Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Northwestern Memorial Hospital
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00026494
First received: November 9, 2001
Last updated: December 15, 2015
Last verified: December 2015
Results First Received: December 15, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Cancer
Interventions: Drug: temozolomide
Drug: vinorelbine tartrate

  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
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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
15mg/m2 - Vinorelbine Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
20mg/m2 - Vinorelbine Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
25mg/m2 - Vinorelbine Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
30mg/m2 - Vinorelbine Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases

Participant Flow:   Overall Study
    15mg/m2 - Vinorelbine     20mg/m2 - Vinorelbine     25mg/m2 - Vinorelbine     30mg/m2 - Vinorelbine  
STARTED     7     4     22     16  
COMPLETED     5     4     16     16  
NOT COMPLETED     2     0     6     0  
Withdrawal by Subject                 1                 0                 1                 0  
Patient non-compliance                 1                 0                 0                 0  
Patient not treated                 0                 0                 2                 0  
Clinical progression                 0                 0                 3                 0  



  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
15mg/m2 - Vinorelbine Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
20mg/m2 - Vinorelbine Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
25mg/m2 - Vinorelbine Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
30mg/m2 - Vinorelbine Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
Total Total of all reporting groups

Baseline Measures
    15mg/m2 - Vinorelbine     20mg/m2 - Vinorelbine     25mg/m2 - Vinorelbine     30mg/m2 - Vinorelbine     Total  
Number of Participants  
[units: participants]
  7     4     22     16     49  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     5     2     17     10     34  
>=65 years     2     2     5     6     15  
Gender  
[units: participants]
         
Female     5     1     13     10     29  
Male     2     3     9     6     20  



  Outcome Measures

1.  Primary:   Radiographic Response Assessed by Macdonald Criteria Every 2 Months   [ 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. Lisa Deangelis
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-7997
e-mail: deangell@mskcc.org


Publications of Results:

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00026494     History of Changes
Other Study ID Numbers: 01-088
MSKCC-01088A
NCI-G01-2025
Study First Received: November 9, 2001
Results First Received: December 15, 2015
Last Updated: December 15, 2015
Health Authority: United States: Institutional Review Board