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

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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
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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)