Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High-Risk Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven Rosenberg, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00273910
First received: January 7, 2006
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: High-Risk Melanoma
Interventions: Drug: gp100:209-217 (210M)
Drug: Montanide ISA-51
Drug: Imiquimod

  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
104 subjects were enrolled in 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-3 A2 gp209(2M) in IFA SQ (Vortex) gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex) gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
Adj-3 A2 gp209(2M) in Saline ID gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
Adj-3 A2 gp209(2M) in Saline ID + Imiquimod gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe) gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe) gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.

Participant Flow:   Overall Study
    Adj-3 A2 gp209(2M) in IFA SQ (Vortex)     Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)     Adj-3 A2 gp209(2M) in Saline ID     Adj-3 A2 gp209(2M) in Saline ID + Imiquimod     Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)     Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)  
STARTED     19     19     18     19     15     14  
COMPLETED     19     19     18     19     15     14  
NOT COMPLETED     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-3 A2 gp209(2M) in IFA SQ (Vortex) gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex) gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
Adj-3 A2 gp209(2M) in Saline ID gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
Adj-3 A2 gp209(2M) in Saline ID + Imiquimod gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe) gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe) gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
Total Total of all reporting groups

Baseline Measures
    Adj-3 A2 gp209(2M) in IFA SQ (Vortex)     Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)     Adj-3 A2 gp209(2M) in Saline ID     Adj-3 A2 gp209(2M) in Saline ID + Imiquimod     Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)     Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)     Total  
Number of Participants  
[units: participants]
  19     19     18     19     15     14     104  
Age  
[units: participants]
             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     19     19     18     19     13     14     102  
>=65 years     0     0     0     0     2     0     2  
Age  
[units: years]
Mean ± Standard Deviation
  46.9  ± 9.1     42.8  ± 10.4     48.8  ± 12.7     48.1  ± 10.2     51.7  ± 13.2     47.7  ± 8.3     47.6  ± 10.65  
Gender  
[units: participants]
             
Female     6     9     9     6     3     4     37  
Male     13     10     9     13     12     10     67  
Race/Ethnicity, Customized  
[units: Participants]
             
American Indian or Alaskan Natives     0     0     0     0     0     0     0  
Asian or Pacific Islander     1     0     0     0     0     0     1  
Native Hawaiian     0     0     0     0     0     0     0  
Black of non-Hispanic Origin     0     0     0     0     0     0     0  
Hispanic     0     0     0     0     0     0     0  
White of non-Hispanic Origin     18     19     18     19     15     14     103  
Other or Unknown     0     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
             
United States     19     19     18     19     15     14     104  



  Outcome Measures
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1.  Primary:   Immunologic Response Rate   [ Time Frame: 48 months ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 48 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
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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.


Results Point of Contact:  
Name/Title: Steven A. Rosenberg, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-4164
e-mail: sar@mail.nih.gov


Publications:

Responsible Party: Steven Rosenberg, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00273910     History of Changes
Obsolete Identifiers: NCT00304057
Other Study ID Numbers: 060069, 06-C-0069
Study First Received: January 7, 2006
Results First Received: March 30, 2012
Last Updated: October 17, 2012
Health Authority: United States: Federal Government