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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01650350
Recruitment Status : Terminated (Study stopped 10/24/13 secondary to lack of patients/slow enrollment)
First Posted : July 26, 2012
Results First Posted : July 27, 2015
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
Maria Constantinou, Brown University

July 24, 2012
July 26, 2012
August 14, 2014
July 27, 2015
November 17, 2017
November 2012
October 2013   (Final data collection date for primary outcome measure)
Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST [ Time Frame: approximately every 3 months CT, every month physical, up to 6 months ]
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).
determine the response rate of low dose naltrexone for patients with advanced melanoma, castrate refractory prostate cancer (CRPC) or renal cancer [ Time Frame: 3 months ]
Complete list of historical versions of study NCT01650350 on Archive Site
To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer. [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer
Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer: A Phase II Brown University Oncology Group Research Project
will scientifically evaluate whether Low Dose Naltrexone (LDN) has activity in refractory solid tumors within the context of a phase II clinical study

Three types of solid tumors will be studied in this protocol: Melanoma, castrate resistant prostate cancer and kidney cancer. Systemic chemotherapy may weaken the immune system reducing the potential for response to LDN. Therefore, patients must either have not had previous chemotherapy or patients must not have received more than 1 prior chemotherapy regimen which must have been completed at least 6 months prior to LDN. Systemic chemotherapy has at best modest activity in melanoma, CRPC and renal cancer.

  • Melanoma will be evaluated since the responding patient at the Miriam Hospital had melanoma. Immunomodulatory agents such as ipilimumab have already demonstrated a survival advantage in melanoma.
  • Castrate Resistant Prostate Cancer (CRPC): It is common in CRPC for patients to have rising PSA after failure of androgen deprivation. These patients may be asymptomatic or minimally symptomatic and there is reluctance to initiate treatment with systemic chemotherapy with standard docetaxel since this agent has substantial toxicity and will impair quality of life. Waiting until symptomatic disease progression in patients with CRPC and rising PSA is a commonly utilized strategy. These patients are excellent candidates for a treatment with minimal toxicity such as LDA. The immunomodulatory agent Sipuleucel also improves survival in prostate cancer suggesting that an agent such as LDN could also be helpful.
  • Renal cancer will also be studied since this is a disease that has activity with immunomodulants such as IL-2 and interferon. Targeted therapies are generally used for renal cancer. Chemotherapy has minimal activity so most patients are chemotherapy-naive.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Melanoma
  • Prostate Cancer
  • Renal Cancer
Drug: Naltrexone
Experimental: Low Dose Naltrexone
LDN, 5 mg/day-(1 cycle = 28 days).
Intervention: Drug: Naltrexone
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2013
October 2013   (Final data collection date for primary outcome measure)

Conditions for Patient Eligibility

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • 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.
  • Voluntary written informed consent.
  • Conditions for Patient Ineligibility Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
BrUOG 275
Not Provided
Not Provided
Maria Constantinou, Brown University
Maria Constantinou
Not Provided
Study Director: Howard Safran, MD Brown University Oncology Research Group
Brown University
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP