A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity

Prostate Cancer Clinical Trial

Official title: A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity

Status Terminated

Clinical Trial Summary

The goal of this clinical research study is to find the highest tolerable dose of PROHIBITIN-TP01 that can be given to patients with advanced prostate cancer for which there are no standard therapy options. The safety of this drug will also be studied.

Clinical Trial Description

The Study Drug:

PROHIBITIN-TP01 is designed to destroy "white fat" (the type of fat that collects around the stomach and is associated with obesity in men). Fat is known to produce substances that can promote prostate cancer growth. Investigators want to learn if decreasing fat can slow the growth of prostate cancer.

This is the first study using PROHIBITIN-TP01 in humans.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of PROHIBITIN-TP01 based on when you join this study. Up to 5 dose levels of PROHIBITIN-TP01 will be tested. Three (3) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of PROHIBITIN-TP01 is found.

Study Drug Administration:

You will receive PROHIBITIN-TP01 as an injection under the skin 1 time each day for 28 days.

Study Visits:

On Days 1, 8, 15 and 22:

• You will have a physical exam, including measurement of your weight.

• Your performance status will be recorded.

• Blood (about 3 teaspoons) will be drawn for routine tests. You will be required to fast for about 8 hours before this blood test.

• You will be asked about any symptoms or side effects you may have had since your last visit and about any other drugs you may be taking.

• Blood (about 2 teaspoons) will be drawn for PK testing 10 minutes, 30 minutes, 1 hour, and 4 hours after you receive the Day 1 and Day 22 dose of PROHIBITIN-TP01.

• You will have an ECG either right before or within 4 hours after you receive the study drug (Days 1, 15, and 22 only).

Length of Study Drug Administration:

You will receive the study drug for up to 28 days. You will no longer be able to receive the study drug if the disease gets worse or intolerable side effects occur.

Follow-up Visit:

Within 7 days after you stop receiving the study drug, the following procedures will be performed:

• You will have a physical exam, including measurement of your weight, as well as measurements of your waist and hips.

• Your performance status will be recorded.

• Blood (about 3 teaspoons) will be drawn for routine tests. This testing will also include a measurement of your PSA, testosterone, cholesterol, and other research tests that may show how the study drug affected you.

• You will be asked about symptoms or any side effects you have had since your last visit.

• You will have CT or MRI scans and a chest x-ray to check the status of the disease.

• You will have an ECG

Thirty (30) days after you stop receiving the study drug, the following procedures will be performed:

• You will have a physical exam, including measurement of your weight.

• Your performance status will be recorded.

• Blood (about 3 teaspoons) will be drawn for routine tests.

• Blood (about 3 teaspoons - in addition to that listed above) will be collected to learn if your immune system reacts to PROHIBITIN-TP01 by forming antibodies.

• You will be asked about symptoms or any side effects you have had since your last visit.

• You will have an ECG

Long-Term Follow-Up:

You will be contacted by phone or e-mail every 3 months for 1 year and asked about your kidney function, current weight, prostate cancer status, and any side effects you may have had. Each phone call will last up to 5 minutes.

This is an investigational study. PROHIBITIN-TP01 is not FDA approved or commercially available. It is currently being used for research purposes only.

Up to 39 patients will take part in this study. All will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01262664
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 1
• Start date: May 24, 2012
• Completion date: January 2, 2019