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Dacarbazine and Carmustine in Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01692691
Recruitment Status : Terminated (PI decision)
First Posted : September 25, 2012
Results First Posted : February 2, 2016
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Western Regional Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma Metastatic
Interventions Drug: Dacarbazine
Drug: Carmustine
Drug: Neulasta
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dacarbazine Carmustine
Hide Arm/Group Description All patients received chemotherapy with Dacarbazine and Carmustine
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Received Treatment
Hide Arm/Group Description Dacarbazine Carmustine participants
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Progression Free Survival
Hide Description Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants 8 Week Survival.
Hide Arm/Group Description:
Number of participants who received Dacarbazine + Carmustine Progression Free survival at 8 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Response Rate
Hide Description To determine the response rate after being treated with Dacarbazine Carmustine
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Response Rate
Hide Arm/Group Description:
Dacarbazine Carmustine
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Median Duration of Response
Hide Description To determine the median duration of response for patients who received Dacarbazine and Carmustine
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dacarbazine Carmustine
Hide Arm/Group Description:
All patients received chemotherapy with Dacarbazine and Carmustine
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Received Treatment
Hide Arm/Group Description Number of Participants who received Dacarbazine Carmustine
All-Cause Mortality
Received Treatment
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Serious Adverse Events
Received Treatment
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Received Treatment
Affected / at Risk (%)
Total   0/1 (0.00%) 
Gastrointestinal disorders   
Nausea   0/1 (0.00%) 
gastroesophageal reflux   0/1 (0.00%) 
General disorders   
Arthalgia   0/1 (0.00%) 
Investigations   
Leukopenia   0/1 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jessica L. Coats
Organization: Western Regional Medical Center
Phone: 623-207-3899
EMail: jessica.coats@ctca-hope.com
Layout table for additonal information
Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01692691    
Other Study ID Numbers: 12-10
First Submitted: August 29, 2012
First Posted: September 25, 2012
Results First Submitted: January 1, 2016
Results First Posted: February 2, 2016
Last Update Posted: April 4, 2018