Trial Outcomes & Findings for Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG) (NCT NCT00615927)

Last Updated: 2013-03-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

12 months

Results posted on

2013-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Astrocytoma Grade II Astrocytoma	Oligodendroglioma Grade II Oligodendroglioma or oligoastrocytomas
Overall Study STARTED	32	32
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Astrocytoma n=32 Participants Grade II Astrocytoma	Oligodendroglioma n=32 Participants Grade II Oligodendroglioma or oligoastrocytomas	Total n=64 Participants Total of all reporting groups
Age Continuous	42.6 years STANDARD_DEVIATION 16.6 • n=5 Participants	46.6 years STANDARD_DEVIATION 11.8 • n=7 Participants	44.6 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Astrocytoma n=32 Participants Grade II Astrocytoma	Oligodendroglioma n=32 Participants Grade II Oligodendroglioma or oligoastrocytomas
12-month Progression Free Survival (PFS)	43.8 percentage of participants Interval 26.5 to 59.8	34.4 percentage of participants Interval 18.8 to 50.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Astrocytoma n=32 Participants Grade II Astrocytoma	Oligodendroglioma n=32 Participants Grade II Oligodendroglioma or oligoastrocytomas
Median Progression-free Survival	43.5 weeks Interval 31.7 to 63.7	43.3 weeks Interval 24.9 to 53.6

SECONDARY outcome

Timeframe: Time in weeks from the start of cycle 1 to date of death due to any cause, assessed up to 156 weeks

Population: Median overall survival was not estimable for either arm as not enough events of death occurred

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.

Outcome measures

Outcome measures
Measure	Astrocytoma n=32 Participants Grade II Astrocytoma	Oligodendroglioma n=32 Participants Grade II Oligodendroglioma or oligoastrocytomas
Median Overall Survival (OS)	NA weeks Median overall survival was not estimable for either arm as not enough events of death occurred.	NA weeks Median overall survival was not estimable for either arm as not enough events of death occurred.

SECONDARY outcome

Timeframe: 156 weeks

Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.

Outcome measures

Outcome measures
Measure	Astrocytoma n=32 Participants Grade II Astrocytoma	Oligodendroglioma n=32 Participants Grade II Oligodendroglioma or oligoastrocytomas
Objective Response Rate	0 participants	0 participants

SECONDARY outcome

Timeframe: 156 weeks

The number of patients experiencing any serious adverse event or other (non-serious) adverse event during the study participation.

Outcome measures

Outcome measures
Measure	Astrocytoma n=32 Participants Grade II Astrocytoma	Oligodendroglioma n=32 Participants Grade II Oligodendroglioma or oligoastrocytomas
Safety and Tolerability of Gleevec + Hydroxyurea in Patients With Low-grade Gliomas Experienced any Serious Adverse Event	10 participants	3 participants
Safety and Tolerability of Gleevec + Hydroxyurea in Patients With Low-grade Gliomas Experienced any (non-serious) Adverse Event	28 participants	28 participants

Adverse Events

Astrocytoma

Serious events: 10 serious events

Other events: 28 other events

Deaths: 0 deaths

Oligodendroglioma

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Annick Desjardins, MD, FRCPC

Duke University Medical Center

Phone: 919-668-

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Astrocytoma n=32 participants at risk Grade II Astrocytoma	Oligodendroglioma n=32 participants at risk Grade II Oligodendroglioma or oligoastrocytomas
Blood and lymphatic system disorders Anemia	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Cardiac disorders Cardiac disorders-Other, specify: Coronary artery disease	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Eye disorders Photophobia	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Gastrointestinal disorders Abdominal pain	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Gastrointestinal disorders Diarrhea	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Gastrointestinal disorders Gastric ulcer	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Gastrointestinal disorders Hemorrhoids	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Gastrointestinal disorders Nausea	9.4% 3/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Gastrointestinal disorders Vomiting	6.2% 2/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
General disorders Death NOS	6.2% 2/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
General disorders Edema face	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
General disorders Fever	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Infections and infestations Enterocolitis infectious	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Infections and infestations Lung infection	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Infections and infestations Upper respiratory infection	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Injury, poisoning and procedural complications Fracture	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Investigations Neutrophil count decreased	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Investigations White blood cell decreased	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Metabolism and nutrition disorders Hyperglycemia	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Metabolism and nutrition disorders Hypocalcemia	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Metabolism and nutrition disorders Hypokalemia	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Musculoskeletal and connective tissue disorders Chest wall pain	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Nervous system disorders Ataxia	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Nervous system disorders Dizziness	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Nervous system disorders Headache	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Nervous system disorders Seizure	6.2% 2/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Psychiatric disorders Psychosis	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Renal and urinary disorders Renal and urinary disorders-Other, specify: Renal and splenic infarcts	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	0.00% 0/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Vascular disorders Thromboembolic event	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.	3.1% 1/32 • 156 weeks All adverse events were gathered for the study using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.