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
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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


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

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

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


  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
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  More Information