Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer
Condition: Melanoma; Prostate Cancer; Renal Cancer
MeSH terms: Prostatic Neoplasms; Melanoma; Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: Naltrexone
Intervention description: 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.
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma; Prostate Cancer; Renal Cancer

Summary:

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

Eligibility criteria:

        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.