Safety Study of a Cell Penetrating Peptide (p28) to Treat Solid Tumors That Resist Standard Methods of Treatment
The purpose of this study is to evaluate the safety of an experimental drug (p28) as a treatment for certain advanced cancers which express a protein called p53 and which have not responded to prior treatment.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of p28 (Cell Penetrating Peptide) in the Treatment of Refractory Solid Tumors|
- Clinical and laboratory adverse reactions will be closely monitored by periodic physical and laboratory examination. [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]
- Grade 3 non-hematologic or Grade 4 hematologic toxicity will also define the Maximum Feasible Dose (MFD). [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]
- Reduction in the size of measurable tumors using the RECIST criteria and, if possible, demonstration of p28 localization and biopsy of tumor. [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
- Calculate peak (serum) concentration of p28 and compare with any sign of toxicity and response. [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: p28 Phase I Safety
A total of 15 patients were administered p28 i.v. as a short infusion three times per week for 4 weeks followed by a 2-week rest under an accelerated titration 3þ3 dose escalation design.
p28 will be dissolved in normal saline and infused intravenously into the patient over 15-30 minutes.
Other Name: azurin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914914
|United States, Illinois|
|University of Illinois at Chicago Department of Surgical Oncology|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Michael A Warso, M.D.||University of Illinois Department of Surgical Oncology|