Trial · NCT00396019
Study of PEG-Intron for Plexiform Neurofibromas
NCT00396019, Phase 2, Completed, University of Pittsburgh; results first posted 2017-11-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of PEG-Intron for Plexiform Neurofibromas. Trials, record NCT00396019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00396019
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of PEG-Intron for Plexiform Neurofibromas
- NCT number
- NCT00396019
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 86 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Plexiform Neurofibroma
- Interventions
- PEG-Intron
- First posted
- 2006-11-06
- Last updated
- 2017-11-06
- Results first posted
- 2017-11-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Imaging Response in Strata 1 and 2 | MRI scans were performed at baseline and at months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study. | A response was defined as a ≥20% reduction in the sum of the volume of the "target" plexiform neurofibroma ( PN) within 12 months confirmed by a follow-up MRI after ≥4 weeks. |
| Primary | Clinical Response in Stratum 2 | baseline, week 6, months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study | Clinical response was defined as a protocol-specified improvement in ophthalmologic evaluation, an improvement of at least one level in performance status (PS) ≥50% decrease in the amount of pain medications required per week compared with baseline or ability to change from a narcotic to a nonnarcotic analgesic, sustained for at least one month. |
| Primary | Time to Progression (TTP) in Stratum 3 | baseline, week 6, months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study | TTP was estimated by the Kaplan-Meter method |
| Secondary | Number of Participants With Imaging Response in Stratum 3 | MRI scans were performed at baseline and at months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study | A Response was defined as a ≥ 20% reduction in the sum of the volume of the "target" plexiform neurofibroma (PN) within 12 months, confirmed by a follow-up MRI after ≥ 24 weeks |
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 | Number of Participants With Imaging Response in Strata 1 and 2 | MRI scans were performed at baseline and at months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study. | participants | NUMBER | |
| PRIMARY | Clinical Response in Stratum 2 | baseline, week 6, months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study | Only participants in Stratum 2 contributed data for this Outcome Measure | participants | NUMBER |
| PRIMARY | Time to Progression (TTP) in Stratum 3 | baseline, week 6, months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study | Only participants in Stratum 3 contributed data for this Outcome Measure | months | MEDIAN |
| SECONDARY | Number of Participants With Imaging Response in Stratum 3 | MRI scans were performed at baseline and at months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Imaging Response in Strata 1 and 2 | Stratum 1 No Symptom With or Withour Tumor Growth | Confirmed Response | 0 | participants | |
| Number of Participants With Imaging Response in Strata 1 and 2 | Stratum 2 Symptoms no Tumor Growth | Confirmed Response | 1 | participants | |
| Number of Participants With Imaging Response in Strata 1 and 2 | Stratum 1 No Symptom With or Withour Tumor Growth | Unconfirmed Response | 1 | participants | |
| Number of Participants With Imaging Response in Strata 1 and 2 | Stratum 2 Symptoms no Tumor Growth | Unconfirmed Response | 0 | participants | |
| Clinical Response in Stratum 2 | Stratum 2 Symptoms on Tumor Growth | 3 | participants | ||
| Time to Progression (TTP) in Stratum 3 | Stratum 3: Tumor Growth With or Without Symptoms | 29.4 | Full Range 7.1 to NA | months | |
| Number of Participants With Imaging Response in Stratum 3 | Stratum 3: Tumor Growth With or Without Symptoms | Confirmed Response | 1 | participants | |
| Number of Participants With Imaging Response in Stratum 3 | Stratum 3: Tumor Growth With or Without Symptoms | Unconfirmed Response | 1 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum 1 No Symptom With or Withour Tumor Growth | 27 | |
| Overall Study | STARTED | Stratum 2 Symptoms no Tumor Growth | 29 | |
| Overall Study | STARTED | Stratum 3 Tumor Growth With or Without Symptoms | 30 | |
| Overall Study | COMPLETED | Stratum 1 No Symptom With or Withour Tumor Growth | 27 | |
| Overall Study | COMPLETED | Stratum 2 Symptoms no Tumor Growth | 26 | |
| Overall Study | COMPLETED | Stratum 3 Tumor Growth With or Without Symptoms | 29 | |
| Overall Study | NOT COMPLETED | Stratum 1 No Symptom With or Withour Tumor Growth | 0 | |
| Overall Study | NOT COMPLETED | Stratum 2 Symptoms no Tumor Growth | 3 | |
| Overall Study | NOT COMPLETED | Stratum 3 Tumor Growth With or Without Symptoms | 1 |
Source ClinicalTrials.gov
Adverse events15
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 | Fatigue | General disorders | Stratum 1 No Symptom With or Withour Tumor Growth | 2 | 27 | |
| other | Fatigue | General disorders | Stratum 2 Symptoms no Tumor Growth | 4 | 26 | |
| other | Fatigue | General disorders | Stratum 3 Tumor Growth With or Without Symptoms | 2 | 29 | |
| other | Behavior | Psychiatric disorders | Stratum 1 No Symptom With or Withour Tumor Growth | 2 | 27 | |
| other | Behavior | Psychiatric disorders | Stratum 2 Symptoms no Tumor Growth | 3 | 26 | |
| other | Behavior | Psychiatric disorders | Stratum 3 Tumor Growth With or Without Symptoms | 2 | 29 | |
| other | Allergic Reaction | General disorders | Stratum 1 No Symptom With or Withour Tumor Growth | 1 | 27 | |
| other | Allergic Reaction | General disorders | Stratum 2 Symptoms no Tumor Growth | 0 | 26 | |
| other | Allergic Reaction | General disorders | Stratum 3 Tumor Growth With or Without Symptoms | 0 | 29 | |
| other | Depression | Psychiatric disorders | Stratum 1 No Symptom With or Withour Tumor Growth | 2 | 27 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum 1 No Symptom With or Withour Tumor Growth | 0 | 27 |
| Total, all-cause mortality | Stratum 2 Symptoms no Tumor Growth | 0 | 26 |
| Total, all-cause mortality | Stratum 3 Tumor Growth With or Without Symptoms | 0 | 29 |
| Total, other adverse events | Stratum 1 No Symptom With or Withour Tumor Growth | 7 | 27 |
| Total, other adverse events | Stratum 2 Symptoms no Tumor Growth | 8 | 26 |
| Total, other adverse events | Stratum 3 Tumor Growth With or Without Symptoms | 6 | 29 |
| Total, serious adverse events | Stratum 1 No Symptom With or Withour Tumor Growth | 0 | 27 |
| Total, serious adverse events | Stratum 2 Symptoms no Tumor Growth | 0 | 26 |
| Total, serious adverse events | Stratum 3 Tumor Growth With or Without Symptoms | 0 | 29 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27510726 | RESULT |
Source PubMed
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/NCT00396019
GET https://conductscience.org/api/trials/v1/NCT00396019/registered