ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- 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
- 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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| 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:
| |||
| 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 | 25 | |||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||