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

This study has been completed.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center Identifier:
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
Temozolomide (TMZ) Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks

Participant Flow:   Overall Study
    Temozolomide (TMZ)
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
Temozolomide (TMZ) Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks

Baseline Measures
   Temozolomide (TMZ) 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   1 
Between 18 and 65 years   23 
>=65 years   27 
[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

Responsible Party: Memorial Sloan Kettering Cancer Center 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