Trial Outcomes & Findings for Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma (NCT NCT00354913)
NCT ID: NCT00354913
Last Updated: 2013-01-18
Results Overview
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months. For each participant, PFS was assessed at 6 months after treatment initiation.
Results posted on
2013-01-18
Participant Flow
Participant milestones
| Measure |
Imatinib Mesylate+Hydroxyurea
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma
Baseline characteristics by cohort
| Measure |
Imatinib Mesylate+Hydroxyurea
n=21 Participants
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
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|---|---|
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Age Continuous
|
54.0 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months. For each participant, PFS was assessed at 6 months after treatment initiation.Population: Intent-to-treat
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause.
Outcome measures
| Measure |
Imatinib Mesylate+Hydroxyurea
n=21 Participants
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
|
|---|---|
|
Progression-free Survival at 6 Months
|
61.9 percentage of participants
Interval 38.1 to 78.8
|
SECONDARY outcome
Timeframe: From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months.Population: Intent-to-treat
Time in months from the start of study treatment to the date of first progression according to 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
| Measure |
Imatinib Mesylate+Hydroxyurea
n=21 Participants
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
|
|---|---|
|
Median Progression-free Survival (PFS)
|
7 months
Interval 3.8 to 9.2
|
SECONDARY outcome
Timeframe: From the date of study treatment initiation to the date of death from any cause, assessed up to 69 months.Population: Intent-to-treat
Time in months from the start of study treatment 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
| Measure |
Imatinib Mesylate+Hydroxyurea
n=21 Participants
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
|
|---|---|
|
Median Overall Survival (OS)
|
66 months
Interval 20.7 to 66.0
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SECONDARY outcome
Timeframe: 69 MonthsPopulation: Intent-to-treat
Percentage of participants with an objective response (complete response or partial response). Per modified Macdonald criteria and assessed by MRI, complete response (CR) was the disappearance of all target lesions and partial response (PR) was a ≥50% decrease in the sum of the longest diameter of target lesions. Objective response = CR+PR.
Outcome measures
| Measure |
Imatinib Mesylate+Hydroxyurea
n=21 Participants
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
|
|---|---|
|
Objective Response Rate
|
0 percentage of participants
|
Adverse Events
Imatinib Mesylate+Hydroxyurea
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imatinib Mesylate+Hydroxyurea
n=21 participants at risk
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
|
|---|---|
|
Infections and infestations
Sepsis
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
Other adverse events
| Measure |
Imatinib Mesylate+Hydroxyurea
n=21 participants at risk
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
23.8%
5/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Blurred Vision
|
19.0%
4/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Extraocular muscle paresis
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Eye disorders-Other, Inflammation: right eye
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Eye pain
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Vitreous hemorrhage
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Abdominal distension
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Constipation
|
14.3%
3/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
2/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other: increased Appetite
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Mucositis oral
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Nausea
|
23.8%
5/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Edema limbs
|
9.5%
2/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fatigue
|
19.0%
4/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Non-cardiac chest pain
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Infections and infestations-Other: ear drainage
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Upper respiratory infection
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Investigations-Other: BUN, high
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Neutrophil count decreased
|
19.0%
4/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Platelet count decreased
|
14.3%
3/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Weight gain
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
White blood count decreased
|
14.3%
3/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.5%
2/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
2/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Ataxia
|
9.5%
2/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Cognitive disturbance
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Depressed level of consciousness
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dizziness
|
14.3%
3/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dysphasia
|
9.5%
2/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Headache
|
14.3%
3/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Memory impairment
|
14.3%
3/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Nervous systems disorders-Other: gait
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Nervous system disorders-Other: Mood Alteration NOS
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.5%
2/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Pyramidal tract syndrome
|
9.5%
2/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Agitation
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Confusion
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Insomnia
|
14.3%
3/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Psychosis
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Renal and urinary disorders-Other: nocturia
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders-Other: NOS
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
1/21
Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place