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. Identifier: NCT01692691
Recruitment Status : Terminated (PI decision)
First Posted : September 25, 2012
Results First Posted : February 2, 2016
Last Update Posted : April 4, 2018
Information provided by (Responsible Party):
Western Regional Medical Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Melanoma Metastatic
Interventions: Drug: Dacarbazine
Drug: Carmustine
Drug: Neulasta

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Dacarbazine Carmustine All patients received chemotherapy with Dacarbazine and Carmustine

Participant Flow:   Overall Study
    Dacarbazine Carmustine

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Received Treatment Dacarbazine Carmustine participants

Baseline Measures
   Received Treatment 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      1 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      1 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
United States   1 

  Outcome Measures

1.  Primary:   Progression Free Survival   [ Time Frame: 8 weeks ]

2.  Secondary:   Response Rate   [ Time Frame: 8 weeks ]

3.  Secondary:   Median Duration of Response   [ Time Frame: 8 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Jessica L. Coats
Organization: Western Regional Medical Center
phone: 623-207-3899

Responsible Party: Western Regional Medical Center Identifier: NCT01692691     History of Changes
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