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

NCT02217709 | Completed Phase 2 DMC FDA Drug

• 4 other identifiers: 4P-14-1NCI-2014-01791HS-14-00331P30CA014089
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

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.

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Occurrence of PSA decline to >= 50% from baseline following at least 12 weeks of treatment with phenelzine sulfate

  Assessed independently in two groups of patients defined according to circulating androgen levels as: non-castrate and castrate.

  Baseline to up to 12 months

Study Arms (1)

Treatment (phenelzine sulfate)

EXPERIMENTAL

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; Other: laboratory biomarker analysis; Other: questionnaire administration

Interventions

phenelzine sulfate DRUG

Given by mouth

Also known as: Nardil

Treatment (phenelzine sulfate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (phenelzine sulfate)

questionnaire administration OTHER

Ancillary studies

Treatment (phenelzine sulfate)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

USC Norris Westside Cancer Center

Beverly Hills, California, 90211, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Keck Medical Center of USC Pasadena

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Phenelzine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals

Study Officials

• Mitchell Gross, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Jean C. Shih, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 15, 2014
• Study Start: September 8, 2014
• Primary Completion: June 29, 2020
• Study Completion: June 29, 2020
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

US (4)