Ph I SU011248 + Irinotecan in Treatment of Pts w MG

NCT00611728

Last updated date
Study Location
Duke University Health System
Durham, North Carolina, 27710, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glioblastoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Pts confirmed GBM, GS, AA, AO & AOA w recurrent disease following standard therapy consisting of at least external beam XRT & temo chemo

- Pts not had tumor biopsy <1 week/surgical resection <2 weeks prior to starting study drug

- Pts should be on non-increasing dose of steroids >7 days prior to obtaining baseline Gd-MRI of brain

- Age >18yrs

- KPS >70

- ANC >1.5 x 10 9/L

- Hgb >9 g/dL

- Platelets >100 x 10 9/L

- AST/SGOT & ALT/SGPT <2.5 x ULN

- Serum bilirubin <1.5 x ULN

- Serum CA <12 mg/dL

- Serum creatinine <1.5 x ULN/measured 24-hr CrCl>50mL/min/1.73m^2

- Pt has ability to understand & provide signed informed consent that fulfills IRB guidelines

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior gr3/>toxicity/failure to CPT-11 therapy


- Prior Sunitinib malate therapy


- Concurrent administration of EIAEDs


- Major surgery <2 weeks of enrollment


- History of impaired cardiac function


- Other clinically significant cardiac diseases


- Uncontrolled diabetes


- Active/uncontrolled infection requiring intravenous antibiotics


- Impairment of GI function/GI disease that may significantly alter absorption of
Sunitinib malate Sutent


- Acute/chronic liver/renal disease


- Cerebrovascular accident/transient ischemic attack <6mths of study enrollment


- Pulmonary embolism <6mths of study enrollment


- Pre-existing thyroid abnormality w thyroid function that can not be maintained in
normal range w medication


- Pts taking warfarin sodium


- Pts have received chemo ≤4wks to starting study drug unless they have fully recovered
from all anticipated side effects of such therapy


- Pts have received immunotherapy ≤2wks to starting study drug/have not recovered from
side effects of such therapy


- Pts have received investigational drugs ≤2wks to starting study drug unless they have
fully recovered from all anticipated side effects of such therapy


- Pts have received XRT ≤4wks to starting study drug unless they have fully recovered
from all anticipated side effects of such therapy


- Pts have undergone major non-CNS surgery ≤2wks to starting study drug/pts who have not
recovered from side effects of such therapy


- Cardiac pacemaker


- Ferromagnetic metal implants other than those approved as safe for use in MR scanners


- Claustrophobia


- Obesity


- Female pts who are pregnant/breast feeding/adults of reproductive potential not
employing effective method of birth control


- Known diagnosis of HIV


- History of another primary malignancy that is currently clinically
significant/currently requiring active intervention


- Pts unwilling to/unable to comply w protocol


- Existing intra-tumoral hemorrhage


- Concurrent participation in another clinical trial except for supportive
care/non-treatment trials


- Other severe acute/chronic medical/psychiatric condition/lab abnormality that may
increase risk associated w study participation/study drug administration/ may
interfere w interpretation of study results, & in judgment of investigator would make
subject inappropriate for entry into this study

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Advanced Information
Descriptive Information
Brief Title  ICMJE Ph I SU011248 + Irinotecan in Treatment of Pts w MG
Official Title  ICMJE A Phase I Study of SU011248 Plus Irinotecan in the Treatment of Patients With Malignant Glioma
Brief Summary Primary Objectives To determine maxi tolerated dose & dose limiting toxicity of SU011248 + Irinotecan in recurrent MG pts not on EIAEDs To characterize safety & tolerability of SU011248 + Irinotecan among pts w recurrent MG Secondary Objectives To evaluate pharmacokinetic profile of SU011248 & Irinotecan when co-administered in pts w MG To evaluate anti-tumor activity of SU011248 + Irinotecan
Detailed Description

Primary interest for combining SU011248 w irinotecan in malignant glioma pts derives from dramatic anti-tumor activity recently demonstrated among RMG pts treated w humanized anti-VEGF monoclonal antibody, bevacizumab, when combined w irinotecan. 63 percent radiographic response rate was observed following treatment w regimen every other wk, & median progression-free survival was 23wks. Similar enhancement of chemo activity by VEGF-directed therapy w bev has been previously demonstrated for colorectal & lung cancer pts. SU011248 is being evaluated in current regimen because it may exert more potent anti-angiogenic effect than bev among MG pts due to its ability to inhibit PDGFR-mediated pericyte stabilization in tumor neovasculature.

Current proposed ph I study is designed to determine MTD & DLT of SU011248 when combo w irinotecan for pts w RMG. Both SU01148 & irinotecan are known to be metabolized by CYP3A4 cytochrome system. Current study will limit enrollment to pts who are not on CYP3A4-enzyme inducing anti-epileptic drugs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE Drug: SU011248 & Irinotecan

Sutent given in daily oral manner for 1st 4 wks of each 6wk cycle. You will not take any Sutent during last 14 days of each 6 wk cycle. CPT-11 will be given intravenously over 1 & 1/2 hrs on 1st day of each cycle & then again on days 14 & 28.

Sutent is approved for adult subjects w some forms of kidney cancer. It is considered "investigational" for brain tumors. Dosing will begin on day 1 of cycle 1 & continue daily for 4 wks by mouth.

Irinotecan is approved for adult subjects with some forms of colorectal cancer. It is also considered "investigational" for brain tumors. Irinotecan dose will depend on your height & weight. Irinotecan will be given intravenously over 90 min on days 1, 14 & 28 of 6wk cycle.

You will be seen in clinic approximately every 42 days for 1st 3 cycles of study drug, & then every other cycle thereafter. Your brain MRI examination will be done within 1 wk prior to completion of cycles 1-3, & then within 1 week prior to completion of every other cycle.

Other Names:
  • SU011248-Sutent-Sunitinib
  • Irinotecan-CPT 11-Camptosar
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2011)
25
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2008)
30
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pts confirmed GBM, GS, AA, AO & AOA w recurrent disease following standard therapy consisting of at least external beam XRT & temo chemo
  • Pts not had tumor biopsy <1 week/surgical resection <2 weeks prior to starting study drug
  • Pts should be on non-increasing dose of steroids >7 days prior to obtaining baseline Gd-MRI of brain
  • Age >18yrs
  • KPS >70
  • ANC >1.5 x 10 9/L
  • Hgb >9 g/dL
  • Platelets >100 x 10 9/L
  • AST/SGOT & ALT/SGPT <2.5 x ULN
  • Serum bilirubin <1.5 x ULN
  • Serum CA <12 mg/dL
  • Serum creatinine <1.5 x ULN/measured 24-hr CrCl>50mL/min/1.73m^2
  • Pt has ability to understand & provide signed informed consent that fulfills IRB guidelines

Exclusion Criteria:

  • Prior gr3/>toxicity/failure to CPT-11 therapy
  • Prior Sunitinib malate therapy
  • Concurrent administration of EIAEDs
  • Major surgery <2 weeks of enrollment
  • History of impaired cardiac function
  • Other clinically significant cardiac diseases
  • Uncontrolled diabetes
  • Active/uncontrolled infection requiring intravenous antibiotics
  • Impairment of GI function/GI disease that may significantly alter absorption of Sunitinib malate Sutent
  • Acute/chronic liver/renal disease
  • Cerebrovascular accident/transient ischemic attack <6mths of study enrollment
  • Pulmonary embolism <6mths of study enrollment
  • Pre-existing thyroid abnormality w thyroid function that can not be maintained in normal range w medication
  • Pts taking warfarin sodium
  • Pts have received chemo ?4wks to starting study drug unless they have fully recovered from all anticipated side effects of such therapy
  • Pts have received immunotherapy ?2wks to starting study drug/have not recovered from side effects of such therapy
  • Pts have received investigational drugs ?2wks to starting study drug unless they have fully recovered from all anticipated side effects of such therapy
  • Pts have received XRT ?4wks to starting study drug unless they have fully recovered from all anticipated side effects of such therapy
  • Pts have undergone major non-CNS surgery ?2wks to starting study drug/pts who have not recovered from side effects of such therapy
  • Cardiac pacemaker
  • Ferromagnetic metal implants other than those approved as safe for use in MR scanners
  • Claustrophobia
  • Obesity
  • Female pts who are pregnant/breast feeding/adults of reproductive potential not employing effective method of birth control
  • Known diagnosis of HIV
  • History of another primary malignancy that is currently clinically significant/currently requiring active intervention
  • Pts unwilling to/unable to comply w protocol
  • Existing intra-tumoral hemorrhage
  • Concurrent participation in another clinical trial except for supportive care/non-treatment trials
  • Other severe acute/chronic medical/psychiatric condition/lab abnormality that may increase risk associated w study participation/study drug administration/ may interfere w interpretation of study results, & in judgment of investigator would make subject inappropriate for entry into this study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00611728
Other Study ID Numbers  ICMJE Pro00000931
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:David A. Reardon, MDDuke University Health System
PRS Account Duke University
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP