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

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ClinicalTrials.gov Identifier: NCT00872157
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : October 23, 2015
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: BMTP-11 Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2009
Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BMTP-11
Starting Dose of 6 mg/m2 by vein over 2 hours on Days 1, 8, 15, and 22.
Drug: BMTP-11
Starting Dose of 6 mg/m2 by vein over 2 hours on Days 1, 8, 15, and 22.

Primary Outcome Measures :
  1. Highest tolerable dose of BMTP-11 defined by dose-limiting toxicity [ Time Frame: Continuous reassessment, review with weekly dose in 4 week cycle. ]

    Dose-limiting toxicities defined if they are considered to be possibly, probably or definitely related to study drug:

    • Any grade 3/4 non-hematologic Adverse Event

    • Rise in serum creatinine such that the predicted clearance falls by >40% from baseline

    • Febrile neutropenia

    • Platelet transfusion (either given, or indicated by American Society of Clinical Oncology (ASCO) consensus criteria of 10,000 platelets per microliter)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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
  2. Have progression in the face of a serum testosterone of less than 50 ng/dL, and have either failed or refused chemotherapy
  3. Have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  4. Have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,000/mm^3 and platelet count of >/= 140,000/mm^3; hemoglobin >/= 9.0 g/dL (without transfusion or growth factor support), unless the patient is < 6 weeks from last cancer therapy in which case transfusion is allowed.
  5. Have adequate hepatic function defined as a total bilirubin of </= 1.5 mg/dl and AST </= 2* the upper limits of normal
  6. Have adequate renal function defined as serum creatinine </= 1.5* the upper limits of normal or creatinine clearance >/= 60 mL/min (measured or calculated). In the absence of hematuria, patients must have either a negative urinalysis for protein (i.e. no more than "trace" by dipstick) or a 24 hour urine collection showing less than 1,000 mg of protein/24 hour. In the presence of hematuria, patients may have up to 2,000 mg of protein/24 hour.
  7. Have adequate cardiovascular function as defined by: i) a normal beta-natruetic peptide (BNP) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal Electrocardiography (ECG). Alternatively, patient not meeting all of these criteria is still eligible if he has both i) an echocardiogram showing an ejection fraction (EF) of 45% or greater (and no more than "mild" diastolic dysfunction) and ii) a Brain Natriuretic Peptide (BNP)of < 200
  8. Sign the current Institutional Review Board (IRB) approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution
  9. Age >/= 18 years old

Exclusion Criteria:

  1. Small cell prostate cancer
  2. Infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
  3. Any of the following in previous 6 months: New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ECG or serologic criteria)
  4. Significant co-morbidity that could affect the safety or evaluability of participants, including: a) Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. Note that this is NOT a criterion related to particular BP results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. (Please see further explanation in the Treatment Plan below)
  5. (# 4 cont'd) b) uncontrolled diabetes mellitus (defined as Hgb A1c > 8.5, or symptomatic hypoglycemic episodes > 1 per week during the two months prior to eligibility evaluation, or more than 1 glucose excursion to >300 mg/dL in prior two months--unless clearly iatrogenic and the cause has been eliminated),c) lung disease requiring supplemental oxygen, d) known chronic liver disease, or e) HIV infection
  6. 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.)
  7. Overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care
  8. Patients must not require ongoing therapy with non-steroidal anti-inflammatories (NSAIDs),other than low-dose (i.e. 81 mg or less) aspirin daily, i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from NSAIDs for the duration of their participation in the trial
  9. Any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug
  10. Unwillingness to maintain adequate contraception measures for the entire course of the study
  11. Any therapy for prostate cancer (other than ongoing androgen deprivation or associated hormonal therapies such as diethylstilbesterol, low-dose dexamethasone, megace, etc) in the two weeks prior to starting BMTP-11

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872157

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Christopher Logothetis, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00872157     History of Changes
Other Study ID Numbers: 2008-0395
NCI-2012-01626 ( Registry Identifier: NCI CTRP )
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: October 2015

Keywords provided by M.D. Anderson Cancer Center:
Castrate-Resistant Prostate Cancer
High-Volume Osseous Metastases
Prostate State Antigen

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases