Trial Outcomes & Findings for Imatinib Mesylate in Treating Patients With Recurrent Meningioma (NCT NCT00045734)

Results Overview

The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging \[MRI\]) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

At 6 months

Results posted on

2017-05-15

Participant Flow

patients enrolled between June 2003 ad August 2005 in an outpatient clinic setting.

Participant milestones

Participant milestones
Measure	Treatment (Imatinib Mesylate) Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Overall Study STARTED	23
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Imatinib Mesylate) Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Overall Study Protocol Violation	1

Baseline Characteristics

Imatinib Mesylate in Treating Patients With Recurrent Meningioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Imatinib Mesylate) n=23 Participants Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Karnofsky Performance Status Scale (KPS)	80 units on a scale n=5 Participants
Histology Benign (WHO grade I)	13 participants n=5 Participants
Histology Atypical (WHO grade II)	5 participants n=5 Participants
Histology Anaplastic (WHO grade III)	5 participants n=5 Participants
Prior Surgeries	3 surgeries n=5 Participants
Prior Radiation Therapies	1 Radiation Therapies n=5 Participants
Prior Chemotherapy Regimens	0 Chemotherapy Regimens n=5 Participants

PRIMARY outcome

Timeframe: At 6 months

Population: Only 19 of the 23 patients were evaluable for response

The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging \[MRI\]) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration

Outcome measures

Outcome measures
Measure	Treatment (Imatinib Mesylate) n=19 Participants Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria	29.4 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Of the 22 eligible patients only 19 were evaluable for response

The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration

Outcome measures

Outcome measures
Measure	Treatment (Imatinib Mesylate) n=19 Participants Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Progression-free Survival According to Response Evaluation Using Macdonald Criteria	2 months Interval 0.7 to 34.0

SECONDARY outcome

Timeframe: Up to 5 years after completion of study treatment

percentage of patients who had grade 3 or grade 4 adverse events

Outcome measures

Outcome measures
Measure	Treatment (Imatinib Mesylate) n=23 Participants Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Toxicity as Assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0	2.3 percentage of patients

SECONDARY outcome

Timeframe: Up to 5 years

Population: response at first scan

The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration

Outcome measures

Outcome measures
Measure	Treatment (Imatinib Mesylate) n=19 Participants Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Tumor Response as Assessed by MRI Using Macdonald Criteria Progression	10 participants
Tumor Response as Assessed by MRI Using Macdonald Criteria Stable	9 participants

SECONDARY outcome

Timeframe: pre dosing on day 8 and 24 hour dosing day 8 of Pre-dosing Day 9

Population: Only 14 samples available / evaluable for analysis

Blood collected before and at 1,2,4 ad 24 hours after ingestion of imatinib on day 8 of cycle 1 result is the measurement of the before dosing on day 8 (trough level) and the 24 hour dosing day 8

Outcome measures

Outcome measures
Measure	Treatment (Imatinib Mesylate) n=22 Participants Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics) Day 8 Pre Dosing	2129 ng/ml Standard Deviation 1600
Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics) Day 8 24 hour dosing	2248 ng/ml Standard Deviation 1408

SECONDARY outcome

Timeframe: 3 years

Population: death date of 7 patients were unknown at time of analysis

survival determined from start of treatment to date of death

Outcome measures

Outcome measures
Measure	Treatment (Imatinib Mesylate) n=17 Participants Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Determine Survival for Patients Treated With Imatinib Mesylate	16.8 months Interval 2.1 to 48.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due to number of patients.

Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due number of patients.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: - 3 years

Population: insufficient samples to allow PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue

insufficient samples to allow Platelet-derived growth factor receptor (PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due to number of patients.

Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): \>/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over Baseline (BL) if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Imatinib Mesylate)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Imatinib Mesylate) n=22 participants at risk Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Blood and lymphatic system disorders anemia	4.5% 1/22 • Number of events 1 • 3 years
Blood and lymphatic system disorders Leukopenia	4.5% 1/22 • Number of events 1 • 3 years
Blood and lymphatic system disorders Neutropenia	9.1% 2/22 • Number of events 2 • 3 years
Nervous system disorders CNS (intracranial) Hemorrhage	4.5% 1/22 • Number of events 1 • 3 years
Metabolism and nutrition disorders dehydrations	4.5% 1/22 • Number of events 1 • 3 years
Nervous system disorders dizziness	4.5% 1/22 • Number of events 1 • 3 years
Investigations elevated serum glutamic pyruvic transaminase	4.5% 1/22 • Number of events 1 • 3 years
Metabolism and nutrition disorders Hypophosphatemia	9.1% 2/22 • Number of events 2 • 3 years

Additional Information

Patrick Wen, MD

Adult Brain Tumor Consortium (ABTC)

Phone: 410-955-8837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60