stable plasma concentration of >/= 2.0 ug/ml and several have required dose modification for plasma concentrations above 5 ug/ml. Accrual is continuing. Collaboration continues with the NEI to investigate local administration of CAI in ocular models. These are directed towards potential administration in a trial of macular degeneration. No direct ocular toxicity has been identified to date in the rabbit models. Studies continue. - metastasis, calcium, angiogenesis, ovarian cancer, - Human Subjects
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