BMTP-11 in Patients With Castrate-Resistant Prostate Cancer With Bone Mets

Prostate Cancer Clinical Trial

Official title: A Limited, First-in-Man, Phase IB Evaluation of BMTP-11 in Patients With Castrate-Resistant Prostate Cancer With High-Volume Osseous Metastases and no Standard Treatment Options

Status Completed

Clinical Trial Summary

The goal of this clinical research study is find the highest tolerable dose of BMTP-11 when given to patients with prostate cancer that has spread. The safety of this drug will also be studied.

Clinical Trial Description

The Study Drug:

BMTP-11 is designed to use a protein to bind to cancer cells, move into the cancer cells, and cause the cancer cells to die. This is the first study using BMTP-11 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 BMTP-11 based on when you joined this study. Up to 2 dose levels of BMTP-11 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 BMTP-11 is found.

Study Drug Administration:

On Days 1, 8, 15, and 22 of each cycle, you will receive BMTP-11 though a needle into your vein over 2 hours.

Before each dose of BMTP-11, you will receive saline (salt water) by vein for over 2 hours.

Study Visits:

On Days 7 and 14 of Cycles 1 and 2, the following tests and procedures will be performed:

• You will have a physical exam, including measurement of your vital signs, height, and weight.

• Your performance status will be recorded.

• You will be asked about any drugs you may be taking and if you have experienced any side effects.

• Blood (about 3 teaspoons) will be collected for routine tests. A portion of this blood will also be used to check your heart health.

• Urine will be collected over 24 hours to test your kidney function.

On Day 21 of Cycles 1 and 2, the following tests and procedures will be performed:

• You will have a physical exam, including measurement of your vital signs, height, and weight.

• Your performance status will be recorded.

• You will be asked about any drugs you may be taking and if you have experienced any side effects.

• Blood (about 3 teaspoons) will be collected for routine tests. A portion of this blood will also be used to check your heart health.

• Blood (about 1 teaspoon) will be drawn to measure your prostatic specific antigen (PSA) and testosterone levels.

• Urine will be collected over 24 hours to test your kidney function.

On Day 1 of Cycle 2, the following tests and procedures will be performed:

• You will have a physical exam, including measurement of your vital signs, height, and weight.

• Your performance status will be recorded.

• You will be asked about any drugs you may be taking and if you have experienced any side effects.

• Blood (about 3 teaspoons) will be collected for routine tests. A portion of this blood will also be used to check your heart health.

• Blood (about 1 teaspoon) will be drawn to measure your PSA and testosterone levels.

Length of Study:

You will be on active study for up to 9 weeks. You will be taken off study if you experience intolerable side effects or the disease gets worse. Please note that even if the treatment has a beneficial effect on the cancer, the treatment cannot be continued for more than two cycles due to the very limited supply of drug available.

End-of-Study Visit:

Between 4 and 6 weeks after the last dose of study drug, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:

• You will have a physical exam, including measurement of your vital signs, height, and weight.

• Your performance status will be recorded.

• You will be asked about any drugs you may be taking and if you have experienced any side effects.

• Blood (about 3-4 teaspoons) and urine will be collected for routine tests. This routine blood draw will include measurement of your PSA and testosterone levels. A part of this blood will also be used to see if your immune system reacted to BMTP-11 by forming an antibody and to assess your heart's health.

• Urine will be collected for 24 hours to test for protein in your urine.

• You will have CT or MRI scans of your abdomen and pelvis to check the status of the disease.

• You will have a chest x-ray.

• You will have a bone scan to check the status of the disease.

Follow-Up:

At 3, 6, and 9 months after the last dose of study drug, you will be called or e-mailed and asked how you are doing. This will only take a few minutes. You will be required to have blood drawn (about 1 teaspoon) for routine testing. This can be done at your local doctor's office and results faxed to MD Anderson Cancer Center (MDACC).

This is an investigational study. BMTP-11 is not FDA approved or commercially available. At this time, BMTP-11 is only being used in research.

Up to 22 patients will take part in this study. All will be enrolled at M. D. Anderson. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00872157
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: March 2009