Trial Outcomes & Findings for Vaccine Therapy in Treating HLA-A2 Positive Patients With Melanoma (NCT NCT00003895)
NCT ID: NCT00003895
Last Updated: 2017-02-20
Results Overview
Frequency measures obtained from each assay will be transformed to (common) logs for purposes of analysis. Repeated measures analyses will be performed on longitudinal data to assess patients' immune response profiles over time. Comparability of assay methods will be assessed with correlation analyses, regression analyses, standard parametric and nonparametric tests, and agreement methods. Pre- and post-immunization T-cell immunity to g209-2M peptide, to HPV16E7 peptide, and to a negative control HLA-A2 HIV peptide (pol) were assessed using HLA-A2/peptide tetramer-specific binding analysis. Within-subject analyses were performed to determine differences between pre- and postimmunization responses to the g209 -2M and HPV peptides and to the negative control HIV peptide after completion of 6 months of vaccination. Pre- versus postimmunization response differences were used as criterion measures in between-group (among subjects) analyses.
COMPLETED
PHASE2
36 participants
Baseline to 6 months
2017-02-20
Participant Flow
Participant milestones
| Measure |
gp100:209-217(210M)and HPV 16 E7:12-20 (Every 2 Weeks)
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies
|
gp100:209-217(210M) and HPV 16 E7:12-20 (Every 3 Weeks)
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
gp100:209-217(210M)and HPV 16 E7:12-20 (Every 2 Weeks)
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies
|
gp100:209-217(210M) and HPV 16 E7:12-20 (Every 3 Weeks)
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Patient Vacation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
Vaccine Therapy in Treating HLA-A2 Positive Patients With Melanoma
Baseline characteristics by cohort
| Measure |
Arm A (Every 2 Weeks)
n=18 Participants
|
Arm B (Every 3 Weeks)
n=18 Participants
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Gender
Female
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Gender
Male
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Patients were randomly assigned to two different vaccination schedules: group A received vaccinations every 2 weeks for 6 months (13 total injections), and group B received vaccinations every 3 weeks for 6 months (nine total vaccinations).
Frequency measures obtained from each assay will be transformed to (common) logs for purposes of analysis. Repeated measures analyses will be performed on longitudinal data to assess patients' immune response profiles over time. Comparability of assay methods will be assessed with correlation analyses, regression analyses, standard parametric and nonparametric tests, and agreement methods. Pre- and post-immunization T-cell immunity to g209-2M peptide, to HPV16E7 peptide, and to a negative control HLA-A2 HIV peptide (pol) were assessed using HLA-A2/peptide tetramer-specific binding analysis. Within-subject analyses were performed to determine differences between pre- and postimmunization responses to the g209 -2M and HPV peptides and to the negative control HIV peptide after completion of 6 months of vaccination. Pre- versus postimmunization response differences were used as criterion measures in between-group (among subjects) analyses.
Outcome measures
| Measure |
Arm A (Every 2 Weeks, gp100:209-217(210M) and HPV 16 E7:12-20)
n=14 Participants
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies
|
Arm B (Every 3 Weeks, gp100:209-217(210M) + HPV 16 E7:12-20)
n=15 Participants
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
T Cell Immunity to gp100 Peptide and to E7 12-20 Papilloma Virus Peptide
pre-treatment %gp100 g209-2M-specific T cells
|
0.02 % of CD8+ T cells
Interval 0.01 to 0.03
|
0.01 % of CD8+ T cells
Interval 0.0 to 0.02
|
|
T Cell Immunity to gp100 Peptide and to E7 12-20 Papilloma Virus Peptide
Post-treatment % gp100 g209-2M-specific T cells
|
0.97 % of CD8+ T cells
Interval 0.37 to 1.57
|
0.98 % of CD8+ T cells
Interval 0.04 to 1.92
|
|
T Cell Immunity to gp100 Peptide and to E7 12-20 Papilloma Virus Peptide
Pre-Treatment % HPV16:E7 12-20-specific T cells
|
0.61 % of CD8+ T cells
Interval 0.0 to 1.27
|
0.1 % of CD8+ T cells
Interval 0.04 to 0.16
|
|
T Cell Immunity to gp100 Peptide and to E7 12-20 Papilloma Virus Peptide
Post-Treatment % HPV16:E7 12-20-specific T cells
|
0.68 % of CD8+ T cells
Interval 0.31 to 1.05
|
1.34 % of CD8+ T cells
Interval 0.85 to 1.82
|
Adverse Events
Arm A (Every 2 Weeks)
Arm B (Every 3 Weeks)
Serious adverse events
| Measure |
Arm A (Every 2 Weeks)
n=18 participants at risk
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies
|
Arm B (Every 3 Weeks)
n=18 participants at risk
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Nervous system disorders
CVA
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
Other adverse events
| Measure |
Arm A (Every 2 Weeks)
n=18 participants at risk
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies
|
Arm B (Every 3 Weeks)
n=18 participants at risk
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
100.0%
18/18 • Number of events 18
|
94.4%
17/18 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
6/18 • Number of events 6
|
33.3%
6/18 • Number of events 6
|
|
Nervous system disorders
Anxiety
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Pain
|
33.3%
6/18 • Number of events 6
|
27.8%
5/18 • Number of events 5
|
|
General disorders
Fatigue
|
38.9%
7/18 • Number of events 7
|
72.2%
13/18 • Number of events 13
|
|
Nervous system disorders
Neuropathy
|
16.7%
3/18 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Depression
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Endocrine disorders
Endocrine-Other
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Nausea
|
38.9%
7/18 • Number of events 7
|
16.7%
3/18 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • Number of events 3
|
11.1%
2/18 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.8%
5/18 • Number of events 5
|
27.8%
5/18 • Number of events 5
|
|
General disorders
Chills
|
44.4%
8/18 • Number of events 8
|
33.3%
6/18 • Number of events 6
|
|
Vascular disorders
Edema
|
5.6%
1/18 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
3/18 • Number of events 3
|
16.7%
3/18 • Number of events 3
|
|
Gastrointestinal disorders
Dysguesia
|
11.1%
2/18 • Number of events 2
|
0.00%
0/18
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
4/18 • Number of events 4
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Stomatitis
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Insomnia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
General disorders
Fever
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/18
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
Additional Information
Walter J. Urba, MD, PhD; Physician Director of Research
Providence Cancer Center, Earle A. Chiles Research Institute, Robert W. Franz Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60