Trial · NCT03615404
Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma
NCT03615404, Phase 1, Completed, Gary Archer Ph.D.; results first posted 2021-01-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma. Trials, record NCT03615404. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03615404
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma
- NCT number
- NCT03615404
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 11 participants, actual
- Lead sponsor
- Gary Archer Ph.D.
- Conditions
- Glioblastoma, Malignant Glioma, Medulloblastoma Recurrent, Pediatric Glioblastoma Multiforme, Pediatric Brain Tumor, Recurrent, Pediatric Brain Tumor
- Interventions
- CMV-DCs with GM-CSF, Td (tetanus toxoid)
- First posted
- 2018-08-03
- Last updated
- 2021-01-28
- Results first posted
- 2021-01-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients for Whom 3 or More Vaccines Can be Made | 1 year | Percentage of patients for whom three or more vaccines can be generated from the pre-treatment leukapheresis |
| Primary | Percentage of Patients Who Experience Unacceptable Toxicity | 1 year | Percentage of patients who experience unacceptable toxicity from CMV-DC administration |
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 | Percentage of Patients for Whom 3 or More Vaccines Can be Made | 1 year | percentage of participants | NUMBER | |
| PRIMARY | Percentage of Patients Who Experience Unacceptable Toxicity | 1 year | One eligible patient had a leukapheresis (evaluable for feasibility), but was withdrawn from the study due to clinical decline prior to receiving any treatment (not evaluable for safety). | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients for Whom 3 or More Vaccines Can be Made | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 90.9 | 95% Confidence Interval 58.7 to 99.8 | percentage of participants | |
| Percentage of Patients Who Experience Unacceptable Toxicity | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 0 | percentage of patients |
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 | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 11 | |
| Overall Study | COMPLETED | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 9 | |
| Overall Study | NOT COMPLETED | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 2 |
Source ClinicalTrials.gov
Adverse events44
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 | Anemia | Blood and lymphatic system disorders | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 4 | 9 | |
| other | Sinus tachycardia | Cardiac disorders | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 2 | 9 | |
| other | Eye disorders - Other, specify | Eye disorders | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 1 | 9 | |
| other | Abdominal pain | Gastrointestinal disorders | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 1 | 9 | |
| other | Constipation | Gastrointestinal disorders | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 2 | 9 | |
| other | Diarrhea | Gastrointestinal disorders | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 1 | 9 | |
| other | Hemorrhoids | Gastrointestinal disorders | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 1 | 9 | |
| other | Nausea | Gastrointestinal disorders | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 3 | 9 | |
| other | Vomiting | Gastrointestinal disorders | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 3 | 9 | |
| other | Chills | General disorders | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 1 | 9 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 2 | 9 |
| Total, other adverse events | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 9 | 9 |
| Total, serious adverse events | CMV-DCs With GM-CSF and Td (Tetanus Toxoid) | 0 | 9 |
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/NCT03615404
GET https://conductscience.org/api/trials/v1/NCT03615404/events?page=2