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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 : February 15, 2019
Information provided by (Responsible Party):
Maria Constantinou, Brown University

Tracking Information
First Submitted Date  ICMJE July 24, 2012
First Posted Date  ICMJE July 26, 2012
Results First Submitted Date  ICMJE August 14, 2014
Results First Posted Date  ICMJE July 27, 2015
Last Update Posted Date February 15, 2019
Study Start Date  ICMJE November 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2015)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer. [ Time Frame: 3 months ]
Defined by number of patients who experienced a SAE
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
To assess the toxicity associated with low dose naltrexone for melanoma, CRPC and renal cancer. [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer
Official Title  ICMJE Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer: A Phase II Brown University Oncology Group Research Project
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
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Prostate Cancer
  • Renal Cancer
Intervention  ICMJE Drug: Naltrexone
Study Arms  ICMJE Experimental: Low Dose Naltrexone
LDN, 5 mg/day-(1 cycle = 28 days).
Intervention: Drug: Naltrexone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 11, 2014)
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2012)
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01650350
Other Study ID Numbers  ICMJE BrUOG 275
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maria Constantinou, Brown University
Study Sponsor  ICMJE Maria Constantinou
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Howard Safran, MD Brown University
PRS Account Brown University
Verification Date January 2019

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