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Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02217709
Recruitment Status : Recruiting
First Posted : August 15, 2014
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Brief Summary:
This phase II trial studies phenelzine sulfate in treating patients with prostate cancer that has not spread to other parts of the body and has come back. Phenelzine sulfate is a type of antidepressant that works by decreasing the amount of a protein called monoamine oxidase (MAO). MAO drugs may have an anticancer effect in prostate cancer.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer Drug: phenelzine sulfate Other: laboratory biomarker analysis Other: questionnaire administration Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the proportion of patients with biochemical recurrent prostate cancer (BCR-PC) treated with phenelzine (phenelzine sulfate) who achieve a prostate-specific antigen (PSA) decline of >= 50% from baseline.

SECONDARY OBJECTIVES:

I. To monitor potential toxicities and/or beneficial effects on quality of life of phenelzine in prostate cancer patients.

II. To assess time to radiographic disease progression for patients with recurrent prostate cancer treated with phenelzine.

III. To collect blood and other samples to study the relationship between MAO activity and prostate cancer.

OUTLINE:

Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade < or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 3 years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Phenelzine in Non-metastatic Recurrent Prostate Cancer
Actual Study Start Date : September 8, 2014
Estimated Primary Completion Date : September 8, 2019
Estimated Study Completion Date : September 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Treatment (phenelzine sulfate)
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade < or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.
Drug: phenelzine sulfate
Given by mouth
Other Name: Nardil

Other: laboratory biomarker analysis
Correlative studies

Other: questionnaire administration
Ancillary studies




Primary Outcome Measures :
  1. Occurrence of PSA decline to >= 50% from baseline following at least 12 weeks of treatment with phenelzine sulfate [ Time Frame: Baseline to up to 12 months ]
    Assessed independently in two groups of patients defined according to circulating androgen levels as: non-castrate and castrate.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Recurrent prostate cancer following primary therapy as defined by:

    • Post-radical prostatectomy: Any PSA >= 0.4 ng/ml
    • Post-primary radiotherapy: PSA >= 2 ng/ml above a post-radiotherapy nadir
    • Post-primary androgen-deprivation therapy: A confirmed rise of PSA >= 2 ng/ml above a post-therapy nadir
  • For patients with non-castrate levels of circulating androgen levels (testosterone >= 50 g/dl)

    • PSA levels should be increasing on at least two occasions >= 1 week apart
    • Patients should not be considered candidates for radiation therapy
  • For patients with castrate levels of circulating androgen levels (testosterone < 50 ng/dl):

    • PSA levels must be >= 0.4 ng/ml (if history of radical prostatectomy) or >= 2 ng/ml (if history of non-surgical primary treatment) and found to be increasing on at least two occasions >= 1 week apart
  • At least 4 weeks must have elapsed since any changes to hormonal therapy, including at least 4 weeks since flutamide and at least 6 weeks since bicalutamide, nilutamide, or enzalutamide
  • No evidence of metastatic cancer on imaging including a bone scan and computed tomography (CT) scan of chest/abdomen/pelvis
  • Able to understand and adhere to dietary and medication restrictions as recommended for the safe use of phenelzine
  • Men with child bearing potential are required to use an effective means of contraception
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) except in cases of benign isolated hyperbilirubinemia such as Gilbert's syndrome.
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SPGT]) =< 2.5 x ULN
  • Creatinine =< 1.5 x ULN

Exclusion Criteria:

  • Uncontrolled hypertension despite appropriate medical therapy (blood pressure [BP] greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the screening visit); Note: patients may be rescreened after adjustment of antihypertensive medications
  • Known prior history of mania or major psychiatric illness (schizophrenia, bipolar disorder, severe major depression requiring hospitalization, etc.)
  • Concurrent use of medications contra-indicated due to potential interactions with phenelzine
  • Inability to comply with dietary restrictions for foods, supplements, and medications with potential for adverse interactions with phenelzine or to otherwise cooperate fully with the investigator and study personnel
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to phenelzine or other monoamine oxidase inhibitors
  • Patients may not be receiving any other investigational agents
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217709


Contacts
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Contact: Olga Castellanos 310-272-7653 ocastell@usc.edu

Locations
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United States, California
USC Norris Westside Cancer Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Olga Castellanos    310-272-7653    ocastell@usc.edu   
Principal Investigator: Mitchell E. Gross         
Los Angeles County-USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Bartolo Santos, RN    323-409-4363    Bartolo.santos@med.usc.edu   
Principal Investigator: Mitchell E. Gross, MD         
Principal Investigator: Jean C. Shih, PhD         
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Charis Barg, RN    323-865-0464    Charis.barg@med.usc.edu   
Principal Investigator: Mitchell E. Gross, MD         
Principal Investigator: Jean C. Shih, PhD         
Keck Medical Center of USC Pasadena Recruiting
Pasadena, California, United States, 91105
Contact: Charis Barg, RN    323-865-0464    Charis.barg@med.usc.edu   
Principal Investigator: Mitchell E. Gross, MD         
Principal Investigator: Jean C. Shih, MD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mitchell Gross, MD University of Southern California
Principal Investigator: Jean C. Shih, PhD University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02217709     History of Changes
Other Study ID Numbers: 4P-14-1
NCI-2014-01791 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HS-14-00331
4P-14-1 ( Other Identifier: USC Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Phenelzine
Antidepressive Agents
Psychotropic Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action