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

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ClinicalTrials.gov Identifier: NCT00360828
Recruitment Status : Terminated (Principal Investigator left Moffitt and study had low accrual.)
First Posted : August 7, 2006
Results First Posted : December 9, 2011
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Astrocytoma
Glioma
Oligodendroglioma
Interventions Drug: Irinotecan Hydrochloride (HCI) Treatment
Drug: Continued Irinotecan Hydrochloride (HCI) Treatment
Enrollment 10
Recruitment Details  
Pre-assignment Details A total of 12 consented, 2 were not eligible after the screening process.
Arm/Group Title Irinotecan Hydrochloride (HCI) Treatment
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 10
Completed 9
Not Completed 1
Arm/Group Title Irinotecan Hydrochloride (HCI) Treatment
Hide Arm/Group Description 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 Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Number of Participants With Objective Response After 3 Cycles of Treatment
Hide Description 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.
Time Frame 3 cycles (21 day cycles)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants having stable disease
Arm/Group Title Irinotecan Hydrochloride (HCI) Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
8
2.Secondary Outcome
Title Overall Survival at 6 Months
Hide Description Patients surviving 6 months after treatment end
Time Frame 6 months post treatment end
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of drug
Arm/Group Title Irinotecan Hydrochloride (HCI) Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
6
3.Secondary Outcome
Title Progression Free Survival
Hide Description Patients surviving at one year post treatment end
Time Frame 1 year post treatment end
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The low accrual rate prevented us from completing the planned analysis.
Arm/Group Title Irinotecan Hydrochloride (HCI) Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Frequency and Severity of Toxicity
Hide Description Toxicities assessed through 3 months
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The low accrual rate prevented us from completing the planned analysis.
Arm/Group Title Irinotecan Hydrochloride (HCI) Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival at 12 Months
Hide Description Patients surviving 12 months after last dose of drug
Time Frame 12 months post treatment end
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of drug
Arm/Group Title Irinotecan Hydrochloride (HCI) Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
6
Time Frame 1 year, 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Irinotecan Hydrochloride (HCI) Treatment
Hide Arm/Group Description 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.
All-Cause Mortality
Irinotecan Hydrochloride (HCI) Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Irinotecan Hydrochloride (HCI) Treatment
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Irinotecan Hydrochloride (HCI) Treatment
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Gastrointestinal disorders   
Diarrhea  1 [1]  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC V3
[1]
Grade 3, definitely related.
Low accrual prevented us from completing the planned analysis. The initial Principal Investigator (PI) left Moffitt and there were only 10 participants.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Edward Pan, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3871
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00360828     History of Changes
Other Study ID Numbers: MCC-14633
First Submitted: August 3, 2006
First Posted: August 7, 2006
Results First Submitted: October 3, 2011
Results First Posted: December 9, 2011
Last Update Posted: March 23, 2017