Trial · NCT00458536
Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF
NCT00458536, Phase 1, Phase 2, Completed, Beth Israel Deaconess Medical Center; results first posted 2016-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF. Trials, record NCT00458536. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00458536
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF
- NCT number
- NCT00458536
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Renal Cancer
- Interventions
- Dendritic Cell Tumor Fusion Vaccine, Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
- First posted
- 2007-04-11
- Last updated
- 2026-07-29
- Results first posted
- 2016-02-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF | 6 months following last dose of treatment, up to 9 months | |
| Secondary | Number of Participants Who Demonstrated a Two-fold Increase in Interferon Gamma | Pre-vaccine and 6 months post vaccine | Interferon gamma levels were assessed to determine if cellular and humoral immunity is induced by serial vaccination with DC/tumor fusion cells and GM-CSF. This is a way to measure immunologic response following vaccination. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF | 5 years | Adverse events potentially related to vaccination were largely restricted to injection site reactions. 12 of the 19 patients experienced vaccine site reactions. | participants | NUMBER |
| SECONDARY | To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and GM-CSF | 5 years | |||
| SECONDARY | to Correlate Immunologic Response Following Vaccination. | 5 years |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF | Patients Treated With Vaccine | 12 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients Treated With Vaccine | 38 | |
| Overall Study | COMPLETED | Patients Treated With Vaccine | 19 | |
| Overall Study | NOT COMPLETED | Patients Treated With Vaccine | 19 |
Source ClinicalTrials.gov
Adverse events4
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 | Injection Site Reaction | Investigations | Patients Treated With Vaccine | 12 | 19 | 25 |
| other | Bruising (at site of vaccine) | Blood and lymphatic system disorders | Patients Treated With Vaccine | 3 | 19 | 7 |
| other | Arthralgias | Musculoskeletal and connective tissue disorders | Patients Treated With Vaccine | 1 | 19 | 2 |
| other | Urticaria | Investigations | Patients Treated With Vaccine | 1 | 19 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients Treated With Vaccine | ||
| Total, other adverse events | Patients Treated With Vaccine | 16 | 19 |
| Total, serious adverse events | Patients Treated With Vaccine | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT00458536
GET https://conductscience.org/api/trials/v1/NCT00458536/registered