Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Metastatic Melanoma (NCT NCT00003224)
NCT ID: NCT00003224
Last Updated: 2014-11-20
Results Overview
Adverse events are monitored according to NCI/DCT Common Toxicity Criteria
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Up to 24 months after last vaccine
Results posted on
2014-11-20
Participant Flow
patients were enrolled at the University of Virginia
no enrolled patients were excluded.
Participant milestones
| Measure |
Group 1: Peptide 946 Plus QS-21
100 mcg peptide gp100 \[280-288\] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
|
Group 2. p946 Plus IFA
100 mcg peptide gp100 \[280-288\] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
|
Group 3: p946 Plus Tet-p Plus QS-21
100 mcg peptide gp100 \[280-288\],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
|
Group 4. p946, Tet-p Plus IFA
100 mcg peptide gp100 \[280-288\], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
|
Group 5: p946/Tet-p Plus QS-21
282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
|
Group 6. p946/Tet-p Plus IFA
282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
4
|
2
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
5
|
4
|
2
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Group 1: Peptide 946 Plus QS-21
n=4 Participants
100 mcg peptide gp100 \[280-288\] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
|
Group 2. p946 Plus IFA
n=5 Participants
100 mcg peptide gp100 \[280-288\] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
|
Group 3: p946 Plus Tet-p Plus QS-21
n=4 Participants
100 mcg peptide gp100 \[280-288\],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
|
Group 4. p946, Tet-p Plus IFA
n=2 Participants
100 mcg peptide gp100 \[280-288\], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
|
Group 5: p946/Tet-p Plus QS-21
n=4 Participants
282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
|
Group 6. p946/Tet-p Plus IFA
n=3 Participants
282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
|
Total
n=22 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 18.6 • n=7 Participants
|
44.3 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 17.7 • n=4 Participants
|
51.8 years
STANDARD_DEVIATION 14.9 • n=21 Participants
|
69.3 years
STANDARD_DEVIATION 7.5 • n=10 Participants
|
55.6 years
STANDARD_DEVIATION 16.1 • n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
3 participants
n=10 Participants
|
22 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 24 months after last vaccineAdverse events are monitored according to NCI/DCT Common Toxicity Criteria
Outcome measures
| Measure |
All QS-21
n=12 Participants
The toxicities are grouped for those receiving the vaccine adjuvant QS-21.
|
All Montanide ISA-51
n=10 Participants
The toxicities are grouped for those receiving the vaccine adjuvant IFA (Montanide ISA-51).
|
Group 3: p946 Plus Tet-p Plus QS-21
100 mcg peptide gp100 \[280-288\],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
|
Group 4. p946, Tet-p Plus IFA
100 mcg peptide gp100 \[280-288\], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
|
Group 5: p946/Tet-p Plus QS-21
282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
|
Group 6. p946/Tet-p Plus IFA
282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
|
|---|---|---|---|---|---|---|
|
Safety: Grade 3 Adverse Events
|
1 participants
|
0 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 months since enrollmentT cell responses to the p946 (gp100 \[280-288\]) peptide. All enrolled patients were assayed for immune response to the gp100 peptide by ELIspot assay after 14 days in vitro sensitization. The number with a response in each study arm is reported.
Outcome measures
| Measure |
All QS-21
n=4 Participants
The toxicities are grouped for those receiving the vaccine adjuvant QS-21.
|
All Montanide ISA-51
n=5 Participants
The toxicities are grouped for those receiving the vaccine adjuvant IFA (Montanide ISA-51).
|
Group 3: p946 Plus Tet-p Plus QS-21
n=4 Participants
100 mcg peptide gp100 \[280-288\],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
|
Group 4. p946, Tet-p Plus IFA
n=2 Participants
100 mcg peptide gp100 \[280-288\], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
|
Group 5: p946/Tet-p Plus QS-21
n=4 Participants
282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
|
Group 6. p946/Tet-p Plus IFA
n=3 Participants
282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
|
|---|---|---|---|---|---|---|
|
Immunogenicity of Each Vaccine Regimen
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: during vaccinationPopulation: All evaluable enrolled patients were assayed.
Proliferative response measured in participants using a tritiated thymidine incorporation assay with peripheral blood mononuclear cells (PBMC) stimulated with the tetanus peptide in vitro, and measured at 5 days after in vitro culture.
Outcome measures
| Measure |
All QS-21
n=3 Participants
The toxicities are grouped for those receiving the vaccine adjuvant QS-21.
|
All Montanide ISA-51
n=5 Participants
The toxicities are grouped for those receiving the vaccine adjuvant IFA (Montanide ISA-51).
|
Group 3: p946 Plus Tet-p Plus QS-21
n=3 Participants
100 mcg peptide gp100 \[280-288\],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
|
Group 4. p946, Tet-p Plus IFA
n=2 Participants
100 mcg peptide gp100 \[280-288\], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
|
Group 5: p946/Tet-p Plus QS-21
n=4 Participants
282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
|
Group 6. p946/Tet-p Plus IFA
n=3 Participants
282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
|
|---|---|---|---|---|---|---|
|
Number of Participants With a Proliferative Response to Tetanus Helper Peptide
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
4 participants
|
2 participants
|
Adverse Events
QS-21 Adjuvant
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Montanide ISA-51 Adjuvant
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QS-21 Adjuvant
n=12 participants at risk
The combination of participants from Arms 1, 3, and 5, all treated with peptides plus QS-21 adjuvant
|
Montanide ISA-51 Adjuvant
n=10 participants at risk
The combination of participants from Arms 2, 4, and 6, all treated with peptides plus Montanide ISA-51 adjuvant
|
|---|---|---|
|
Gastrointestinal disorders
Esophageal spasm, Grade 3
|
8.3%
1/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
0.00%
0/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
Other adverse events
| Measure |
QS-21 Adjuvant
n=12 participants at risk
The combination of participants from Arms 1, 3, and 5, all treated with peptides plus QS-21 adjuvant
|
Montanide ISA-51 Adjuvant
n=10 participants at risk
The combination of participants from Arms 2, 4, and 6, all treated with peptides plus Montanide ISA-51 adjuvant
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
grade 1-2 skin toxicity, especially pain
|
75.0%
9/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
30.0%
3/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
|
Skin and subcutaneous tissue disorders
skin, other
|
33.3%
4/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
0.00%
0/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
|
General disorders
Flu-like symptoms
|
16.7%
2/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
30.0%
3/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
|
Nervous system disorders
Headache
|
25.0%
3/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
10.0%
1/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
|
General disorders
Other pain
|
16.7%
2/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
0.00%
0/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
|
Gastrointestinal disorders
other gastrointestinal
|
16.7%
2/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
10.0%
1/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
|
Nervous system disorders
other neurological
|
8.3%
1/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
10.0%
1/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
10.0%
1/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
|
Investigations
Hematological
|
8.3%
1/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
0.00%
0/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
|
Nervous system disorders
Syncope
|
8.3%
1/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
0.00%
0/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
10.0%
1/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
|
Endocrine disorders
endocrine
|
0.00%
0/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
10.0%
1/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
|
Renal and urinary disorders
Urinary
|
0.00%
0/12
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
10.0%
1/10
Participants are reported for adverse events based on vaccine adjuvant received because the adverse events were considered primarily related to the adjuvant. Also, the gp100 peptide was included in all 6 study groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place