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Sargramostim and/or Vaccine Therapy in Preventing Disease Recurrence in Patients With Advanced Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01989572
First received: November 18, 2013
Last updated: July 22, 2014
Last verified: March 2014
Results First Received: July 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Local Recurrence of Malignant Melanoma of Skin
Stage IV Melanoma
Interventions: Biological: sargramostim
Biological: peptide vaccine
Other: GM-CSF placebo
Other: peptide placebo

  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
The study was open between December 29, 1999 and October 31, 2006. A total of 815 patients were enrolled.

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
Arm I (GM-CSF, Peptide Vaccine)

Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC

peptide vaccine: Given SC

Arm II (GM-CSF Placebo, Peptide Vaccine)

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

peptide vaccine: Given SC

GM-CSF placebo: Given SC

Arm III (GM-CSF, Peptide Placebo)

Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC

peptide placebo: Given SC

Arm IV (GM-CSF Placebo, Peptide Placebo)

Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

GM-CSF placebo: Given SC

peptide placebo: Given SC

Arm V (GM-CSF)

Patients receive GM-CSF (sargramostim) SC on days 1-14.

sargramostim: Given SC

Arm VI (GM-CSF Placebo)

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.

GM-CSF placebo: Given SC


Participant Flow:   Overall Study
    Arm I (GM-CSF, Peptide Vaccine)     Arm II (GM-CSF Placebo, Peptide Vaccine)     Arm III (GM-CSF, Peptide Placebo)     Arm IV (GM-CSF Placebo, Peptide Placebo)     Arm V (GM-CSF)     Arm VI (GM-CSF Placebo)  
STARTED     109     111     109     107     190     189  
Treated     104     110     107     104     186     171  
COMPLETED     54     53     47     56     92     79  
NOT COMPLETED     55     58     62     51     98     110  
Lack of Efficacy                 35                 48                 48                 43                 71                 79  
Adverse Event                 2                 1                 3                 0                 3                 0  
Death                 0                 0                 0                 0                 1                 0  
Withdrawal by Subject                 4                 1                 5                 1                 12                 4  
complicating disease                 1                 1                 2                 0                 1                 0  
error                 2                 1                 1                 1                 1                 1  
maximum dose reached                 0                 1                 0                 0                 1                 0  
unknown/not specify                 3                 4                 1                 3                 3                 5  
not start protocol therapy                 5                 1                 2                 3                 4                 18  
alternative therapy                 3                 0                 0                 0                 1                 3  



  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.
All patients regardless of eligibility and treatment status

Reporting Groups
  Description
Arm I (GM-CSF, Peptide Vaccine)

Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC

peptide vaccine: Given SC

Arm II (GM-CSF Placebo, Peptide Vaccine)

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

peptide vaccine: Given SC

GM-CSF placebo: Given SC

Arm III (GM-CSF, Peptide Placebo)

Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC

peptide placebo: Given SC

Arm IV (GM-CSF Placebo, Peptide Placebo)

Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

GM-CSF placebo: Given SC

peptide placebo: Given SC

Arm V (GM-CSF)

Patients receive GM-CSF (sargramostim) SC on days 1-14.

sargramostim: Given SC

Arm VI (GM-CSF Placebo)

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.

GM-CSF placebo: Given SC

Total Total of all reporting groups

Baseline Measures
    Arm I (GM-CSF, Peptide Vaccine)     Arm II (GM-CSF Placebo, Peptide Vaccine)     Arm III (GM-CSF, Peptide Placebo)     Arm IV (GM-CSF Placebo, Peptide Placebo)     Arm V (GM-CSF)     Arm VI (GM-CSF Placebo)     Total  
Number of Participants  
[units: participants]
  109     111     109     107     190     189     815  
Age  
[units: years]
Median ( Full Range )
  60  
  ( 27 to 83 )  
  56  
  ( 22 to 82 )  
  57  
  ( 23 to 87 )  
  58  
  ( 23 to 82 )  
  60  
  ( 19 to 88 )  
  57  
  ( 19 to 87 )  
  58  
  ( 19 to 88 )  
Gender [1]
[units: participants]
             
Female     48     45     45     39     77     77     331  
Male     61     66     64     68     112     112     483  
[1] One patient on arm V had missing data for gender. Hence, a total of 189 patients on arm V reported gender.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years ]

2.  Primary:   Recurrence Free Survival   [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years ]

3.  Secondary:   Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients   [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years ]

4.  Secondary:   Recurrence Free Survival in HLA-A2 Positive Patients   [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years ]

5.  Secondary:   5-year Overall Survival Rate   [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years ]

6.  Secondary:   5-year Recurrence Free Survival Rate   [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 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: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01989572     History of Changes
Obsolete Identifiers: NCT00005034
Other Study ID Numbers: NCI-2013-02101, E4697, U10CA021115
Study First Received: November 18, 2013
Results First Received: July 22, 2014
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration