OBJECTIVES: I. Investigate the safety and efficacy of SS1(dsFv)-PE38 administered as a
10-day continuous intravenous infusion.
II. Determine the toxicities and maximum tolerated dose (MTD) of SS1(dsFv)-PE38 given by
continuous intravenous infusion for ten days in patients with advanced malignancies.
III. Evaluate response of selected advanced malignancies to continuous intravenous infusion
of SS1(dsFv)-PE38 for ten days at doses near the MTD.
IV. Characterize the plasma kinetics of SS1(dsFv)-PE38 administered by continuous
V. Determine the appearance of serum antibody to SS1(dsFv)-PE38.
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 the
continuous infusion on Day 1 of each treatment course. Each treatment will be given by
continuous intravenous infusion for ten days. After the first 24 hours of infusion, at the
Investigator's discretion, patients will be allowed to leave the hospital on day pass per
NCI policies. After the end of infusion patients will be observed overnight. The first
patient at each dose level must be observed for development of toxicity for at least 14 days
after the beginning of treatment before additional patients are enrolled. At least three
patients will be accrued at each dose level. Dose escalation within a patient will not be
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|