Trial · NCT00615927

Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG)

NCT00615927, Phase 2, Completed, Duke University; results first posted 2013-03-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG). Trials, record NCT00615927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00615927

On this page

Trial

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

Title: Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG)
NCT number: NCT00615927
Status: Completed
Phases: Phase 2
Enrollment: 64 participants, actual
Lead sponsor: Duke University
Conditions: Glioblastoma, Gliosarcoma
Interventions: Imatinib Mesylate & Hydroxyurea
First posted: 2008-02-14
Last updated: 2013-03-15
Results first posted: 2013-03-15

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	12-month Progression Free Survival (PFS)	12 months	Percentage of participants surviving twelve months from the start of cycle 1 without progression of disease. PFS was defined as the time from the cycle 1 start date to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.
Secondary	Median Progression-free Survival	Time in weeks from the start of cycle 1 to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 156 weeks	Time in weeks from the start of cycle 1 to the date of first progression according to modified Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
Secondary	Median Overall Survival (OS)	Time in weeks from the start of cycle 1 to date of death due to any cause, assessed up to 156 weeks	Time in weeks from the start of cycle 1 to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Secondary	Objective Response Rate	156 weeks	Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.
Secondary	Safety and Tolerability of Gleevec + Hydroxyurea in Patients With Low-grade Gliomas	156 weeks	The number of patients experiencing any serious adverse event or other (non-serious) adverse event during the study participation.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	12-month Progression Free Survival (PFS)	12 months		percentage of participants	NUMBER
SECONDARY	Median Progression-free Survival	Time in weeks from the start of cycle 1 to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 156 weeks		weeks	MEDIAN
SECONDARY	Median Overall Survival (OS)	Time in weeks from the start of cycle 1 to date of death due to any cause, assessed up to 156 weeks	Median overall survival was not estimable for either arm as not enough events of death occurred	weeks	MEDIAN
SECONDARY	Objective Response Rate	156 weeks		participants	NUMBER
SECONDARY	Safety and Tolerability of Gleevec + Hydroxyurea in Patients With Low-grade Gliomas	156 weeks		participants	NUMBER

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Spread	Units
12-month Progression Free Survival (PFS)	Astrocytoma		43.8	95% Confidence Interval 26.5 to 59.8	percentage of participants
12-month Progression Free Survival (PFS)	Oligodendroglioma		34.4	95% Confidence Interval 18.8 to 50.6	percentage of participants
Median Progression-free Survival	Astrocytoma		43.5	95% Confidence Interval 31.7 to 63.7	weeks
Median Progression-free Survival	Oligodendroglioma		43.3	95% Confidence Interval 24.9 to 53.6	weeks
Median Overall Survival (OS)	Astrocytoma		NA	95% Confidence Interval NA to NA	weeks
Median Overall Survival (OS)	Oligodendroglioma		NA	95% Confidence Interval NA to NA	weeks
Objective Response Rate	Astrocytoma		0		participants
Objective Response Rate	Oligodendroglioma		0		participants
Safety and Tolerability of Gleevec + Hydroxyurea in Patients With Low-grade Gliomas	Astrocytoma	Experienced any Serious Adverse Event	10		participants
Safety and Tolerability of Gleevec + Hydroxyurea in Patients With Low-grade Gliomas	Oligodendroglioma	Experienced any Serious Adverse Event	3		participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Astrocytoma	32
Overall Study	STARTED	Oligodendroglioma	32
Overall Study	COMPLETED	Astrocytoma	32
Overall Study	COMPLETED	Oligodendroglioma	32
Overall Study	NOT COMPLETED	Astrocytoma	0
Overall Study	NOT COMPLETED	Oligodendroglioma	0

Source ClinicalTrials.gov

Adverse events148

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
other	Anemia	Blood and lymphatic system disorders	Astrocytoma	3	32
other	Anemia	Blood and lymphatic system disorders	Oligodendroglioma	2	32
other	Blurred vision	Eye disorders	Astrocytoma	10	32
other	Blurred vision	Eye disorders	Oligodendroglioma	8	32
other	Constipation	Gastrointestinal disorders	Astrocytoma	1	32
other	Constipation	Gastrointestinal disorders	Oligodendroglioma	3	32
other	Diarrhea	Gastrointestinal disorders	Astrocytoma	6	32
other	Diarrhea	Gastrointestinal disorders	Oligodendroglioma	7	32
other	Mucositis oral	Gastrointestinal disorders	Astrocytoma	2	32
other	Mucositis oral	Gastrointestinal disorders	Oligodendroglioma	1	32

1 to 10 of 148Source ClinicalTrials.gov

See all 148 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Astrocytoma
Total, all-cause mortality	Oligodendroglioma
Total, other adverse events	Astrocytoma	28	32
Total, other adverse events	Oligodendroglioma	28	32
Total, serious adverse events	Astrocytoma	10	32
Total, serious adverse events	Oligodendroglioma	3	32

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 comparisons2

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

Comparison	Source
Astrocytoma vs Oligodendroglioma: Objective Response Rate	Trial comparisons
Astrocytoma vs Oligodendroglioma: 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.

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/NCT00615927

GET https://conductscience.org/api/trials/v1/NCT00615927/events?page=2

API reference For AI assistants