Trial Outcomes & Findings for Dacarbazine and Carmustine in Metastatic Melanoma (NCT NCT01692691)

Results Overview

Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

8 weeks

Results posted on

2018-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Dacarbazine Carmustine All patients received chemotherapy with Dacarbazine and Carmustine
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dacarbazine and Carmustine in Metastatic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Received Treatment n=1 Participants Dacarbazine Carmustine participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained.

Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained.

To determine the response rate after being treated with Dacarbazine Carmustine

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained.

To determine the median duration of response for patients who received Dacarbazine and Carmustine

Outcome measures

Outcome data not reported

Adverse Events

Received Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Received Treatment n=1 participants at risk Number of Participants who received Dacarbazine Carmustine
Gastrointestinal disorders Nausea	0.00% 0/1
General disorders Arthalgia	0.00% 0/1
Gastrointestinal disorders gastroesophageal reflux	0.00% 0/1
Investigations Leukopenia	0.00% 0/1

Additional Information

Jessica L. Coats

Western Regional Medical Center

Phone: 623-207-3899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place