Trial Outcomes & Findings for Dendritic Cells (DC) Vaccine for Metastatic Melanoma (NCT NCT01042366)
NCT ID: NCT01042366
Last Updated: 2017-08-16
Results Overview
Delayed type hypersensitivity (DTH) response to antigen-loaded autologous, dendritic cell vaccine (DC) injected intradermal in vivo
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
12 mo
Results posted on
2017-08-16
Participant Flow
Although 16 subjects were enrolled, one subject was referred to hospice and never began the study.
Participant milestones
| Measure |
DCs Co-cultured With Melanoma Cells
DCs co-cultured with melanoma cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
|
DCs Pulsed With Tumor Cell Lysates
DCs pulsed with tumor cell lysates
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
|
DCs Fused With Tumor Cells
DCs fused with tumor cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
4
|
|
Overall Study
COMPLETED
|
5
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dendritic Cells (DC) Vaccine for Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
DCs Co-cultured With Melanoma Cells
n=5 Participants
DCs co-cultured with melanoma cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
|
DCs Pulsed With Tumor Cell Lysates
n=6 Participants
DCs pulsed with tumor cell lysates
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
|
DCs Fused With Tumor Cells
n=4 Participants
DCs fused with tumor cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
44.5 years
n=7 Participants
|
54 years
n=5 Participants
|
49 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 moPopulation: Patients who met inclusion criteria and received at least 3 doses of the vaccine
Delayed type hypersensitivity (DTH) response to antigen-loaded autologous, dendritic cell vaccine (DC) injected intradermal in vivo
Outcome measures
| Measure |
DCs Co-cultured With Melanoma Cells
n=5 Participants
DCs co-cultured with melanoma cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
|
DCs Pulsed With Tumor Cell Lysates
n=6 Participants
DCs pulsed with tumor cell lysates
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
|
DCs Fused With Tumor Cells
n=4 Participants
DCs fused with tumor cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
|
|---|---|---|---|
|
Delayed Type Hypersensitivity (DTH) Response
|
2 participants
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 12 moPopulation: Patients who met inclusion criteria and received at least 3 doses of the vaccine
Peripheral blood CD8+ and CD4+ T cell responses against autologous tumor cells, and HLA-presented melanoma epitopes, using ELISPOT and MHC-peptide tetramer assays.
Outcome measures
| Measure |
DCs Co-cultured With Melanoma Cells
n=5 Participants
DCs co-cultured with melanoma cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
|
DCs Pulsed With Tumor Cell Lysates
n=6 Participants
DCs pulsed with tumor cell lysates
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
|
DCs Fused With Tumor Cells
n=4 Participants
DCs fused with tumor cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
|
|---|---|---|---|
|
ELISpot Response to Melanoma
|
2 participants
|
2 participants
|
1 participants
|
Adverse Events
All Participants (Overall Study)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants (Overall Study)
n=15 participants at risk
For all arms: DC vaccine Co-cultured With Melanoma Cells; DC Vaccine Pulsed With Tumor Cell Lysates; DC Vaccines Fused With Tumor Cells
|
|---|---|
|
Hepatobiliary disorders
Hepatic-Other
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
Other adverse events
| Measure |
All Participants (Overall Study)
n=15 participants at risk
For all arms: DC vaccine Co-cultured With Melanoma Cells; DC Vaccine Pulsed With Tumor Cell Lysates; DC Vaccines Fused With Tumor Cells
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
26.7%
4/15
Adverse events were not collected/monitored per Arm/Group
|
|
Investigations
Platelets
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
General disorders
Edema
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
26.7%
4/15
Adverse events were not collected/monitored per Arm/Group
|
|
General disorders
Constitutional Symptoms-Other
|
20.0%
3/15
Adverse events were not collected/monitored per Arm/Group
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Vascular disorders
Flushing
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
General disorders
Injection site reaction
|
33.3%
5/15
Adverse events were not collected/monitored per Arm/Group
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
13.3%
2/15
Adverse events were not collected/monitored per Arm/Group
|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15
Adverse events were not collected/monitored per Arm/Group
|
|
Gastrointestinal disorders
Taste disturbance (dysgeusia)
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Investigations
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Hepatobiliary disorders
Hepatic-Other
|
13.3%
2/15
Adverse events were not collected/monitored per Arm/Group
|
|
Investigations
Alkaline phosphatase
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Blood and lymphatic system disorders
Lymphatics-Other
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal-Other
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Nervous system disorders
Neurology-Other
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15
Adverse events were not collected/monitored per Arm/Group
|
|
Nervous system disorders
Dizziness/lightheadedness
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Psychiatric disorders
Mood alteration-anxiety, agitation
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Nervous system disorders
Headache
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Nervous system disorders
Neuropathic pain
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Psychiatric disorders
Mood alteration-depression
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
Nervous system disorders
Neuropathy-sensory
|
20.0%
3/15
Adverse events were not collected/monitored per Arm/Group
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain (onset or exacerbation of tumor pain due to treatment)
|
6.7%
1/15
Adverse events were not collected/monitored per Arm/Group
|
|
General disorders
Pain-Other
|
20.0%
3/15
Adverse events were not collected/monitored per Arm/Group
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
3/15
Adverse events were not collected/monitored per Arm/Group
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
13.3%
2/15
Adverse events were not collected/monitored per Arm/Group
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place