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Peptide Vaccination for Patients at High Risk for Recurrent Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven Rosenberg, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00059475
First received: April 26, 2003
Last updated: October 17, 2012
Last verified: October 2012
Results First Received: March 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma
Interventions: Drug: Glycoprotein 100 (GP100): 209-217 (210M)
Drug: Interleukin-2 (IL-2)
Drug: Montanide ISA 51
Drug: Melanoma antigen recognized by T-cells (MART)-1: 27-35
Drug: 27-35 (27L): melanoma antigen recognized by T-cells (MART)-1
Drug: melanoma antigen recognized by T-cells (MART)-1: 26-35(27L)

  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
subjects were accrued to this trial.

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
Adj-2 MART-1: 27-35 melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
Adj-2 HD IL-2 After MART-1: 27-35 High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4 27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer) High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4 melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer) High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4 27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)

Participant Flow:   Overall Study
    Adj-2 MART-1: 27-35   Adj-2 HD IL-2 After MART-1: 27-35   Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4   Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)   Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4   Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)   Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4   Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M
STARTED   33   2   24   3   33   2   34   7 
COMPLETED   33   2   24   3   33   2   34   7 
NOT COMPLETED   0   0   0   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
Adj-2 MART-1: 27-35 melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
Adj-2 HD IL-2 After MART-1: 27-35 High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4 27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer) High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4 melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer) High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4 27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
Total Total of all reporting groups

Baseline Measures
   Adj-2 MART-1: 27-35   Adj-2 HD IL-2 After MART-1: 27-35   Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4   Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)   Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4   Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)   Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4   Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   2   24   3   33   2   34   7   138 
Age 
[Units: Participants]
                 
<=18 years   0   0   0   0   0   0   1   0   1 
Between 18 and 65 years   30   2   20   3   29   2   33   7   126 
>=65 years   3   0   4   0   4   0   0   0   11 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.8  (14.9)   42.0  (8.5)   48.5  (12.9)   52.7  (3.8)   47.5  (13.0)   52.0  (8.5)   44.9  (11.4)   48.0  (8.5)   47.55  (10.18) 
Gender 
[Units: Participants]
                 
Female   13   2   6   0   14   0   15   4   54 
Male   20   0   18   3   19   2   19   3   84 
Ethnicity (NIH/OMB) 
[Units: Participants]
                 
Hispanic or Latino   0   0   0   0   1   0   0   0   1 
Not Hispanic or Latino   33   2   24   3   32   2   34   7   137 
Unknown or Not Reported   0   0   0   0   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
                 
American Indian or Alaska Native   0   0   0   0   0   0   0   0   0 
Asian   0   0   0   0   0   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0   0   0   0   0 
Black or African American   0   0   1   0   0   0   0   0   1 
White   33   2   23   3   33   2   34   7   137 
More than one race   0   0   0   0   0   0   0   0   0 
Unknown or Not Reported   0   0   0   0   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
                 
United States   33   2   24   3   33   2   34   7   138 


  Outcome Measures
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1.  Primary:   Immunologic Response Rate   [ Time Frame: 11 months ]

Measure Type Primary
Measure Title Immunologic Response Rate
Measure Description Immunologic monitoring will be conducted using in vitro sensitization assays. The immunologic response in these assays will be considered positive if at least a two-fold increase in vaccine specific interferon gamma (y-IFN) secretion is seen between post vaccination specimens compared to the pre vaccination specimens.
Time Frame 11 months  
Safety Issue No  

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.
The number of participants analyzed and results are correct. We do not have the immunologic response rate data for all patients.

Reporting Groups
  Description
Adj-2 MART-1: 27-35 melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4 27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4 melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4 27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).

Measured Values
   Adj-2 MART-1: 27-35   Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4   Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4   Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4 
Participants Analyzed 
[Units: Participants]
 13   13   13   8 
Immunologic Response Rate 
[Units: Participants]
 7   1   0   0 

No statistical analysis provided for Immunologic Response Rate



2.  Primary:   Response Rate   [ Time Frame: 6 years ]

Measure Type Primary
Measure Title Response Rate
Measure Description Response is measured from the time measurement criteria are first met for complete response (CR) or partial response (PR) (whichever is first) until the first date that recurrent disease is objectively documented. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Time Frame 6 years  
Safety Issue No  

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.
The number of participants analyzed and results are correct. We do not have the response rate data for all patients.

Reporting Groups
  Description
Adj-2 HD IL-2 After MART-1: 27-35 High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer) High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer) High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)

Measured Values
   Adj-2 HD IL-2 After MART-1: 27-35   Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)   Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)   Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M 
Participants Analyzed 
[Units: Participants]
 2   3   2   7 
Response Rate 
[Units: Participants]
 1   1   0   1 

No statistical analysis provided for Response Rate



3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 11 months ]

Measure Type Secondary
Measure Title Number of Participants With Adverse Events
Measure Description Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.
Time Frame 11 months  
Safety Issue Yes  

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
Adj-2 MART-1: 27-35 melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
Adj-2 HD IL-2 After MART-1: 27-35 High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4 27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer) High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4 melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer) High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4 27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)

Measured Values
   Adj-2 MART-1: 27-35   Adj-2 HD IL-2 After MART-1: 27-35   Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4   Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)   Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4   Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)   Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4   Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M 
Participants Analyzed 
[Units: Participants]
 33   2   24   3   33   2   34   7 
Number of Participants With Adverse Events 
[Units: Participants]
 31   2   20   3   32   2   30   7 

No statistical analysis provided for Number of Participants With Adverse Events




  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.


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