Trial Outcomes & Findings for Metronomic Therapy in Patients With Metastatic Melanoma (NCT NCT01542255)
NCT ID: NCT01542255
Last Updated: 2019-01-15
Results Overview
Tumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy assessed by RECIST 1.0 criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results posted on
2019-01-15
Participant Flow
Enrolled from 6/2010 to 11/2012 at Dartmouth Hitichcock
Participant milestones
| Measure |
Combined Low Dose Treatment
A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.
Schema of treatment is:
1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv
vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.
Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest
dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
Analyzed for Time to Progression
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metronomic Therapy in Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Combined Low Dose Treatment
n=7 Participants
A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.
Schema of treatment is:
1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv
vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.
Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest
dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest
|
|---|---|
|
Age, Continuous
|
65 years
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: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsTumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy assessed by RECIST 1.0 criteria.
Outcome measures
| Measure |
Single Arm
n=7 Participants
|
|---|---|
|
Progression Free Survival
|
3 weeks
Interval 3.0 to 15.0
|
SECONDARY outcome
Timeframe: Tumor evaluation will be performed every 8 weeks from day1 of cycle 1 (+ 1 week) while on therapy, clinical response will be assessed no less than 4 weeks after response criteria met.To be assigned a status of partial response or complete response, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of stable disease, follow-up measurements must have met the stable disease criteria at least once after study entry at a minimum interval (in general, not less than 6-8 weeks) that is defined in the study protocol
Outcome measures
| Measure |
Single Arm
n=7 Participants
|
|---|---|
|
Clinical Response Rate
Stable Disease
|
2 Participants
|
|
Clinical Response Rate
Progressive Disease
|
5 Participants
|
Adverse Events
Single Arm
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm
n=7 participants at risk
all patients received cyclophosphamide, DTIC and vinblastine
|
|---|---|
|
Investigations
alanine aminotransferase increased
|
14.3%
1/7 • Number of events 4 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Skin and subcutaneous tissue disorders
alopecia
|
42.9%
3/7 • Number of events 3 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Eye disorders
Blurred vision
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Gastrointestinal disorders
constipation
|
28.6%
2/7 • Number of events 2 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Investigations
Creatinine increased
|
42.9%
3/7 • Number of events 3 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Gastrointestinal disorders
diarrhea
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
General disorders
Edema - limbs
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 2 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
2/7 • Number of events 2 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Nervous system disorders
Memory impairment
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Psychiatric disorders
Mental status changes
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
28.6%
2/7 • Number of events 2 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain - extremity
|
28.6%
2/7 • Number of events 2 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Cardiac disorders
Palpitations
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Investigations
Platelet count decreased
|
28.6%
2/7 • Number of events 7 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Gastrointestinal disorders
Toothache
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Nervous system disorders
Tremor
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for each subject from the time of start of treatment until 30 days after the last dose of treatment. As this study ended prematurely, adverse events were collected only for the seven subjects enrolled over a period of 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place