Metronomic Therapy in Patients With Metastatic Melanoma

This study has been terminated.
(Low accrual not allowing to support statistical endpoints)
Sponsor:
Information provided by (Responsible Party):
Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01542255
First received: January 17, 2012
Last updated: September 8, 2014
Last verified: September 2014
Results First Received: August 28, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Melanoma
Interventions: Drug: vinblastine
Drug: Cyclophosphamide
Drug: dacarbazine

  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
Enrolled from 6/2010 to 11/2012 at Dartmouth Hitichcock

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Combined Low Dose Treatment

A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.

Schema of treatment is:

1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv

vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.

Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest

dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest


Participant Flow:   Overall Study
    Combined Low Dose Treatment  
STARTED     7  
Analyzed for Time to Progression     7  
COMPLETED     7  
NOT COMPLETED     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.
patients with metastatic melanoma

Reporting Groups
  Description
Combined Low Dose Treatment

A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.

Schema of treatment is:

1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv

vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.

Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest

dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest


Baseline Measures
    Combined Low Dose Treatment  
Number of Participants  
[units: participants]
  7  
Age  
[units: years]
Median ( Full Range )
  65  
  ( 48 to 79 )  
Gender  
[units: participants]
 
Female     1  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures

1.  Primary:   Progression Free Survival   [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]

2.  Secondary:   Clinical Response Rate   [ Time Frame: Tumor evaluation will be performed every 8 weeks from day1 of cycle 1 (+ 1 week) while on therapy, clinical response will be assessed no less than 4 weeks after response criteria met. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
terminated early due to difficulty with scheduling three times per week office treatment


  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: Marc Ernstoff
Organization: Dartmouth-Hitchcock
phone: 603-650-5534
e-mail: marc.s.ernstoff@hitchcock.org


No publications provided


Responsible Party: Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01542255     History of Changes
Other Study ID Numbers: D1010, 22362
Study First Received: January 17, 2012
Results First Received: August 28, 2014
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board