Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00591370
First received: December 26, 2007
Last updated: October 17, 2015
Last verified: October 2015
Results First Received: January 8, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma
Intervention: Drug: Temozolomide (TMZ)

  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
Protocol Open to Accrual-01/12/2005 Protocol Closed to Accrual-11/27/2007 Primary Completion Date-06/10/2008 Recruitment Location is the medical clinic

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
Temozolomide (TMZ) Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks

Participant Flow:   Overall Study
    Temozolomide (TMZ)  
STARTED     51  
COMPLETED     49  
NOT COMPLETED     2  
Not Treated                 2  



  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
Temozolomide (TMZ) Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks

Baseline Measures
    Temozolomide (TMZ)  
Number of Participants  
[units: participants]
  51  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     23  
>=65 years     27  
Gender  
[units: participants]
 
Female     18  
Male     33  
Region of Enrollment  
[units: participants]
 
United States     51  



  Outcome Measures
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1.  Primary:   Determine the Overall Objective Response Rate (CR and PR).   [ Time Frame: From start of treatment through 24 weeks after ending treatment ]

2.  Secondary:   Overall Survival   [ Time Frame: 18 months after ending treatment ]

3.  Secondary:   Duration of Objective Clinical Responses   [ Time Frame: 24 weeks after ending treatment ]


  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: 212-639-7357
e-mail: chapmanp@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00591370     History of Changes
Other Study ID Numbers: 04-138
Study First Received: December 26, 2007
Results First Received: January 8, 2015
Last Updated: October 17, 2015
Health Authority: United States: Institutional Review Board