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Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00071981
First received: November 4, 2003
Last updated: October 6, 2015
Last verified: October 2015
Results First Received: November 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma (Skin)
Interventions: Biological: incomplete Freund's adjuvant
Biological: melanoma helper peptide vaccine
Biological: multi-epitope melanoma peptide vaccine
Biological: sargramostim
Biological: tetanus peptide melanoma vaccine

  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
This study was activated on March 21, 2005, and terminated on January 12, 2009 with the final accrual of 175 patients.22 ECOG institutions participated in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study involved a pre-registration before randomization. For patients with locally-typed HLA status, randomization immediately followed pre-registration. For central evaluation of HLA status, samples were submitted after pre-registration, and results of the evaluation must have been received from the central laboratory prior to randomization

Reporting Groups
  Description
Arm I (12MP)

Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.

multi-epitope melanoma peptide vaccine : Given by injection

incomplete Freund's adjuvant : Given by injection

sargramostim : Given by injection

Arm II (12MP/Tet)

Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.

multi-epitope melanoma peptide vaccine : Given by injection

incomplete Freund's adjuvant : Given by injection

sargramostim : Given by injection

tetanus peptide melanoma vaccine : Given by injection

Arm III (12MP/6MHP)

Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.

multi-epitope melanoma peptide vaccine : Given by injection

incomplete Freund's adjuvant : Given by injection

sargramostim : Given by injection

melanoma helper peptide vaccine : Given by injection

Arm IV (6MHP)

Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.

incomplete Freund's adjuvant : Given by injection

sargramostim : Given by injection

melanoma helper peptide vaccine : Given by injection


Participant Flow:   Overall Study
    Arm I (12MP)   Arm II (12MP/Tet)   Arm III (12MP/6MHP)   Arm IV (6MHP)
STARTED   47   43   37   48 
Eligible   43   36   33   42 
Treated   45   38   36   48 
Eligible and Treated   41   33   32   42 
Have CTL Response Data   40   30   29   41 
Have Helper T Cell Response Data   37   27   25   39 
COMPLETED   1   2   0   3 
NOT COMPLETED   46   41   37   45 
Lack of Efficacy                37                29                30                43 
Adverse Event                4                4                3                1 
Death                0                0                1                1 
Withdrawal by Subject                3                1                0                0 
No protocol therapy                2                5                1                0 
others (not specified in the study)                0                2                2                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
Arm I (12MP)

Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.

multi-epitope melanoma peptide vaccine : Given by injection

incomplete Freund's adjuvant : Given by injection

sargramostim : Given by injection

Arm II (12MP/Tet)

Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.

multi-epitope melanoma peptide vaccine : Given by injection

incomplete Freund's adjuvant : Given by injection

sargramostim : Given by injection

tetanus peptide melanoma vaccine : Given by injection

Arm III (12MP/6MHP)

Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.

multi-epitope melanoma peptide vaccine : Given by injection

incomplete Freund's adjuvant : Given by injection

sargramostim : Given by injection

melanoma helper peptide vaccine : Given by injection

Arm IV (6MHP)

Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.

incomplete Freund's adjuvant : Given by injection

sargramostim : Given by injection

melanoma helper peptide vaccine : Given by injection

Total Total of all reporting groups

Baseline Measures
   Arm I (12MP)   Arm II (12MP/Tet)   Arm III (12MP/6MHP)   Arm IV (6MHP)   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   33   32   42   148 
Age 
[Units: Years]
Median (Full Range)
 65 
 (35 to 86) 
 69 
 (31 to 88) 
 66 
 (32 to 89) 
 64 
 (40 to 82) 
 66 
 (31 to 89) 
Gender 
[Units: Participants]
         
Female   18   14   11   17   60 
Male   23   19   21   25   88 
Region of Enrollment 
[Units: Participants]
         
United States   41   33   32   42   148 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cytotoxic T-cell Lymphocytes (CTL) Response Rate   [ Time Frame: Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8 ]

2.  Secondary:   Helper T-cells Response to 6MHP   [ Time Frame: Immune response was assessed at pre-registration, in weeks 1,3,5,7,8 ]

3.  Secondary:   Helper T Cell Response to Tetanus   [ Time Frame: Immune response was assessed at pre-registration, in weeks 1,3,5,7,8 ]

4.  Secondary:   Objective Response Rate   [ Time Frame: Tumor response was assessed in weeks 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 6 months after last vaccination ]

5.  Secondary:   Median Overall Survival (OS)   [ Time Frame: assessed every 3 month within 2 years and every 6 months betwen 2 and 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 NOT 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.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office
phone: 617-632-3012



Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00071981     History of Changes
Obsolete Identifiers: NCT00464152
Other Study ID Numbers: CDR0000335055
U10CA021115 ( US NIH Grant/Contract Award Number )
E1602 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
Study First Received: November 4, 2003
Results First Received: November 24, 2012
Last Updated: October 6, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration