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

NCT00872157 | Completed Phase 1

• 2 other identifiers: 2008-0395NCI-2012-01626
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Castrate-Resistant Prostate Cancer; Prostate; High-Volume Osseous Metastases; BMTP-11; Prostate State Antigen; PSA

Outcome Measures

Primary Outcomes (1)

• Highest tolerable dose of BMTP-11 defined by dose-limiting toxicity

  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)

  Continuous reassessment, review with weekly dose in 4 week cycle.

Study Arms (1)

BMTP-11

EXPERIMENTAL

Starting Dose of 6 mg/m2 by vein over 2 hours on Days 1, 8, 15, and 22.

Drug: BMTP-11

Interventions

BMTP-11 DRUG

Starting Dose of 6 mg/m2 by vein over 2 hours on Days 1, 8, 15, and 22.

BMTP-11

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Have progression in the face of a serum testosterone of less than 50 ng/dL, and have either failed or refused chemotherapy
• Have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• 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.
• Have adequate hepatic function defined as a total bilirubin of \</= 1.5 mg/dl and AST \</= 2\* the upper limits of normal
• 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.
• 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
• 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
• Age \>/= 18 years old

You may not qualify if:

• Small cell prostate cancer
• Infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
• 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)
• 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)
• (# 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
• 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.)
• Overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care
• 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
• Any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug
• Unwillingness to maintain adequate contraception measures for the entire course of the study
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Pasqualini R, Millikan RE, Christianson DR, Cardo-Vila M, Driessen WH, Giordano RJ, Hajitou A, Hoang AG, Wen S, Barnhart KF, Baze WB, Marcott VD, Hawke DH, Do KA, Navone NM, Efstathiou E, Troncoso P, Lobb RR, Logothetis CJ, Arap W. Targeting the interleukin-11 receptor alpha in metastatic prostate cancer: A first-in-man study. Cancer. 2015 Jul 15;121(14):2411-21. doi: 10.1002/cncr.29344. Epub 2015 Apr 1.

  PMID: 25832466 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bone metastasis-targeting peptidomimetic-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Christopher Logothetis, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2015
• Last Updated: October 23, 2015

Record last verified: 2015-10

Locations

US (1)