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Trial · NCT00047879

Phase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas

NCT00047879, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2011-10-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Phase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas. Trials, record NCT00047879. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00047879

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Phase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas
NCT number
NCT00047879
Status
Completed
Phases
Phase 2
Enrollment
7 participants, actual
Lead sponsor
National Cancer Institute (NCI)
Conditions
Glioma
Interventions
PEG-interferon alfa-2b, Thalidomide
First posted
2002-10-23
Last updated
2011-10-26
Results first posted
2011-10-26
Limitations and caveats
Registered 7 out of 64 participants and they came off study for progressive disease around 3-4 months after starting the study.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProgression-free Survival6 months
Progression free survival is defined as the percent of patients that are progression free and alive 6 months after initiating therapy. Progression of disease by \> 50% increase in the size of the tumor compared to baseline after the first cycle only, and then \>25% increase in the size of the tumor for all subsequent cycles.
SecondaryNumber of Participants With Complete or Partial Response6 months
Response is defined per RECIST criteria. Measurable disease is defined as bidimensionally measurable lesions with clearly defined margins by CT or MRI scan. Evaluable disease is defined as unidimensionally measurable lesions, masses with margins not clearly defined, or lesions with a multiple cystic component. Complete response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products or perpendicular diameters of all measurable lesions.
SecondaryThe Number of Participants With Adverse Events4 monthsHere are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProgression-free Survival6 months
The primary objective was not met. Only registered 7 out of 64 participants and they all came off the study for progressive disease around 3-4 months after starting the study. None of the participants were evaluated for progression-free survival at 6 months because the study was stopped at 4 months due to progressive disease.
Percent of participantsNUMBER
SECONDARYNumber of Participants With Complete or Partial Response6 monthsRegistered 7 out of 64 participants and they came off study for progressive disease around 3-4 months after starting the study.ParticipantsNUMBER
SECONDARYThe Number of Participants With Adverse Events4 monthsParticipantsNUMBER

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
The Number of Participants With Adverse EventsGlioblastoma Multiforme Stratum4Participants
The Number of Participants With Adverse EventsAnaplastic Glioma Stratum2Participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDGlioblastoma Multiforme Stratum4
Overall StudySTARTEDAnaplastic Glioma Stratum3
Overall StudyCOMPLETEDGlioblastoma Multiforme Stratum0
Overall StudyCOMPLETEDAnaplastic Glioma Stratum0
Overall StudyNOT COMPLETEDGlioblastoma Multiforme Stratum4
Overall StudyNOT COMPLETEDAnaplastic Glioma Stratum3

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otheredema: limb right upper extremityGeneral disordersGlioblastoma Multiforme Stratum040
otheredema: limb right upper extremityGeneral disordersAnaplastic Glioma Stratum131
otherThrombocytopeniaInvestigationsGlioblastoma Multiforme Stratum040
otherThrombocytopeniaInvestigationsAnaplastic Glioma Stratum131
otherFatigueGeneral disordersGlioblastoma Multiforme Stratum243
otherFatigueGeneral disordersAnaplastic Glioma Stratum030
otherDizzinessNervous system disordersGlioblastoma Multiforme Stratum141
otherDizzinessNervous system disordersAnaplastic Glioma Stratum030
otherInfectionInfections and infestationsGlioblastoma Multiforme Stratum141
otherInfectionInfections and infestationsAnaplastic Glioma Stratum030

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityGlioblastoma Multiforme Stratum
Total, all-cause mortalityAnaplastic Glioma Stratum
Total, other adverse eventsGlioblastoma Multiforme Stratum44
Total, other adverse eventsAnaplastic Glioma Stratum23
Total, serious adverse eventsGlioblastoma Multiforme Stratum34
Total, serious adverse eventsAnaplastic Glioma Stratum23

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
8315428BACKGROUNDPubMed
8433151BACKGROUNDPubMed
10673511BACKGROUNDPubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Glioblastoma Multiforme Stratum vs Anaplastic Glioma Stratum: The Number of Participants With Adverse EventsTrial comparisons
Glioblastoma Multiforme Stratum vs Anaplastic Glioma Stratum: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT00047879

GET https://conductscience.org/api/trials/v1/NCT00047879/events?page=2