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

Primary Purpose

Melanoma, Prostate Cancer, Renal Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Naltrexone

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Prostate Cancer, Renal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Miriam Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low Dose Naltrexone

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST

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

To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer.

Defined by number of patients who experienced a SAE

Full Information

NCT ID

NCT01650350

First Posted

July 24, 2012

Last Updated

February 23, 2022

Sponsor

Brown University

1. Study Identification

Unique Protocol Identification Number

NCT01650350

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

Study stopped 10/24/13 secondary to lack of patients/slow enrollment

Study Start Date

November 2012 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brown University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma, Prostate Cancer, Renal Cancer

Keywords

Melanoma, Prostate Cancer, Renal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Dose Naltrexone

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Naltrexone

Other Intervention Name(s)

Revia and Vivitrol

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.

Primary Outcome Measure Information:

Title

Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST

Description

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).

Time Frame

approximately every 3 months CT, every month physical, up to 6 months

Secondary Outcome Measure Information:

Title

To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer.

Description

Defined by number of patients who experienced a SAE

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Howard Safran, MD

Organizational Affiliation

Brown University

Official's Role

Study Director

Facility Information:

Facility Name

Miriam Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02912

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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