Prohibitin Targeting Peptide 1
Verified April 2014 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: December 16, 2010
Last updated: April 14, 2014
Last verified: April 2014
The goal of this clinical research study is to find the highest tolerable dose of PROHIBITIN-TP01 that can be given to patients with advanced prostate cancer for which there are no standard therapy options. The safety of this drug will also be studied.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Castrate-Resistant Prostate Cancer and No Standard Treatment Options
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||May 2016 (Final data collection date for primary outcome measure)
Prohibitin-TP01 starting dose of 0.03 mg/kg as an injection under the skin 1 time each day for 28 days.
Starting dose of 0.03 mg/kg as an injection under the skin 1 time each day for 28 days.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Have histologically confirmed carcinoma of the prostate, with clinically significant castrate-resistant progression and a BMI defined as obese (i.e. > 30 kg/m^2). Any histologic variant is acceptable aside from pure small cell carcinoma.
- Have progression within the previous 3 months in the face of a serum testosterone of less than 50 ng/dL, and have no standard options for therapy. In general, this means having experienced disease progression (or intolerable side effects) in the context of a second-line hormonal therapy (such as ketoconazole, abiraterone, low-dose dexamethasone, anti-androgens, etc.) in addition to a docetaxel-based therapy, or two cytotoxic therapies, at least one of which included a taxane. Patients are also considered to be eligible if they decline to have additional cytotoxic therapy after failure of a taxane-based regimen. Patients must be at least 3 weeks from their last treatment prior to registration on this study (excluding ongoing therapy to suppress testosterone, which must also be continued during this trial).
- Have an 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 >/= 100,000/mm^3; hemoglobin >/= 8.0 g/dL (without transfusion or growth factor support)
- Have adequate hepatic function defined as a total bilirubin of </= 1.5 mg/dl and AST </= 2x the upper limits of normal
- Have adequate renal function defined as serum creatinine </= 1.5x the upper limit of normal or creatinine clearance >/= 60 mL/min (measured or calculated). In addition, patients must have a 24 hr urine collection showing less than 2000 mg of protein. EXCEPTION: Patients with hematuria will be eligible with up to 3000 mg protein per 24 hours provided they do not have casts, eosinophiluria or electrolyte wasting.
- Have adequate cardiovascular function as defined by: i) a normal B-type Natruetic Peptide (BNP) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal ECG. If these criteria are not met, patients must have an echocardiogram or multigated cardiac scan (MUGA) showing an EF of 45% or greater with no more than "mild" diastolic dysfunction and a BNP of < 200 pg/mL to be eligible.
- 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
- 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: 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, specifically including: i) Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. Note that this may be better established with home BP readings than with clinic visit results. Note further 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. The intent is to exclude patients that may have unrecognized renal damage from chronic, uncontrolled hypertension, NOT to exclude patients who may be hypertensive acutely. There are no absolute criteria for BP readings with respect to eligibility (as determined by treating physician).
- ( # 9 cont'd) (ii) 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 iii) Lung disease requiring supplemental oxygen iv) Known chronic liver disease causing either fibrosis or synthetic dysfunction v) Known HIV infection vi) Overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care.
- Hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. EXCEPTION: Non-obstructive hydronephrosis in setting of prior urinary diversion is consistent with eligibility.
- Patients require ongoing therapy with non-steroidal anti-inflammatory drugs (NSAIDs), i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from NSAIDs from the time the consent is signed up until 30 days after the last dose of study drug is received, other than low-dose aspirin (81 mg/day or less).
- 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
- Age < 18 years.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262664
|Contact: Lance Pagliaro, MD, BA
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Lance Pagliaro, MD, BA
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 16, 2010
||April 14, 2014
||United States: Food and Drug Administration
Keywords provided by M.D. Anderson Cancer Center:
Advanced prostate cancer
Castrate-Resistant Prostate Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 31, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male