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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

  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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      10 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  40.0% 
Male      6  60.0% 
Region of Enrollment 
[Units: Participants]
 
United States   10 


  Outcome Measures

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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
e-mail: edward.pan@moffitt.org



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