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.
