Trial Outcomes & Findings for Peptide Vaccination for Patients at High Risk for Recurrent Melanoma (NCT NCT00059475)
NCT ID: NCT00059475
Last Updated: 2012-10-23
Results Overview
Immunologic monitoring will be conducted using in vitro sensitization assays. The immunologic response in these assays will be considered positive if at least a two-fold increase in vaccine specific interferon gamma (y-IFN) secretion is seen between post vaccination specimens compared to the pre vaccination specimens.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
138 participants
Primary outcome timeframe
11 months
Results posted on
2012-10-23
Participant Flow
subjects were accrued to this trial.
Participant milestones
| Measure |
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)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
2
|
24
|
3
|
33
|
2
|
34
|
7
|
|
Overall Study
COMPLETED
|
33
|
2
|
24
|
3
|
33
|
2
|
34
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Peptide Vaccination for Patients at High Risk for Recurrent Melanoma
Baseline characteristics by cohort
| Measure |
Adj-2 MART-1: 27-35
n=33 Participants
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
n=2 Participants
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
n=24 Participants
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)
n=3 Participants
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
n=33 Participants
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)
n=2 Participants
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
n=34 Participants
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
n=7 Participants
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)
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
126 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
|
Age Continuous
|
44.8 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 3.8 • n=4 Participants
|
47.5 years
STANDARD_DEVIATION 13.0 • n=21 Participants
|
52.0 years
STANDARD_DEVIATION 8.5 • n=8 Participants
|
44.9 years
STANDARD_DEVIATION 11.4 • n=8 Participants
|
48.0 years
STANDARD_DEVIATION 8.5 • n=24 Participants
|
47.55 years
STANDARD_DEVIATION 10.18 • n=42 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
54 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
84 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
137 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
137 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
2 participants
n=7 Participants
|
24 participants
n=5 Participants
|
3 participants
n=4 Participants
|
33 participants
n=21 Participants
|
2 participants
n=8 Participants
|
34 participants
n=8 Participants
|
7 participants
n=24 Participants
|
138 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The number of participants analyzed and results are correct. We do not have the immunologic response rate data for all patients.
Immunologic monitoring will be conducted using in vitro sensitization assays. The immunologic response in these assays will be considered positive if at least a two-fold increase in vaccine specific interferon gamma (y-IFN) secretion is seen between post vaccination specimens compared to the pre vaccination specimens.
Outcome measures
| Measure |
Adj-2 MART-1: 27-35
n=13 Participants
melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
|
Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4
n=13 Participants
27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
|
Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4
n=13 Participants
melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
|
Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4
n=8 Participants
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 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)
|
|---|---|---|---|---|---|---|---|---|
|
Immunologic Response Rate
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 yearsPopulation: The number of participants analyzed and results are correct. We do not have the response rate data for all patients.
Response is measured from the time measurement criteria are first met for complete response (CR) or partial response (PR) (whichever is first) until the first date that recurrent disease is objectively documented. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Adj-2 MART-1: 27-35
n=2 Participants
melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
|
Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4
n=3 Participants
27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
|
Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4
n=2 Participants
melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
|
Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4
n=7 Participants
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 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)
|
|---|---|---|---|---|---|---|---|---|
|
Response Rate
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 11 monthsHere are the number of participants with adverse events. For details about the adverse events see the adverse event module.
Outcome measures
| Measure |
Adj-2 MART-1: 27-35
n=33 Participants
melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
|
Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4
n=2 Participants
27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
|
Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4
n=24 Participants
melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
|
Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4
n=3 Participants
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 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4
n=33 Participants
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)
n=2 Participants
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
n=34 Participants
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
n=7 Participants
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)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
31 Participants
|
2 Participants
|
20 Participants
|
3 Participants
|
32 Participants
|
2 Participants
|
30 Participants
|
7 Participants
|
Adverse Events
Adj-2 MART-1: 27-35
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Adj-2 HD IL-2 After MART-1: 27-35
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adj-2 MART-1: 27-35
n=33 participants at risk
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
n=2 participants at risk
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
n=24 participants at risk
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)
n=3 participants at risk
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
n=33 participants at risk
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)
n=2 participants at risk
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
n=34 participants at risk
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
n=7 participants at risk
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)
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
50.0%
1/2 • Number of events 1
|
0.00%
0/34
|
0.00%
0/7
|
|
Cardiac disorders
Cardiac troponin I increased
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
50.0%
1/2 • Number of events 1
|
0.00%
0/34
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Creatine phosphokinase increased
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
50.0%
1/2 • Number of events 1
|
0.00%
0/34
|
0.00%
0/7
|
Other adverse events
| Measure |
Adj-2 MART-1: 27-35
n=33 participants at risk
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
n=2 participants at risk
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
n=24 participants at risk
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)
n=3 participants at risk
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
n=33 participants at risk
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)
n=2 participants at risk
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
n=34 participants at risk
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
n=7 participants at risk
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)
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Chills
|
6.1%
2/33 • Number of events 2
|
0.00%
0/2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/3
|
3.0%
1/33 • Number of events 1
|
0.00%
0/2
|
0.00%
0/34
|
0.00%
0/7
|
|
General disorders
Fatigue
|
9.1%
3/33 • Number of events 3
|
50.0%
1/2 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
12.1%
4/33 • Number of events 6
|
0.00%
0/2
|
11.8%
4/34 • Number of events 5
|
57.1%
4/7 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.0%
1/33 • Number of events 1
|
0.00%
0/2
|
0.00%
0/24
|
0.00%
0/3
|
3.0%
1/33 • Number of events 1
|
0.00%
0/2
|
0.00%
0/34
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
93.9%
31/33 • Number of events 90
|
0.00%
0/2
|
83.3%
20/24 • Number of events 66
|
0.00%
0/3
|
97.0%
32/33 • Number of events 94
|
0.00%
0/2
|
85.3%
29/34 • Number of events 89
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
9.1%
3/33 • Number of events 3
|
0.00%
0/2
|
16.7%
4/24 • Number of events 6
|
0.00%
0/3
|
6.1%
2/33 • Number of events 2
|
0.00%
0/2
|
14.7%
5/34 • Number of events 5
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
12.1%
4/33 • Number of events 4
|
0.00%
0/2
|
20.8%
5/24 • Number of events 5
|
0.00%
0/3
|
15.2%
5/33 • Number of events 6
|
0.00%
0/2
|
20.6%
7/34 • Number of events 8
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
2/33 • Number of events 2
|
0.00%
0/2
|
8.3%
2/24 • Number of events 2
|
0.00%
0/3
|
12.1%
4/33 • Number of events 6
|
0.00%
0/2
|
5.9%
2/34 • Number of events 2
|
0.00%
0/7
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/33
|
50.0%
1/2 • Number of events 2
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
50.0%
1/2 • Number of events 1
|
0.00%
0/34
|
14.3%
1/7 • Number of events 2
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/33
|
50.0%
1/2 • Number of events 1
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/34
|
0.00%
0/7
|
|
Vascular disorders
Hypotension
|
0.00%
0/33
|
50.0%
1/2 • Number of events 4
|
0.00%
0/24
|
33.3%
1/3 • Number of events 1
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/34
|
42.9%
3/7 • Number of events 3
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
0.00%
0/33
|
50.0%
1/2 • Number of events 1
|
0.00%
0/24
|
0.00%
0/3
|
3.0%
1/33 • Number of events 1
|
0.00%
0/2
|
0.00%
0/34
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
0.00%
0/33
|
50.0%
1/2 • Number of events 1
|
0.00%
0/24
|
0.00%
0/3
|
3.0%
1/33 • Number of events 1
|
0.00%
0/2
|
0.00%
0/34
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Bilirubin increased
|
0.00%
0/33
|
50.0%
1/2 • Number of events 1
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/34
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Confusion
|
0.00%
0/33
|
50.0%
1/2 • Number of events 2
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
100.0%
2/2 • Number of events 2
|
0.00%
0/34
|
57.1%
4/7 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/33
|
50.0%
1/2 • Number of events 2
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/34
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
33.3%
1/3 • Number of events 1
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/34
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Creatinine increased
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
66.7%
2/3 • Number of events 5
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/34
|
28.6%
2/7 • Number of events 5
|
|
Cardiac disorders
Chest pain
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
33.3%
1/3 • Number of events 1
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/34
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
0.00%
0/3
|
9.1%
3/33 • Number of events 3
|
0.00%
0/2
|
2.9%
1/34 • Number of events 1
|
14.3%
1/7 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33
|
0.00%
0/2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/3
|
6.1%
2/33 • Number of events 2
|
0.00%
0/2
|
5.9%
2/34 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
0.00%
0/3
|
3.0%
1/33 • Number of events 1
|
0.00%
0/2
|
2.9%
1/34 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Anticipated Dose Limiting Toxicity
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/34
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/34
|
0.00%
0/7
|
|
Reproductive system and breast disorders
Abdominal pain
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/34
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/34
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Low urine output
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/24
|
0.00%
0/3
|
0.00%
0/33
|
0.00%
0/2
|
0.00%
0/34
|
14.3%
1/7 • Number of events 2
|
Additional Information
Steven A. Rosenberg, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-496-6375
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place