Trial Outcomes & Findings for Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma (NCT NCT00003222)
NCT ID: NCT00003222
Last Updated: 2014-12-19
Results Overview
The primary end point for this trial was clinical response. This was assessed by measurement of assessable metastatic deposits by CT, MRI, or direct measure of cutaneous deposits. Baseline tumor measurements used for assessment of clinical response were those obtained most immediately before the first vaccine administration and within 6 weeks of protocol entry. Measurements were made and reviewed by a multidisciplinary team. The original protocol defined tumor response on the basis of changes in cross-sectional area calculated as the product of two perpendicular measures. However, since the initiation of this study, the Response Evaluation Criteria in Solid Tumors Group (RECIST) system was employed as the current standard for clinical trials, in which response is based on changes in maximum cross-sectional dimensions. Computed tomography scans of clinical responders were reviewed again by a senior faculty radiologist not otherwise involved in the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Weeks 0-6,12; Months 6,12 and 24
Results posted on
2014-12-19
Participant Flow
13 participants were assigned to each arm in Stage I. 14 additional participants were assigned in Stage II to study arm 2. Data are reported for stage I. Reporting is planned for stage II when data are available.
Participant milestones
| Measure |
Peptides Pulsed on Dendritic Cells
---peptides were pulsed on monocyte-derived dendritic cells cultures in GM-CSF and IL-4
|
Peptides in Sargramostim (GMCSF)-In-Montanide ISA-51 Adjuvant
---Peptides were administered in an emulsion of sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's) adjuvant
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
28
|
|
Overall Study
COMPLETED
|
13
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Peptides Pulsed on Dendritic Cells
---peptides were pulsed on monocyte-derived dendritic cells cultures in GM-CSF and IL-4
|
Peptides in Sargramostim (GMCSF)-In-Montanide ISA-51 Adjuvant
---Peptides were administered in an emulsion of sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's) adjuvant
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
Peptides Pulsed on Dendritic Cells
n=13 Participants
|
Peptides in GMCSF-in-adjuvant
n=28 Participants
|
Total
n=41 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
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 13 • n=5 Participants
|
55 years
STANDARD_DEVIATION 11 • n=7 Participants
|
55 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
28 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 0-6,12; Months 6,12 and 24Population: The analysis of this outcome measure was performed on subjects enrolled in Stage I of the trial, which included 13 subjects in each arm.
The primary end point for this trial was clinical response. This was assessed by measurement of assessable metastatic deposits by CT, MRI, or direct measure of cutaneous deposits. Baseline tumor measurements used for assessment of clinical response were those obtained most immediately before the first vaccine administration and within 6 weeks of protocol entry. Measurements were made and reviewed by a multidisciplinary team. The original protocol defined tumor response on the basis of changes in cross-sectional area calculated as the product of two perpendicular measures. However, since the initiation of this study, the Response Evaluation Criteria in Solid Tumors Group (RECIST) system was employed as the current standard for clinical trials, in which response is based on changes in maximum cross-sectional dimensions. Computed tomography scans of clinical responders were reviewed again by a senior faculty radiologist not otherwise involved in the study.
Outcome measures
| Measure |
Peptides Pulsed on Dendritic Cells
n=13 Participants
|
Peptides in GMCSF-in-adjuvant
n=13 Participants
|
|---|---|---|
|
Evaluation of Objective Clinical Response (CR/PR/SD)
Complete Response
|
0 participants
|
0 participants
|
|
Evaluation of Objective Clinical Response (CR/PR/SD)
Partial Response
|
1 participants
|
2 participants
|
|
Evaluation of Objective Clinical Response (CR/PR/SD)
Stable Disease
|
1 participants
|
2 participants
|
|
Evaluation of Objective Clinical Response (CR/PR/SD)
Progressive Disease
|
11 participants
|
9 participants
|
PRIMARY outcome
Timeframe: Weeks 0-6,12; Months 6,12 and 24Population: The analysis of this outcome measure was performed on subjects enrolled in Stage I of the trial, which included 13 subjects in each arm. Some patients were not evaluable because of inadequate sample availability.
Outcome measures
| Measure |
Peptides Pulsed on Dendritic Cells
n=9 Participants
|
Peptides in GMCSF-in-adjuvant
n=12 Participants
|
|---|---|---|
|
Measure of Tumor-antigen-specific Immunity in Peripheral Blood Mononuclear Cells (PBMC) by Elispot Assay
|
1 responders
|
5 responders
|
PRIMARY outcome
Timeframe: Weeks 0-6,12; Months 6,12 and 24Population: Analysis of this outcome measure was performed on subjects in Stage I of the trial. Sentinel immunized nodes (SIN) were not evaluable for early tumor progression (5 arm 1, 2 arm 2) and patient refusal (1 arm 2). Thus, SINs were evaluable from 8 in arm 1 and 10 on arm 2, exceeding the protocol requirement for at least 6 subjects on each arm.
Outcome measures
| Measure |
Peptides Pulsed on Dendritic Cells
n=8 Participants
|
Peptides in GMCSF-in-adjuvant
n=10 Participants
|
|---|---|---|
|
Measure of Tumor-antigen-specific Immunity in Sentinel Immunized Node (SIN) by Elispot Assay
|
1 responders
|
8 responders
|
Adverse Events
Peptides Pulsed on Dendritic Cells
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Peptides in GMCSF-in-adjuvant
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peptides Pulsed on Dendritic Cells
n=10 participants at risk
|
Peptides in GMCSF-in-adjuvant
n=27 participants at risk
|
|---|---|---|
|
Hepatobiliary disorders
Alkaline Phosphatase
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
3.7%
1/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Renal and urinary disorders
Creatinine
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
3.7%
1/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
7.4%
2/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
General disorders
Fever
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
3.7%
1/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Cardiac disorders
General- Other
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
3.7%
1/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
3.7%
1/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
3.7%
1/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Endocrine disorders
Other
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
7.4%
2/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
3.7%
1/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
Other adverse events
| Measure |
Peptides Pulsed on Dendritic Cells
n=10 participants at risk
|
Peptides in GMCSF-in-adjuvant
n=27 participants at risk
|
|---|---|---|
|
Hepatobiliary disorders
Alkaline Phosphatase
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
29.6%
8/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Gastrointestinal disorders
Anorexia
|
40.0%
4/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
63.0%
17/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
General disorders
Arthralgia
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
7.4%
2/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Hepatobiliary disorders
Bilirubin
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
7.4%
2/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
7.4%
2/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
22.2%
6/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
4/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
37.0%
10/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Nervous system disorders
Dizziness/Lightheadedness
|
20.0%
2/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
3.7%
1/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
29.6%
8/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Cardiac disorders
Edema
|
10.0%
1/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
22.2%
6/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
11.1%
3/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
General disorders
Fatigue
|
80.0%
8/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
96.3%
26/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
General disorders
Fever
|
40.0%
4/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
63.0%
17/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
20.0%
2/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
22.2%
6/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
General disorders
Headache
|
40.0%
4/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
63.0%
17/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
10.0%
1/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
14.8%
4/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
18.5%
5/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
7.4%
2/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
11.1%
3/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
25.9%
7/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
11.1%
3/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
14.8%
4/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
60.0%
6/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
88.9%
24/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
7.4%
2/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Nervous system disorders
Mood
|
10.0%
1/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
14.8%
4/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
General disorders
Myalgia
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
14.8%
4/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
General disorders
Myalgia/Arthralgia
|
30.0%
3/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
51.9%
14/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
63.0%
17/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Eye disorders
Other
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
7.4%
2/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
General disorders
Other
|
10.0%
1/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
3.7%
1/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
General disorders
Other PAIN
|
20.0%
2/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
22.2%
6/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
5/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
51.9%
14/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
14.8%
4/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
General disorders
Rigors, Chills
|
50.0%
5/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
74.1%
20/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Hepatobiliary disorders
SGOT (AST)
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
7.4%
2/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Hepatobiliary disorders
SGOT/SGPT
|
10.0%
1/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
11.1%
3/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Hepatobiliary disorders
SGPT (ALT)
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
18.5%
5/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Skin and subcutaneous tissue disorders
Skin
|
10.0%
1/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
11.1%
3/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Skin and subcutaneous tissue disorders
Skin Rash/Urticaria
|
40.0%
4/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
14.8%
4/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Gastrointestinal disorders
Stomatitis/Pharyngitis
|
10.0%
1/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
18.5%
5/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
General disorders
Sweating
|
30.0%
3/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
40.7%
11/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes/Stridor/Larynx
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
11.1%
3/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
22.2%
6/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
|
General disorders
Weight Gain/Loss
|
0.00%
0/10 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
7.4%
2/27 • 2 years
Toxicity was recorded with a daily diary of toxicities, reviewed by the research team and supplemented by direct questioning, for the as treated population. Among patients assigned to arm 1, 3 patients progressed rapidly during DC preparation and required other interventions that caused removal from this study before the first vaccine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place