Ph I SU011248 + Irinotecan in Treatment of Pts w MG

July 18, 2014 updated by: Duke University

A Phase I Study of SU011248 Plus Irinotecan in the Treatment of Patients With Malignant Glioma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine MTD & DLT of SU011248 + Irinotecan in pts w RMG not on EIAEDs
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Demographic & baseline characteristics
Time Frame: 6 months
6 months
Efficacy observations & measurements
Time Frame: 6 months
6 months
Safety observations & measurements
Time Frame: 6 months
6 months
PK measurements
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 29, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

July 21, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00000931

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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