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
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 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 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Highest tolerable dose of BMTP-11 defined by dose-limiting toxicity
Continuous reassessment, review with weekly dose in 4 week cycle.
Yes
Christopher Logothetis, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2008-0395
NCT00872157
March 2009
Name | Location |
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UT MD Anderson Cancer Center | Houston, Texas 77030 |