Trial · NCT01188096
A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas
NCT01188096, Phase 2, Completed, Wake Forest University Health Sciences; results first posted 2023-04-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas. Trials, record NCT01188096. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01188096
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas
- NCT number
- NCT01188096
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Brain Tumors
- Interventions
- Poly ICLC
- First posted
- 2010-08-25
- Last updated
- 2023-06-12
- Results first posted
- 2023-04-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | 6 months | Percentage with no progression of disease by MRI 3D Macdonald criteria. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Overall Response Rate | at 6 months following start treatment with study drug | Tumor assessments are to be performed per Modified McDonald's criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar criteria for the Modified Mcdonald's Criteria, as accurate and appropriate. |
| Secondary | Overall Response Rate | at 2 years after start of treatment with study drug | Tumor assessments are to be performed per 3D measurements. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar criteria for the Modified Mcdonald's Criteria, as accurate and appropriate. |
| Secondary | Overall Survival Rate | month 6, 24 months | |
| Other | Toxicity Associated With Treatment With Poly-ICLC | month 6, 24 months | in pediatric patients with recurrent low grade gliomas |
| Other | The Effect of Treatment With Poly-ICLC on the Signaling Pathways Controlling Apoptosis in Low Grade Glioma Tumor Cells. | month 6, 24 months | |
| Other | Surrogate Markers of Tumor Response and Progression Can be Identified in the Serum | month 6, 24 months | See if markers can be identified in the serum of patients with recurrent low grade gliomas treated with poly-ICLC. |
| Other | Surrogate Markers of Tumor Response and Progression Peripheral Blood Mononuclear Cells (PBMC) | month 6, 24 months | Look for presence of markers in PBMC and/or cerebrospinal fluid of patients with recurrent low grade gliomas treated with poly-ICLC. |
| Other | Surrogate Markers of Tumor Response and Progression--Cerebrospinal Fluid | month 6, 24 months | Look for presence of markers in cerebrospinal fluid of patients with recurrent low grade gliomas treated with poly-ICLC. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival | 6 months | percentage of no progression | NUMBER | |
| SECONDARY | Overall Response Rate | at 6 months following start treatment with study drug | percentage of response | NUMBER | |
| SECONDARY | Overall Response Rate | at 2 years after start of treatment with study drug | percentage of response | NUMBER | |
| SECONDARY | Overall Survival Rate | month 6, 24 months | percentage of survival | NUMBER | |
| OTHER_PRE_SPECIFIED | Toxicity Associated With Treatment With Poly-ICLC | month 6, 24 months | collected during the study as AEs/SAEs and is reflected this way in the record | ||
| OTHER_PRE_SPECIFIED | The Effect of Treatment With Poly-ICLC on the Signaling Pathways Controlling Apoptosis in Low Grade Glioma Tumor Cells. | month 6, 24 months | Outcome data was not collected and in the course of the study the outcome was not considered primary or secondary. | ||
| OTHER_PRE_SPECIFIED | Surrogate Markers of Tumor Response and Progression Can be Identified in the Serum | month 6, 24 months | Outcome data was not collected; and in the course of the study the outcome was not considered primary or secondary | ||
| OTHER_PRE_SPECIFIED | Surrogate Markers of Tumor Response and Progression Peripheral Blood Mononuclear Cells (PBMC) | month 6, 24 months | Outcome data was not collected; and in the course of the study the outcome was not considered primary or secondary | ||
| OTHER_PRE_SPECIFIED | Surrogate Markers of Tumor Response and Progression--Cerebrospinal Fluid | month 6, 24 months | Outcome data was not collected; and in the course of the study the outcome was not considered primary or secondary |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival | Poly ICLC | 70 | percentage of no progression | ||
| Overall Response Rate | Poly ICLC | 74 | percentage of response | ||
| Overall Response Rate | Poly ICLC | 8.6 | percentage of response | ||
| Overall Survival Rate | Poly ICLC | Month 6 | 100 | percentage of survival | |
| Overall Survival Rate | Poly ICLC | Year 2 | 100 | percentage of survival |
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 | Poly ICLC | 23 | |
| Overall Study | COMPLETED | Poly ICLC | 17 | |
| Overall Study | NOT COMPLETED | Poly ICLC | 6 |
Source ClinicalTrials.gov
Adverse events89
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 | Anorexia | Gastrointestinal disorders | Poly ICLC | 1 | 23 | 1 |
| other | Anxiety | Psychiatric disorders | Poly ICLC | 1 | 23 | 1 |
| other | Bronchial Infection | Respiratory, thoracic and mediastinal disorders | Poly ICLC | 1 | 23 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Poly ICLC | 2 | 23 | 2 |
| other | aspartate transferase (AST) Increase | Blood and lymphatic system disorders | Poly ICLC | 6 | 23 | 10 |
| other | Alanine transaminase (ALT) Increase | Blood and lymphatic system disorders | Poly ICLC | 10 | 23 | 23 |
| other | blood urea nitrogen (BUN) Increase | Blood and lymphatic system disorders | Poly ICLC | 1 | 23 | 1 |
| other | Bilirubin Increase | Blood and lymphatic system disorders | Poly ICLC | 1 | 23 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Poly ICLC | 4 | 23 | 10 |
| other | Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Poly ICLC | 1 | 23 | 1 |
1 to 10 of 89Source ClinicalTrials.gov
See all 89 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Poly ICLC | 0 | 23 |
| Total, other adverse events | Poly ICLC | 22 | 23 |
| Total, serious adverse events | Poly ICLC | 5 | 23 |
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/NCT01188096
GET https://conductscience.org/api/trials/v1/NCT01188096/events?page=2