OBJECTIVES: I. Determine the toxicities and maximum tolerated dose (MTD) of six doses of
SS1(dsFv)-PE38 QOD administered by intravenous infusion to patients with advanced
II. Characterize the plasma pharmacokinetics of SS1(dsFv)-PE38 after intravenous infusion.
III. Determine toxicities attributable to subsequent courses of SS1(dsFv)-PE38.
IV. Evaluate the response of selected advanced malignancies to intravenous infusion of six
doses of SS1(dsFv)-PE38 QOD administered at the MTD.
V. Determine the induction of antibody against SS1(dsFv)-PE38 and its relationship to
PROTOCOL OUTLINE: To exclude immediate allergic hypersensitivity reaction, each patient will
receive a test dose of SS1(dsFv)-PE38, and be observed for 30 minutes prior to receiving
study dosing. Each treatment will be given by intravenous infusion over 30 minutes every
other day. Hydration will be maintained. (Oral hydration may be adequate, but intravenous
hydration may be used at the Investigator?s discretion.) Patients will be observed for at
least 4 hours after infusion on Day 1 of each treatment course to exclude immediate allergic
reaction. Treatment may be repeated for a maximum of two additional courses after 4 weeks
if re-treatment criteria are met. At least three patients will be accrued at each dose
level. Dose escalation within a patient will not be allowed.
PROJECTED ACCRUAL: Up to 30 patients
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
|NCI/NIH||Bethesda, Maryland 20892|