Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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.


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
6. Have adequate renal function defined as serum creatinine 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 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Christopher Logothetis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2008-0395

NCT ID:

NCT00872157

Start Date:

March 2009

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Castrate-Resistant Prostate Cancer
  • Prostate
  • High-Volume Osseous Metastases
  • BMTP-11
  • Prostate State Antigen
  • PSA
  • Prostatic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030