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Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00885534
First received: April 21, 2009
Last updated: April 21, 2015
Last verified: April 2015
Results First Received: April 7, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Melanoma
Skin Cancer
Intervention: Drug: Cisplatin, Vinblastine, Temozolomide

  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
Cisplatin, Vinblastine, Temozolomide

Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:

Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1.


Participant Flow:   Overall Study
    Cisplatin, Vinblastine, Temozolomide  
STARTED     7  
COMPLETED     6  
NOT COMPLETED     1  
Patient deemed ineligible                 1  



  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.
No text entered.

Reporting Groups
  Description
Cisplatin, Vinblastine, Temozolomide

Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:

Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1.


Baseline Measures
    Cisplatin, Vinblastine, Temozolomide  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     4  
Gender  
[units: participants]
 
Female     1  
Male     6  



  Outcome Measures

1.  Primary:   Overall Response to CVT Chemotherapy.   [ Time Frame: 2 years ]


  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: Dr. Paul Chapman
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4162
e-mail: chapmanp@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00885534     History of Changes
Other Study ID Numbers: 09-017
Study First Received: April 21, 2009
Results First Received: April 7, 2015
Last Updated: April 21, 2015
Health Authority: United States: Institutional Review Board