We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Peptide Vaccination for Patients at High Risk for Recurrent Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00059475
First Posted: April 28, 2003
Last Update Posted: October 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steven Rosenberg, National Institutes of Health Clinical Center (CC)
Results First Submitted: March 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
  Show All Outcome Measures

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


  More Information