Trial · NCT02444546
Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors
NCT02444546, Phase 1, Completed, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors. Trials, record NCT02444546. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02444546
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors
- NCT number
- NCT02444546
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
Childhood Astrocytoma, Childhood Atypical Teratoid/Rhabdoid Tumor, Diffuse Intrinsic Pontine Glioma, Glioma, Recurrent Childhood Anaplastic Oligodendroglioma, Recurrent Childhood Brain Neoplasm, Recurrent Childhood Glioblastoma, Recurrent Childhood Medulloblastoma, Recurrent Primitive Neuroectodermal Tumor, Refractory Brain Neoplasm
- Interventions
- Laboratory Biomarker Analysis, Sargramostim, Wild-type Reovirus
- First posted
- 2015-05-14
- Last updated
- 2023-04-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MTD, based on the incidence of dose-limiting toxicity (DLT) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 | Up to 84 days | MTD is the highest safely tolerated dose level where 1 of 6 patients experience DLT with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT. |
| Secondary | Adverse event profile | Up to 5 years | The number and severity of adverse events (overall, by dose level, by treatment received) will be tabulated and summarized. The grade 3+ adverse events will also be described and summarized in a similar fashion. |
| Secondary | Objective responses | Up to 5 years | Objective responses will be summarized by descriptive summary statistics delineating complete and partial responses and stable and progressive disease. |
| Secondary | Overall survival | Up to 5 years | Will be summarized descriptively. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and relevant confidence intervals. |
| Secondary | Time to progression | Will be summarized descriptively. | Up to 5 years |
| Secondary | Time to treatment failure | Up to 5 years | Will be summarized descriptively. Time to treatment failure is defined as the time from registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient. |
| Secondary | Time until any treatment-related toxicity | Up to 5 years | Will be summarized descriptively. |
| Secondary | Time until treatment-related grade 3+ toxicity | Up to 5 years | Will be summarized descriptively. |
| Secondary | Toxicity profile, assessed by CTCAE v4.0 | Up to 5 years | Toxicity is defined as adverse events that are classified as possibly, probably, or definitely related to study treatment. Overall toxicity incidence and toxicity profiles by dose level, patient, and treatment will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of the analysis. |
| Other | Immunologic parameters | Up to 5 years | For each of the immunologic parameters, a time series plot will be constructed. A grid reflecting the percent change from pre-treatment levels will be constructed. This grid will be analyzed to determine if the changes seen in each immunologic parameter differ between patients who response and those which do not respond. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
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/NCT02444546
GET https://conductscience.org/api/trials/v1/NCT02444546/registered