Phase II Trial of Extended-Dosing Temozolomide in Patients With 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: NCT00591370
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : January 22, 2015
Last Update Posted : November 18, 2015
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Melanoma
Intervention: Drug: Temozolomide (TMZ)

  Participant Flow

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

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

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

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: 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
First Submitted: December 26, 2007
First Posted: January 11, 2008
Results First Submitted: January 8, 2015
Results First Posted: January 22, 2015
Last Update Posted: November 18, 2015