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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
History of Changes
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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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  
Number of Participants  
[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 ]
  Show Outcome Measure 1

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

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


  Serious Adverse Events
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Time Frame No text entered.
Additional Description 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)

Serious Adverse Events
    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, serious adverse events                  
# participants affected / at risk     0/33 (0.00%)     0/2 (0.00%)     0/24 (0.00%)     0/3 (0.00%)     0/33 (0.00%)     1/2 (50.00%)     0/34 (0.00%)     0/7 (0.00%)  
Cardiac disorders                  
Nodal arrhythmia † 1                
# participants affected / at risk     0/33 (0.00%)     0/2 (0.00%)     0/24 (0.00%)     0/3 (0.00%)     0/33 (0.00%)     1/2 (50.00%)     0/34 (0.00%)     0/7 (0.00%)  
# events     0     0     0     0     0     1     0     0  
Cardiac troponin I increased † 1                
# participants affected / at risk     0/33 (0.00%)     0/2 (0.00%)     0/24 (0.00%)     0/3 (0.00%)     0/33 (0.00%)     1/2 (50.00%)     0/34 (0.00%)     0/7 (0.00%)  
# events     0     0     0     0     0     1     0     0  
Metabolism and nutrition disorders                  
Creatine phosphokinase increased † 1                
# participants affected / at risk     0/33 (0.00%)     0/2 (0.00%)     0/24 (0.00%)     0/3 (0.00%)     0/33 (0.00%)     1/2 (50.00%)     0/34 (0.00%)     0/7 (0.00%)  
# events     0     0     0     0     0     1     0     0  
† Events were collected by systematic assessment
1 Term from vocabulary, CTCv2.0




  Other Adverse Events
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  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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Steven A. Rosenberg, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-6375
e-mail: nciirbadmin@mail.nih.gov


Publications:


Responsible Party: Steven Rosenberg, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00059475     History of Changes
Obsolete Identifiers: NCT00062218
Other Study ID Numbers: 030172, 03-C-0172
Study First Received: April 26, 2003
Results First Received: March 30, 2012
Last Updated: October 17, 2012
Health Authority: United States: Federal Government