Trial · NCT01964300
Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
NCT01964300, Phase 2, Terminated, Pediatric Brain Tumor Consortium; results first posted 2020-02-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery. Trials, record NCT01964300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01964300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
- NCT number
- NCT01964300
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Pediatric Brain Tumor Consortium
- Conditions
- Childhood Craniopharyngioma
- Interventions
- peginterferon alfa-2b, laboratory biomarker analysis
- First posted
- 2013-10-17
- Last updated
- 2020-02-24
- Results first posted
- 2020-02-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Disease Stabilization at 1 Year (i.e., 9 Courses of Treatment) (for Stratum 1 Patients Only) | Up to 1 year | The percentage of stratum 1 patients with disease stabilization at 1 year is reported, along with a 95% exact confidence interval for the estimate of the true 1-year disease stabilization rate. |
| Primary | Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 2 Patients Only) | Up to 1 year | Objective responses had to be sustained for 3 months. The percentage of participants with sustained objective responses is reported with an exact 95% confidence interval of the true sustained objective response rate. |
| Secondary | Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 1 Patients Only) | Up to 1 year | Objective responses had to be sustained for 3 months. The percentage of participants with sustained objective responses is reported with an exact 95% confidence interval of the true sustained objective response rate. |
| Secondary | Progression-free Survival (PFS) | 2 years after treatment start | PFS estimates for each stratum were estimated using the method of Kaplan and Meier. PFS was defined as the time interval from date on treatment to the earliest date of disease progression, second malignancy, or death; or to date of last contact for patients without events. One- and two-year PFS estimates are reported by stratum. Only eligible patients were included in this analysis (7 stratum 1 patients and 11 stratum 2 patients). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Disease Stabilization at 1 Year (i.e., 9 Courses of Treatment) (for Stratum 1 Patients Only) | Up to 1 year | This primary outcome measure only relates to stratum 1 patients. | percentage of participants | NUMBER |
| PRIMARY | Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 2 Patients Only) | Up to 1 year | Only eligible stratum 2 patients are included in this analysis. This is a \*secondary\* outcome measure for stratum 1 patients and is therefore reported as a separate outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 1 Patients Only) | Up to 1 year | The seven stratum 1 patients are included in this analysis. This outcome measure was a \*primary\* outcome measure for stratum 2 patients and is therefore reported as a separate outcome measure for stratum 2. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | 2 years after treatment start | The one ineligible stratum 2 patient enrolled on the study was excluded from this analysis, leaving 7 stratum 1 patients and 11 stratum 2 patients. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Disease Stabilization at 1 Year (i.e., 9 Courses of Treatment) (for Stratum 1 Patients Only) | Stratum 1 | 28.6 | 95% Confidence Interval 5.3 to 65.9 | percentage of participants | |
| Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 2 Patients Only) | Stratum 2 | 0.0 | 95% Confidence Interval 0.0 to 25.0 | percentage of participants | |
| Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 1 Patients Only) | Stratum 1 | 14.3 | 95% Confidence Interval 0.01 to 55.4 | percentage of participants | |
| Progression-free Survival (PFS) | Stratum 1 | PFS at 1 year | 83.3 | 95% Confidence Interval 50.0 to 100.0 | percentage of participants |
| Progression-free Survival (PFS) | Stratum 2 | PFS at 1 year | 68.2 | 95% Confidence Interval 39.8 to 96.6 | percentage of participants |
| Progression-free Survival (PFS) | Stratum 1 | PFS at 2 years | 27.8 | 95% Confidence Interval 0.0 to 60.5 | percentage of participants |
| Progression-free Survival (PFS) | Stratum 2 | PFS at 2 years | 34.1 | 95% Confidence Interval 0.0 to 72.5 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum 1 | 7 | |
| Overall Study | STARTED | Stratum 2 | 12 | |
| Overall Study | COMPLETED | Stratum 1 | 1 | |
| Overall Study | COMPLETED | Stratum 2 | 1 | |
| Overall Study | NOT COMPLETED | Stratum 1 | 6 | |
| Overall Study | NOT COMPLETED | Stratum 2 | 11 |
Source ClinicalTrials.gov
Adverse events156
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 | Stratum 1 | 3 | 7 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Stratum 2 | 3 | 12 | 4 |
| other | Blurred vision | Eye disorders | Stratum 1 | 0 | 7 | 0 |
| other | Blurred vision | Eye disorders | Stratum 2 | 1 | 12 | 1 |
| other | Floaters | Eye disorders | Stratum 1 | 0 | 7 | 0 |
| other | Floaters | Eye disorders | Stratum 2 | 1 | 12 | 1 |
| other | Optic nerve disorder | Eye disorders | Stratum 1 | 0 | 7 | 0 |
| other | Optic nerve disorder | Eye disorders | Stratum 2 | 1 | 12 | 1 |
| other | Photophobia | Eye disorders | Stratum 1 | 0 | 7 | 0 |
| other | Photophobia | Eye disorders | Stratum 2 | 1 | 12 | 1 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum 1 | 0 | 7 |
| Total, all-cause mortality | Stratum 2 | 1 | 12 |
| Total, other adverse events | Stratum 1 | 7 | 7 |
| Total, other adverse events | Stratum 2 | 12 | 12 |
| Total, serious adverse events | Stratum 1 | 1 | 7 |
| Total, serious adverse events | Stratum 2 | 5 | 12 |
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 |
|---|---|---|---|---|---|
| U01CA081457 | Pediatric Brain Tumor Consortium (PBTC) | BOYETT, JAMES MILFORD | ST. JUDE CHILDREN'S RESEARCH HOSPITAL | NATIONAL CANCER INSTITUTE | 1999 to 2013 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Stratum 1 vs Stratum 2: deaths from any cause | Trial comparisons |
| Stratum 1 vs Stratum 2: serious adverse events | Trial comparisons |
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/NCT01964300
GET https://conductscience.org/api/trials/v1/NCT01964300/events?page=2