Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer

NCT01650350 | Terminated Phase 2 Results DMC

• 1 other identifier: BrUOG 275
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

will scientifically evaluate whether Low Dose Naltrexone (LDN) has activity in refractory solid tumors within the context of a phase II clinical study

Conditions

Melanoma; Prostate Cancer; Renal Cancer

Keywords

Melanoma; Prostate Cancer; Renal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST

  Response will be assessed via RECIST 1.1 criteria utilizing interval CT scans and physical exam after every 3 cycles of treatment (i.e. every 12 weeks).

  approximately every 3 months CT, every month physical, up to 6 months

Secondary Outcomes (1)

• To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer.

  3 months

Study Arms (1)

Low Dose Naltrexone

EXPERIMENTAL

LDN, 5 mg/day-(1 cycle = 28 days).

Drug: Naltrexone

Interventions

Naltrexone DRUG

4.1 Low Dose Naltrexone (LDN) LDN, 5 mg/day, at approximately 9pm, on an empty stomach, until disease progression, unacceptable toxicity, need for initiation of narcotic analgesia, or removal from protocol treatment according to section 12.0. (1 cycle = 28 days). LDN, 5mg/ml, will be prepared by the Lifespan hospital pharmacy for patient use for this study.

Also known as: Revia and Vivitrol

Low Dose Naltrexone

Eligibility Criteria

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

You may qualify if:

• Histologically or pathologically confirmed melanoma, renal cancer or prostate cancer.
• Patients with melanoma or renal cancer must have metastatic disease.
• Patients with melanoma or renal cancer must have radiographically measurable advanced disease. Patients with measurable cutaneous lesions are also evaluable patients with prostate cancer must be castrate refractory and must have radiographically assessable metastatic disease or must have rising PSA on two sequential measurements.
• No prior chemotherapy, or have not received cytotoxic chemotherapy within the 6 months prior to entry..
• No radiation for 3 weeks prior to beginning Naltrexone
• No requirement for opioid analgesics orNo use of opioid analgesics for at least 10 days.
• Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 75,000/uL.
• Total bilirubin ≤ 1.5x upper institutional limit (ULN) and AST or ALT ≤ 3x ULN;
• No prior history of hepatic failure, cirrhosis or hepatic encephalopathy
• ECOG performance status 0 to 2.
• Creatinine \< 1.5 x ULN
• Life expectancy of at least 8 weeks.
• Age ≥ 18 years
• Women of childbearing potential must have a negative pregnancy test.
• Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 1 months thereafter.

You may not qualify if:

• Must not have uncontrolled severe, intercurrent illness.
• Women who are breast-feeding.
• Patients who have undergone major surgery or radiotherapy within the last 3 weeks.
• Patients on concurrent anticancer therapy.
• Patients with known, untreated brain metastasis
• Co-medication that may interfere with study results; e.g opioids
• Known hypersensitivity to any component of naltrexone
• Current or prior alcohol dependence
• Patients who could benefit from conventional therapy are not eligible.

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Miriam Hospital

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Melanoma; Prostatic Neoplasms; Kidney Neoplasms

Interventions

Naltrexone; vivitrol

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Maria Constantinou, MD
• Organization: Brown University Oncology Research Group

Kayla_rosati@brown.edu

401-863-3000

Study Officials

• Howard Safran, MD

  Brown University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: July 24, 2012
• First Posted: July 26, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 4, 2022
• Results First Posted: July 27, 2015

Record last verified: 2022-02

Locations

US (1)