Overview
A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity
Status:
Terminated
Terminated
Trial end date:
2019-01-02
2019-01-02
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
M.D. Anderson Cancer CenterCriteria
Inclusion Criteria:1. Have histologically confirmed carcinoma of the prostate that is metastatic or
otherwise incurable, and a BMI defined as obese (i.e. >30 kg/m2). Any histologic
variant is acceptable other than small cell carcinoma.
2. Have been on androgen deprivation therapy for a minimum of 6 months, and continue that
therapy or an equivalent therapy to suppress testosterone during this trial.
3. Patients with castrate resistant prostate cancer (CRPC) must have no standard options
for therapy. Prior to registration on the study, patients with CRPC must be at least 3
weeks from their last treatment, such as ketoconazole, abiraterone, low-dose
dexamethasone, anti-androgens, or cytotoxic therapy, (excluding ongoing therapy to
suppress testosterone, which must also be continued during this trial).
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/mm^3 and platelet count of >/= 100,000/mm^3; hemoglobin >/= 8.0 g/dL
(without transfusion or growth factor support)
6. Have adequate hepatic function defined as a total bilirubin of
7. Have adequate renal function defined as serum creatinine 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.
8. 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.
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
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,
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).
5. ( # 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.
6. 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.
7. 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).
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. Age < 18 years.