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

NCT ID: NCT01650350

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-10-31

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.

Conditions

Melanoma; Prostate Cancer; Renal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Dose Naltrexone

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

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Revia and Vivitrol

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard Safran, MD

Role: STUDY_DIRECTOR

Brown University

Locations

Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

BrUOG 275

Identifier Type: -

Identifier Source: org_study_id