Text Size

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

This study has been terminated.
(Principal Investigator left Moffitt and study had low accrual.)
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00360828
First received: August 3, 2006
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
Results First Received: October 3, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Astrocytoma
Glioma
Oligodendroglioma
Interventions: Drug: Irinotecan Hydrochloride (HCI) Treatment
Drug: Continued Irinotecan Hydrochloride (HCI) Treatment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 12 consented, 2 were not eligible after the screening process.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Irinotecan Hydrochloride (HCI) Treatment  
STARTED     10  
COMPLETED     9  
NOT COMPLETED     1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
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.

Baseline Measures
    Irinotecan Hydrochloride (HCI) Treatment  
Number of Participants  
[units: participants]
 		  10  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     4  
Male     6  
Region of Enrollment  
[units: participants]
 		 
United States     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Objective Response After 3 Cycles of Treatment   [ Time Frame: 3 cycles (21 day cycles) ]
  Show Outcome Measure 1

2.  Secondary:   Overall Survival at 6 Months   [ Time Frame: 6 months post treatment end ]
  Show Outcome Measure 2

3.  Secondary:   Progression Free Survival   [ Time Frame: 1 year post treatment end ]
  Show Outcome Measure 3

4.  Secondary:   Frequency and Severity of Toxicity   [ Time Frame: 3 months ]
  Show Outcome Measure 4

5.  Secondary:   Overall Survival at 12 Months   [ Time Frame: 12 months post treatment end ]
  Show Outcome Measure 5


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Low accrual prevented us from completing the planned analysis. The initial Principal Investigator (PI) left Moffitt and there were only 10 participants.  


Results Point of Contact:  
Name/Title: Edward Pan, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-3871
e-mail: edward.pan@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00360828     History of Changes
Other Study ID Numbers: MCC-14633
Study First Received: August 3, 2006
Results First Received: October 3, 2011
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration