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

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ClinicalTrials.gov Identifier: NCT00591370
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : January 22, 2015
Last Update Posted : November 18, 2015
Sponsor:
Collaborator:
Schering-Plough
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)
Enrollment 51
Recruitment Details 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  
Arm/Group Title Temozolomide (TMZ)
Hide Arm/Group Description Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Period Title: Overall Study
Started 51
Completed 49
Not Completed 2
Reason Not Completed
Not Treated             2
Arm/Group Title Temozolomide (TMZ)
Hide Arm/Group Description Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
<=18 years
1
   2.0%
Between 18 and 65 years
23
  45.1%
>=65 years
27
  52.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
18
  35.3%
Male
33
  64.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants
51
1.Primary Outcome
Title Determine the Overall Objective Response Rate (CR and PR).
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame From start of treatment through 24 weeks after ending treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Temozolomide (TMZ)
Hide Arm/Group Description:
Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: participants
Complete Response 0
Partial Response 6
Stable Disease 16
Progression of Disease 27
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival at 18 months post treatment
Time Frame 18 months after ending treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Temozolomide (TMZ)
Hide Arm/Group Description:
Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
27
3.Secondary Outcome
Title Duration of Objective Clinical Responses
Hide Description Duration of Response (Objective Clinical Responses)
Time Frame 24 weeks after ending treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Temozolomide (TMZ)
Hide Arm/Group Description:
Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: months
7.7
(4.3 to 11.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Temozolomide (TMZ)
Hide Arm/Group Description Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
All-Cause Mortality
Temozolomide (TMZ)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Temozolomide (TMZ)
Affected / at Risk (%) # Events
Total   7/49 (14.29%)    
Gastrointestinal disorders   
Abdominal pain  1  1/49 (2.04%)  1
Nausea  2  1/49 (2.04%)  1
Infections and infestations   
Skin infection  2  1/49 (2.04%)  1
Investigations   
Lymphocyte count decrease  2  1/49 (2.04%)  1
Metabolism and nutrition disorders   
Anorexia  2  1/49 (2.04%)  1
Musculoskeletal and connective tissue disorders   
Pain in extremity  2  1/49 (2.04%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Treatment-related secondary malignancy  2  1/49 (2.04%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis  2  1/49 (2.04%)  1
Respiratory disorder  2  1/49 (2.04%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC 3.0
2
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Temozolomide (TMZ)
Affected / at Risk (%) # Events
Total   14/49 (28.57%)    
Blood and lymphatic system disorders   
Anemia  1  6/49 (12.24%)  6
Gastrointestinal disorders   
Nausea/Vomiting  1  8/49 (16.33%)  8
General disorders   
Fatigue  1  7/49 (14.29%)  7
Investigations   
Lymphocyte count decrease  1  14/49 (28.57%)  14
WBC/Neutropenia  1  3/49 (6.12%)  3
Hyperbilirubinemia  1  5/49 (10.20%)  5
Metabolism and nutrition disorders   
Anorexia  1  4/49 (8.16%)  4
Hyperglycemia  1  7/49 (14.29%)  7
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain  1  3/49 (6.12%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
ClinicalTrials.gov 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