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

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ClinicalTrials.gov 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 : March 4, 2022
Information provided by (Responsible Party):
Brown University

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

Condition or disease Intervention/treatment Phase
Melanoma Prostate Cancer Renal Cancer Drug: Naltrexone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer: A Phase II Brown University Oncology Group Research Project
Study Start Date : November 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: Low Dose Naltrexone
LDN, 5 mg/day-(1 cycle = 28 days).
Drug: Naltrexone

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.

Other Name: Revia and Vivitrol

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650350

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United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
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Study Director: Howard Safran, MD Brown University
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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT01650350    
Other Study ID Numbers: BrUOG 275
First Posted: July 26, 2012    Key Record Dates
Results First Posted: July 27, 2015
Last Update Posted: March 4, 2022
Last Verified: February 2022
Keywords provided by Brown University:
Prostate Cancer
Renal Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents