Dacarbazine and Carmustine in Metastatic Melanoma

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01692691
First received: August 29, 2012
Last updated: January 1, 2016
Last verified: January 2016
Results First Received: January 1, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma Metastatic
Interventions: Drug: Dacarbazine
Drug: Carmustine
Drug: Neulasta

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Description
Dacarbazine Carmustine All patients received chemotherapy with Dacarbazine and Carmustine

Participant Flow:   Overall Study
    Dacarbazine Carmustine  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  Baseline Characteristics
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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
  Description
Number of Participants Dacarbazine Carmustine

Baseline Measures
    Number of Participants  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures
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1.  Primary:   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 ]

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

3.  Secondary:   Median Duration of Response   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Median Survival of Patients Treated With Combination.   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


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


Results Point of Contact:  
Name/Title: Heather Barilla
Organization: Western Regional Medical Center
phone: 623-207-3649
e-mail: heather.barilla@ctca-hope.com



Responsible Party: Walter Quan Jr., MD, Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01692691     History of Changes
Other Study ID Numbers: 12-10
Study First Received: August 29, 2012
Results First Received: January 1, 2016
Last Updated: January 1, 2016
Health Authority: United States: Institutional Review Board