Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT00872157
Brief 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.
Detailed 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:
NCT00872157
Study Brief:
Protocol Section:
NCT00872157