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BMTP-11 in Patients With Castrate-Resistant Prostate Cancer With Bone Mets
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, March 2009
First Received: March 30, 2009   No Changes Posted
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00872157
  Purpose

The Primary Objectives of this study are:

  • To demonstrate localization of BMTP-11 to tumor foci by means of serial bone marrow biopsy.
  • To define likely dose-limiting toxicities and narrow the dose range to be investigated in a subsequent trial that will define the "phase 2 dose."

This will be done by tracking:

  • The clinical toxicity profile, with particular attention to renal tubular toxicity, over the dose range to be investigated in this preliminary trial.
  • Serial PSA and platelet count changes as pharmacodynamic markers that will provide a preliminary sense of the therapeutic index.

Secondary Objectives:

  • Document evidence of clinical activity as shown by improving symptoms, objective regression, or changes in PSA or alkaline phosphatase.
  • Archive serum, urine and bone marrow samples for future studies

Condition Intervention Phase
Prostate Cancer
Drug: BMTP-11
Phase I

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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To study the highest tolerable dose of BMTP-11 when given to patients with prostate cancer that has spread. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

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
1: Experimental
BMTP-11
Drug: BMTP-11
Starting Dose of 18 mg/m^2 by vein over 2 hours on Days 1, 8, 15, and 22.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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. Agree to undergo trans-ilial bone biopsy, and have readily appreciated tumor (i.e. more than a single microscopic focus) demonstrated on a biopsy performed within 6 weeks of registration for protocol intervention. Many patients will have had a bone marrow biopsy as part of clinical care, and this is sufficient for determination of eligibility (i.e. no one will have to repeat the biopsy if it was done for clinical care only).
  3. Have progression in the face of a serum testosterone of less than 50 ng/dL, and have either failed or refused chemotherapy
  4. Have an ECOG performance status 0, 1 or 2
  5. Have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,000/mm3 and platelet count of >/= 140,000/mm3; hemoglobin >/= 9.0 g/dL (without transfusion or growth factor support)
  6. Have adequate hepatic function defined as a total bilirubin of </= 1.5 mg/dl and AST </= 2x the upper limits of normal
  7. Have adequate renal function defined as serum creatinine </= 1.5x the upper limits of normal or creatinine clearance >/= 60 mL/min (measured or calculated). In addition, patients must have either a negative urinalysis for protein (i.e. no more than "trace" by dipstick) or a 24 hr urine collection showing less than 500 mg of protein/24hr.
  8. Have adequate cardiovascular function as defined by: i) a normal beta-naturetic peptide (BNP) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal ECG. Alternatively, patients must have an echocardiogram showing an EF of 45% or greater with no more than "mild" diastolic dysfunction and a BNP of < 200
  9. Sign the current IRB approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution
  10. 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: 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: uncontrolled hypertension (defined as systolic BP

    • 140 and/or diastolic BP >/= 90 despite medication), 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), lung disease requiring supplemental oxygen, known chronic liver disease or HIV infection
  5. 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.)

  6. Overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care
  7. 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
  8. Any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug
  9. Unwillingness to maintain adequate contraception measures for the entire course of the study
  10. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872157

Contacts
Contact: Randall E. Millikan, MD, PHD, BS 713-792-2830

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Randall E. Millikan, MD, PHD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by M.D. Anderson Cancer Center:
Castrate-Resistant Prostate Cancer
Prostate
High-Volume Osseous Metastases
BMTP-11
Prostate State Antigen
PSA

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Neoplasm Metastasis
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

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

ClinicalTrials.gov processed this record on May 07, 2009