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Peptide Vaccination for Patients at High Risk for Recurrent Melanoma

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ClinicalTrials.gov Identifier: NCT00059475
Recruitment Status : Completed
First Posted : April 28, 2003
Results First Posted : August 14, 2012
Last Update Posted : October 23, 2012
Sponsor:
Information provided by (Responsible Party):
Steven Rosenberg, National Institutes of Health Clinical Center (CC)

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

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

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

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