Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer
NCT ID: NCT02217709
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2014-09-08
2020-06-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
phenelzine sulfate
Given by mouth
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
Interventions
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phenelzine sulfate
Given by mouth
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Mitchell Gross, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Jean C. Shih, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Norris Westside Cancer Center
Beverly Hills, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Keck Medical Center of USC Pasadena
Pasadena, California, United States
Countries
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Other Identifiers
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NCI-2014-01791
Identifier Type: REGISTRY
Identifier Source: secondary_id
HS-14-00331
Identifier Type: -
Identifier Source: secondary_id
4P-14-1
Identifier Type: OTHER
Identifier Source: secondary_id
4P-14-1
Identifier Type: -
Identifier Source: org_study_id