Trial Outcomes & Findings for Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas (NCT NCT00360828)

Results Overview

The intent was to have 63 evaluable participants to determine the Objective Response Rate utilizing Criteria for Response, Progression and Relapse according to the McDonald Criteria. A measurement is made of the maximal enhancing tumor diameter on a single axial gadolinium-enhanced T1-weighted section, and then the largest perpendicular diameter is measured on the same image. The product of the 2 diameters is calculated, and the measurements are repeated with each scan. Measurements from multiple lesions are summed.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

3 cycles (21 day cycles)

Results posted on

2017-03-23

Participant Flow

A total of 12 consented, 2 were not eligible after the screening process.

Participant milestones

Participant milestones
Measure	Irinotecan Hydrochloride (HCI) Treatment Participants were given irinotecan at a fixed dose: \[350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan\] once every 21 days. Depending on how many side effects were experienced with the first cycle \[first 21 days\], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Irinotecan Hydrochloride (HCI) Treatment n=10 Participants Participants were given irinotecan at a fixed dose: \[350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan\] once every 21 days. Depending on how many side effects were experienced with the first cycle \[first 21 days\], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 cycles (21 day cycles)

Population: All participants having stable disease

The intent was to have 63 evaluable participants to determine the Objective Response Rate utilizing Criteria for Response, Progression and Relapse according to the McDonald Criteria. A measurement is made of the maximal enhancing tumor diameter on a single axial gadolinium-enhanced T1-weighted section, and then the largest perpendicular diameter is measured on the same image. The product of the 2 diameters is calculated, and the measurements are repeated with each scan. Measurements from multiple lesions are summed.

Outcome measures

Outcome measures
Measure	Irinotecan Hydrochloride (HCI) Treatment n=10 Participants Participants were given irinotecan at a fixed dose: \[350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan\] once every 21 days. Depending on how many side effects were experienced with the first cycle \[first 21 days\], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
Number of Participants With Objective Response After 3 Cycles of Treatment	8 participants

SECONDARY outcome

Timeframe: 6 months post treatment end

Population: All participants who received at least one dose of drug

Patients surviving 6 months after treatment end

Outcome measures

Outcome measures
Measure	Irinotecan Hydrochloride (HCI) Treatment n=10 Participants Participants were given irinotecan at a fixed dose: \[350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan\] once every 21 days. Depending on how many side effects were experienced with the first cycle \[first 21 days\], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
Overall Survival at 6 Months	6 participants

SECONDARY outcome

Timeframe: 1 year post treatment end

Population: The low accrual rate prevented us from completing the planned analysis.

Patients surviving at one year post treatment end

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: The low accrual rate prevented us from completing the planned analysis.

Toxicities assessed through 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months post treatment end

Population: All participants who received at least one dose of drug

Patients surviving 12 months after last dose of drug

Outcome measures

Outcome measures
Measure	Irinotecan Hydrochloride (HCI) Treatment n=10 Participants Participants were given irinotecan at a fixed dose: \[350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan\] once every 21 days. Depending on how many side effects were experienced with the first cycle \[first 21 days\], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
Overall Survival at 12 Months	6 participants

Adverse Events

Irinotecan Hydrochloride (HCI) Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Irinotecan Hydrochloride (HCI) Treatment n=10 participants at risk Participants were given irinotecan at a fixed dose: \[350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan\] once every 21 days. Depending on how many side effects were experienced with the first cycle \[first 21 days\], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
Gastrointestinal disorders Diarrhea	10.0% 1/10 • Number of events 1 • 1 year, 9 months

Additional Information

Edward Pan, M.D.

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-3871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place