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

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)