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Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by:
sigma-tau i.f.r. S.p.A.
ClinicalTrials.gov Identifier:
NCT00911443
First received: February 26, 2009
Last updated: July 1, 2009
Last verified: July 2009
Results First Received: February 26, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Malignant Melanoma
Interventions: Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg
Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
Biological: Dacarbazine + Thymosin-alpha-1 3.2 mg
Drug: Dacarbazine + Interferon alpha

  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
Recruitment started on August 2002 and has been completed on January 2006. All patients were recruited at medical clinic facilities (Oncology/Dermatology departments)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only patients who did not meet the entry selection criteria were excluded from study entry.

Reporting Groups
  Description
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazin + Thymosin-alpha-1 3.2 mg Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazin + Interferon Alpha Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.

Participant Flow:   Overall Study
    Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg   Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg   Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg   Dacarbazin + Thymosin-alpha-1 3.2 mg   Dacarbazin + Interferon Alpha
STARTED   97   97   98   99   97 
COMPLETED   97   97   98   99   97 
NOT COMPLETED   0   0   0   0   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.
No text entered.

Reporting Groups
  Description
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazin + Thymosin-alpha-1 3.2 mg Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazin + Interferon Alpha Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Total Total of all reporting groups

Baseline Measures
   Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg   Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg   Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg   Dacarbazin + Thymosin-alpha-1 3.2 mg   Dacarbazin + Interferon Alpha   Total 
Overall Participants Analyzed 
[Units: Participants]
 97   97   98   99   97   488 
Age 
[Units: Participants]
           
<=18 years   0   0   0   0   0   0 
Between 18 and 65 years   69   69   67   73   68   346 
>=65 years   28   28   31   26   29   142 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (14)   54  (14)   56  (13)   56  (11)   57  (12)   55  (13) 
Gender 
[Units: Participants]
           
Female   38   50   45   38   55   226 
Male   59   47   53   61   42   262 
Region of Enrollment 
[Units: Participants]
           
France   14   7   11   6   5   43 
Portugal   0   0   0   0   1   1 
Hungary   3   4   1   2   9   19 
Spain   4   2   2   13   6   27 
Poland   26   28   32   36   37   159 
Germany   17   22   25   10   11   85 
Switzerland   0   0   0   1   0   1 
Italy   33   34   27   31   28   153 


  Outcome Measures
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1.  Primary:   Overall Tumor Response   [ Time Frame: 1 year ]

2.  Secondary:   Overall Survival   [ Time Frame: 2 years ]

3.  Secondary:   Progression Free Survival   [ 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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Roberto Camerini
Organization: R&D Department - Sigma-Tau SpA
phone: +390691393562
e-mail: roberto.camerini@sigma-tau.it



Responsible Party: ROBERTO CAMERINI / Head of Clinical Research II, sigma-tau i.f.r. S.p.A.
ClinicalTrials.gov Identifier: NCT00911443     History of Changes
Other Study ID Numbers: ST1472DM01012
Study First Received: February 26, 2009
Results First Received: February 26, 2009
Last Updated: July 1, 2009
Health Authority: Italy: Ethics Committee
Germany: Ethics Commission
France: Institutional Ethical Committee
Spain: Ethics Committee
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Switzerland: Swissmedic
Portugal: Ethics Committee for Clinical Research