A Phase I Trial of p28 (Cell Penetrating Peptide) in the Treatment of Refractory Solid Tumors
The drug used in this study is p28, a cancer cell killing peptide. A peptide is a compound
made of amino acids, which are substances that the body uses to make protein. The p28
peptide was created from a protein called azurin. Azurin is created by a common
disease-causing bacteria named Pseudomonas Aeruginosa. p28 is experimental and has not yet
been tested in humans and has not been approved by the FDA for use in cancer subjects.
Up to 30 subjects may be enrolled in order to find 15 subjects who qualify for the study.
Subjects will be enrolled in groups of three, each starting at one of five progressively
higher dosage groups. The first group of three subjects will receive the lowest dose of p28
three times a week injected into a vein for four weeks. They will then be monitored for two
weeks. If no bad side effects are recorded, the initial three subjects will then receive
the second (higher) dose level of p28 three times a week for another four weeks, followed,
again, by two weeks of follow up. Additionally, three new subjects will be added to the
study and receive p28 on the same schedule, although this second group will start with the
second dose level. In this manner, 3 new subjects will be added every six weeks and start
treatment at the dose level to which previously enrolled groups have now progressed.
Subjects will be monitored weekly during their first six weeks and then every two weeks for
the remainder of the study. Monitoring will include physical exams, blood tests, EKG, and
appropriate radiographic imaging (CT, MRI, PET scan, and/or chest X-ray).
The entire study should take 32 weeks for subjects starting at dose 1, 26 weeks for subjects
starting at dose 2, 20 weeks for subjects starting at dose 3, 14 weeks for subjects starting
at dose 4, and 8 weeks for subjects starting at dose 5 (there is an additional 2 week
follow-up period at the end of the study for all subjects included in these figures). All
surviving subjects however, will be followed according to the normal follow-up schedule for
such subjects at the UIC Oncology Center.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical and laboratory adverse reactions will be closely monitored by periodic physical and laboratory examination.
Michael A Warso, M.D.
University of Illinois Department of Surgical Oncology
United States: Food and Drug Administration
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