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


Phase 1
18 Years
N/A
Not Enrolling
Both
Glioblastoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine MTD & DLT of SU011248 + Irinotecan in pts w RMG not on EIAEDs

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

David A. Reardon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System

Authority:

United States: Institutional Review Board

Study ID:

Pro00000931

NCT ID:

NCT00611728

Start Date:

March 2008

Completion Date:

September 2010

Related Keywords:

  • Glioblastoma
  • Glioblastoma
  • CPT 11
  • Sutent
  • Sunitinib
  • Sunitinib malate
  • Malignant Glioma
  • GBM
  • Irinotecan
  • Camptosar
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Anaplastic oligoastrocytoma
  • SU011248
  • Brain tumor
  • Recurrent malignant glioma
  • Glioblastoma
  • Glioma

Name

Location

Duke University Health SystemDurham, North Carolina  27705