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  
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
  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
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

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)

Other 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, other (not including serious) adverse events                  
# participants affected / at risk     31/33     2/2     20/24     3/3     32/33     2/2     30/34     7/7  
Blood and lymphatic system disorders                  
Platelet count decreased † 1                
# participants affected / at risk     0/33 (0.00%)     0/2 (0.00%)     0/24 (0.00%)     1/3 (33.33%)     0/33 (0.00%)     0/2 (0.00%)     0/34 (0.00%)     0/7 (0.00%)  
# events     0     0     0     1     0     0     0     0  
Cardiac disorders                  
Sinus tachycardia † 1                
# participants affected / at risk     0/33 (0.00%)     1/2 (50.00%)     0/24 (0.00%)     0/3 (0.00%)     0/33 (0.00%)     1/2 (50.00%)     0/34 (0.00%)     1/7 (14.29%)  
# events     0     2     0     0     0     1     0     2  
Ventricular arrhythmia † 1                
# participants affected / at risk     0/33 (0.00%)     1/2 (50.00%)     0/24 (0.00%)     0/3 (0.00%)     0/33 (0.00%)     0/2 (0.00%)     0/34 (0.00%)     0/7 (0.00%)  
# events     0     1     0     0     0     0     0     0  
Chest pain † 1                
# participants affected / at risk     0/33 (0.00%)     0/2 (0.00%)     0/24 (0.00%)     1/3 (33.33%)     0/33 (0.00%)     0/2 (0.00%)     0/34 (0.00%)     0/7 (0.00%)  
# events     0     0     0     1     0     0     0     0  
Gastrointestinal disorders                  
Diarrhea † 1                
# participants affected / at risk     0/33 (0.00%)     0/2 (0.00%)     0/24 (0.00%)     0/3 (0.00%)     3/33 (9.09%)     0/2 (0.00%)     1/34 (2.94%)     1/7 (14.29%)  
# events     0     0     0     0     3     0     1     2  
Nausea † 1                
# participants affected / at risk     0/33 (0.00%)     0/2 (0.00%)     1/24 (4.17%)     0/3 (0.00%)     2/33 (6.06%)     0/2 (0.00%)     2/34 (5.88%)     0/7 (0.00%)  
# events     0     0     1     0     2     0     2     0  
Vomiting † 1                
# participants affected / at risk     0/33 (0.00%)     0/2 (0.00%)     0/24 (0.00%)     0/3 (0.00%)     1/33 (3.03%)     0/2 (0.00%)     1/34 (2.94%)     0/7 (0.00%)  
# events     0     0     0     0     1     0     1     0  
General disorders                  
Chills † 1                
# participants affected / at risk     2/33 (6.06%)     0/2 (0.00%)     1/24 (4.17%)     0/3 (0.00%)     1/33 (3.03%)     0/2 (0.00%)     0/34 (0.00%)     0/7 (0.00%)  
# events     2     0     1     0     1     0     0     0  
Fatigue † 1                
# participants affected / at risk     3/33 (9.09%)     1/2 (50.00%)     1/24 (4.17%)     1/3 (33.33%)     4/33 (12.12%)     0/2 (0.00%)     4/34 (11.76%)     4/7 (57.14%)  
# events     3     1     1     1     6     0     5     5  
Anticipated Dose Limiting Toxicity † 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%)     0/2 (0.00%)     0/34 (0.00%)     1/7 (14.29%)  
# events     0     0     0     0     0     0     0     1  
Metabolism and nutrition disorders                  
Alanine aminotransferase increased † 1                
# participants affected / at risk     0/33 (0.00%)     1/2 (50.00%)     0/24 (0.00%)     0/3 (0.00%)     1/33 (3.03%)     0/2 (0.00%)     0/34 (0.00%)     0/7 (0.00%)  
# events     0     1     0     0     1     0     0     0  
Aspartate aminotransferase increased † 1                
# participants affected / at risk     0/33 (0.00%)     1/2 (50.00%)     0/24 (0.00%)     0/3 (0.00%)     1/33 (3.03%)     0/2 (0.00%)     0/34 (0.00%)     0/7 (0.00%)  
# events     0     1     0     0     1     0     0     0  
Bilirubin increased † 1                
# participants affected / at risk     0/33 (0.00%)     1/2 (50.00%)     0/24 (0.00%)     0/3 (0.00%)     0/33 (0.00%)     0/2 (0.00%)     0/34 (0.00%)     1/7 (14.29%)  
# events     0     1     0     0     0     0     0     1  
Creatinine increased † 1                
# participants affected / at risk     0/33 (0.00%)     0/2 (0.00%)     0/24 (0.00%)     2/3 (66.67%)     0/33 (0.00%)     0/2 (0.00%)     0/34 (0.00%)     2/7 (28.57%)  
# events     0     0     0     5     0     0     0     5  
Musculoskeletal and connective tissue disorders                  
Myalgia † 1                
# participants affected / at risk     2/33 (6.06%)     0/2 (0.00%)     2/24 (8.33%)     0/3 (0.00%)     4/33 (12.12%)     0/2 (0.00%)     2/34 (5.88%)     0/7 (0.00%)  
# events     2     0     2     0     6     0     2     0  
Joint pain † 1                
# participants affected / at risk     0/33 (0.00%)     1/2 (50.00%)     0/24 (0.00%)     0/3 (0.00%)     0/33 (0.00%)     0/2 (0.00%)     0/34 (0.00%)     0/7 (0.00%)  
# events     0     2     0     0     0     0     0     0  
Nervous system disorders                  
Confusion † 1                
# participants affected / at risk     0/33 (0.00%)     1/2 (50.00%)     0/24 (0.00%)     0/3 (0.00%)     0/33 (0.00%)     2/2 (100.00%)     0/34 (0.00%)     4/7 (57.14%)  
# events     0     2     0     0     0     2     0     4  
Psychiatric disorders                  
Depression † 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%)     0/2 (0.00%)     0/34 (0.00%)     0/7 (0.00%)  
# events     0     0     0     0     0     0     0     0  
Renal and urinary disorders                  
Low urine output † 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%)     0/2 (0.00%)     0/34 (0.00%)     1/7 (14.29%)  
# events     0     0     0     0     0     0     0     2  
Reproductive system and breast disorders                  
Abdominal pain † 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%)     0/2 (0.00%)     0/34 (0.00%)     1/7 (14.29%)  
# events     0     0     0     0     0     0     0     1  
Respiratory, thoracic and mediastinal disorders                  
Dyspnea † 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%)     0/2 (0.00%)     0/34 (0.00%)     1/7 (14.29%)  
# events     0     0     0     0     0     0     0     1  
Skin and subcutaneous tissue disorders                  
Sweating † 1                
# participants affected / at risk     1/33 (3.03%)     0/2 (0.00%)     0/24 (0.00%)     0/3 (0.00%)     1/33 (3.03%)     0/2 (0.00%)     0/34 (0.00%)     0/7 (0.00%)  
# events     1     0     0     0     1     0     0     0  
Injection site reaction † 1                
# participants affected / at risk     31/33 (93.94%)     0/2 (0.00%)     20/24 (83.33%)     0/3 (0.00%)     32/33 (96.97%)     0/2 (0.00%)     29/34 (85.29%)     0/7 (0.00%)  
# events     90     0     66     0     94     0     89     0  
Pruritis † 1                
# participants affected / at risk     3/33 (9.09%)     0/2 (0.00%)     4/24 (16.67%)     0/3 (0.00%)     2/33 (6.06%)     0/2 (0.00%)     5/34 (14.71%)     0/7 (0.00%)  
# events     3     0     6     0     2     0     5     0  
Rash desquamating † 1                
# participants affected / at risk     4/33 (12.12%)     0/2 (0.00%)     5/24 (20.83%)     0/3 (0.00%)     5/33 (15.15%)     0/2 (0.00%)     7/34 (20.59%)     1/7 (14.29%)  
# events     4     0     5     0     6     0     8     1  
Vascular disorders                  
Hypotension † 1                
# participants affected / at risk     0/33 (0.00%)     1/2 (50.00%)     0/24 (0.00%)     1/3 (33.33%)     0/33 (0.00%)     0/2 (0.00%)     0/34 (0.00%)     3/7 (42.86%)  
# events     0     4     0     1     0     0     0     3  
Events were collected by systematic assessment
1 Term from vocabulary, CTCv2.0



  Limitations and Caveats
  Hide 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
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