Trial · NCT01042366
Dendritic Cells (DC) Vaccine for Metastatic Melanoma
NCT01042366, Phase 2, Terminated, John Kirkwood; results first posted 2017-08-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dendritic Cells (DC) Vaccine for Metastatic Melanoma. Trials, record NCT01042366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01042366
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dendritic Cells (DC) Vaccine for Metastatic Melanoma
- NCT number
- NCT01042366
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- John Kirkwood
- Conditions
- Metastatic Melanoma
- Interventions
- Vaccination
- First posted
- 2010-01-05
- Last updated
- 2017-08-16
- Results first posted
- 2017-08-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Delayed Type Hypersensitivity (DTH) Response | 12 mo | Delayed type hypersensitivity (DTH) response to antigen-loaded autologous, dendritic cell vaccine (DC) injected intradermal in vivo |
| Primary | ELISpot Response to Melanoma | 12 mo | Peripheral blood CD8+ and CD4+ T cell responses against autologous tumor cells, and HLA-presented melanoma epitopes, using ELISPOT and MHC-peptide tetramer assays. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Delayed Type Hypersensitivity (DTH) Response | 12 mo | Patients who met inclusion criteria and received at least 3 doses of the vaccine | participants | NUMBER |
| PRIMARY | ELISpot Response to Melanoma | 12 mo | Patients who met inclusion criteria and received at least 3 doses of the vaccine | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Delayed Type Hypersensitivity (DTH) Response | DCs Co-cultured With Melanoma Cells | 2 | participants | ||
| Delayed Type Hypersensitivity (DTH) Response | DCs Pulsed With Tumor Cell Lysates | 2 | participants | ||
| Delayed Type Hypersensitivity (DTH) Response | DCs Fused With Tumor Cells | 1 | participants | ||
| ELISpot Response to Melanoma | DCs Co-cultured With Melanoma Cells | 2 | participants | ||
| ELISpot Response to Melanoma | DCs Pulsed With Tumor Cell Lysates | 2 | participants | ||
| ELISpot Response to Melanoma | DCs Fused With Tumor Cells | 1 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DCs Co-cultured With Melanoma Cells | 5 | |
| Overall Study | STARTED | DCs Pulsed With Tumor Cell Lysates | 6 | |
| Overall Study | STARTED | DCs Fused With Tumor Cells | 4 | |
| Overall Study | COMPLETED | DCs Co-cultured With Melanoma Cells | 5 | |
| Overall Study | COMPLETED | DCs Pulsed With Tumor Cell Lysates | 6 | |
| Overall Study | COMPLETED | DCs Fused With Tumor Cells | 4 | |
| Overall Study | NOT COMPLETED | DCs Co-cultured With Melanoma Cells | 0 | |
| Overall Study | NOT COMPLETED | DCs Pulsed With Tumor Cell Lysates | 0 | |
| Overall Study | NOT COMPLETED | DCs Fused With Tumor Cells | 0 |
Source ClinicalTrials.gov
Adverse events37
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemoglobin | Blood and lymphatic system disorders | All Participants (Overall Study) | 4 | 15 | |
| other | Platelets | Investigations | All Participants (Overall Study) | 1 | 15 | |
| other | Edema | General disorders | All Participants (Overall Study) | 1 | 15 | |
| other | Fatigue (lethargy, malaise, asthenia) | General disorders | All Participants (Overall Study) | 4 | 15 | |
| other | Constitutional Symptoms-Other | General disorders | All Participants (Overall Study) | 3 | 15 | |
| other | Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) | General disorders | All Participants (Overall Study) | 1 | 15 | |
| other | Flushing | Vascular disorders | All Participants (Overall Study) | 1 | 15 | |
| other | Injection site reaction | General disorders | All Participants (Overall Study) | 5 | 15 | |
| other | Dermatology/Skin-Other | Skin and subcutaneous tissue disorders | All Participants (Overall Study) | 1 | 15 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | All Participants (Overall Study) | 1 | 15 |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants (Overall Study) | ||
| Total, other adverse events | All Participants (Overall Study) | 11 | 15 |
| Total, serious adverse events | All Participants (Overall Study) | 1 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P01CA073743 | Dendritic Cell Biology and Therapy | FINN, OLIVERA J | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL CANCER INSTITUTE | 1998 to 2009 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01042366
GET https://conductscience.org/api/trials/v1/NCT01042366/events?page=2