NCT01964300 · STUDY IN CONTEXT

Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

This primary outcome measure only relates to stratum 1 patients.

→

primary · POSTED

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.

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.

→

secondary · POSTED

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.

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.

→

secondary · POSTED

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).

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.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id: NCT01964300
trial label: Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
outcome key
om-0000
source section id
NCT01964300-om-0000
source outcome index
0
endpoint
Rate of Disease Stabilization at 1 Year (i.e., 9 Courses of Treatment) (for Stratum 1 Patients Only)
endpoint definition
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.
time origin
Up to 1 year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
This primary outcome measure only relates to stratum 1 patients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
outcome key
om-0001
source section id
NCT01964300-om-0001
source outcome index
1
endpoint
Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 2 Patients Only)
endpoint definition
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.
time origin
Up to 1 year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
outcome key
om-0002
source section id
NCT01964300-om-0002
source outcome index
2
endpoint
Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 1 Patients Only)
endpoint definition
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.
time origin
Up to 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
outcome key
om-0003
source section id
NCT01964300-om-0003
source outcome index
3
endpoint
Progression-free Survival (PFS)
endpoint definition
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).
time origin
2 years after treatment start
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
outcome key
om-0000
arm key
OG000
arm label
Stratum 1
regimen
Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01964300-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
outcome key
om-0000
arm key
OG001
arm label
Stratum 2
regimen
Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01964300-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
outcome key
om-0001
arm key
OG000
arm label
Stratum 1
regimen
Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01964300-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
outcome key
om-0001
arm key
OG001
arm label
Stratum 2
regimen
Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01964300-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
outcome key
om-0002
arm key
OG000
arm label
Stratum 1
regimen
Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01964300-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
outcome key
om-0002
arm key
OG001
arm label
Stratum 2
regimen
Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01964300-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
outcome key
om-0003
arm key
OG000
arm label
Stratum 1
regimen
Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01964300-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
outcome key
om-0003
arm key
OG001
arm label
Stratum 2
regimen
Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01964300-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
harm key
EG000
source section id
NCT01964300-ae
event group key
EG000
event group label
Stratum 1
serious affected
1
serious at risk
7
other affected
7
other at risk
7
frequency threshold
0
collection period
Up to 2 years after start of treatment
event definition
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. All grades 3 through 5 adverse events while on treatment or within 30 days of treatment were to be collected, in addition to grades 1 and 2 adverse events if the attribution was at least possibly related. All adverse events collected and reported in the study database are reported here.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-craniopharyngioma-pediatric-recurrent-720ccad0
nct id
NCT01964300
harm key
EG001
source section id
NCT01964300-ae
event group key
EG001
event group label
Stratum 2
serious affected
5
serious at risk
12
other affected
12
other at risk
12
frequency threshold
0
collection period
Up to 2 years after start of treatment
event definition
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. All grades 3 through 5 adverse events while on treatment or within 30 days of treatment were to be collected, in addition to grades 1 and 2 adverse events if the attribution was at least possibly related. All adverse events collected and reported in the study database are reported here.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice