Peptide Vaccination for Patients at High Risk for Recurrent Melanoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00059475 |
Recruitment Status
:
Completed
First Posted
: April 28, 2003
Results First Posted
: August 14, 2012
Last Update Posted
: October 23, 2012
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Steven Rosenberg, National Institutes of Health Clinical Center (CC)
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Study Type: | Interventional |
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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) |

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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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 | |
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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 | |
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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 |


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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