Trial Outcomes & Findings for Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer (NCT NCT01650350)
NCT ID: NCT01650350
Last Updated: 2022-03-04
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
approximately every 3 months CT, every month physical, up to 6 months
Results posted on
2022-03-04
Participant Flow
Participant milestones
| Measure |
Low Dose Naltrexone
LDN, 5 mg/day-(1 cycle = 28 days).
Naltrexone
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer
Baseline characteristics by cohort
| Measure |
Low Dose Naltrexone
n=7 Participants
LDN, 5 mg/day-(1 cycle = 28 days).
Naltrexone
|
|---|---|
|
Age, Continuous
|
79.4 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately every 3 months CT, every month physical, up to 6 monthsResponse 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).
Outcome measures
| Measure |
Melanoma: Low Dose Naltrexone
n=1 Participants
LDN, 5 mg/day-(1 cycle = 28 days).
Naltrexone
|
Prostate Cancer- Low Dose Naltrexone
n=6 Participants
LDN, 5 mg/day-(1 cycle = 28 days).
Naltrexone
|
|---|---|---|
|
Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST
stable disease by RECIST
|
0 participants
|
2 participants
|
|
Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST
progression of disease by PSA
|
0 participants
|
6 participants
|
|
Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST
progression via RECIST
|
0 participants
|
1 participants
|
|
Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST
progression clinical
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3 monthsDefined by number of patients who experienced a SAE
Outcome measures
| Measure |
Melanoma: Low Dose Naltrexone
n=7 Participants
LDN, 5 mg/day-(1 cycle = 28 days).
Naltrexone
|
Prostate Cancer- Low Dose Naltrexone
LDN, 5 mg/day-(1 cycle = 28 days).
Naltrexone
|
|---|---|---|
|
To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer.
|
0 Participants
|
—
|
Adverse Events
Low Dose Naltrexone
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose Naltrexone
n=7 participants at risk
LDN, 5 mg/day-(1 cycle = 28 days).
Naltrexone
|
|---|---|
|
Investigations
Anemia
|
57.1%
4/7 • Number of events 4 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
RBC
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
infection
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
abd pain
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
kidney pain
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
fatigue
|
42.9%
3/7 • Number of events 3 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
anorexia
|
28.6%
2/7 • Number of events 2 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
nausea
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
upset stomach
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
diarrhea
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
leg cyst
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
LFT
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
seg neutrophils
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
constipation
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
dyspnea
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
achilles pain
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
pain scalp
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
scalp lesion- Moh's
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
weight loss
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
PLT
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
Rash- thigh
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
creatinine
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
edema
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
Pain- shoulder
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
pain-hip
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
|
Investigations
insomnia
|
14.3%
1/7 • Number of events 1 • Monthly and 30 days post last dose of drug (approximately 9 months)
|
Additional Information
Maria Constantinou, MD
Brown University Oncology Research Group
Phone: 401-863-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place