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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00872157 |
The Primary Objectives of this study are:
This will be done by tracking:
Secondary Objectives:
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: BMTP-11 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 14 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
BMTP-11
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Drug: BMTP-11
Starting Dose of 18 mg/m^2 by vein over 2 hours on Days 1, 8, 15, and 22.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have histologically confirmed adenocarcinoma of the prostate, with clinically significant bone metastases exhibiting castrate-resistant progression.
Progression is defined as any of the following: 1) New lesions or obviously worsening lesions on bone scan within the previous three months; 2) a PSA doubling time of < 3 months; 3) New or progressive symptoms requiring a change in therapy that are referable to the cancer; 4) New extra-osseous lesions within the past 3 months
Exclusion Criteria:
Significant co-morbidity that could affect the safety or evaluability of participants, including: uncontrolled hypertension (defined as systolic BP
Hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent.
(Non-obstructive hydronephrosis in setting of prior urinary diversion is allowed.)
Contact: Randall E. Millikan, MD, PHD, BS | 713-792-2830 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 |
Principal Investigator: | Randall E. Millikan, MD, PHD, BS | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Randall E. Millikan,MD, PHD, BS ) |
Study ID Numbers: | 2008-0395 |
Study First Received: | March 30, 2009 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00872157 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Castrate-Resistant Prostate Cancer Prostate High-Volume Osseous Metastases |
BMTP-11 Prostate State Antigen PSA |
Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |