GlioblastomaPhase 1NCT00611728
Ph I SU011248 + Irinotecan in Treatment of Pts w MG
A Phase 1 study testing SU011248 & Irinotecan in people with Glioblastoma, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- SU011248 & Irinotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Sep 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: 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
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- SU011248 & Irinotecan
- Keywords
- Glioblastoma, CPT 11, Sutent, Sunitinib, Sunitinib malate, Malignant Glioma, GBM, Irinotecan, Camptosar, Anaplastic astrocytoma, Anaplastic oligodendroglioma, Anaplastic oligoastrocytoma, SU011248, Brain tumor, Recurrent malignant glioma
- Medical subject headings
- Glioblastoma, Glioma, Astrocytoma, Oligodendroglioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SU011248 & IrinotecanDrug
Also called SU011248-Sutent-Sunitinib, Irinotecan-CPT 11-Camptosar
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine MTD & DLT of SU011248 + Irinotecan in pts w RMG not on EIAEDs
Measured: 6 months
Secondary outcomes (4)
Demographic & baseline characteristics
Measured: 6 months
Efficacy observations & measurements
Measured: 6 months
Safety observations & measurements
Measured: 6 months
PK measurements
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- David A. Reardon, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611728
- Sponsor's protocol ID
- Pro00000931
- Status last verified
- Dec 2011
- First submitted
- 29 Jan 2008
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of SU011248 Plus Irinotecan in the Treatment of Patients With Malignant Glioma
- ClinicalTrials.gov ID
- NCT00611728
- Acronym / sponsor ID
- Pro00000931
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, CPT 11, Sutent, Sunitinib, Sunitinib malate, Malignant Glioma, GBM, Irinotecan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SU011248 & IrinotecanAlso: SU011248-Sutent-Sunitinib, Irinotecan-CPT 11-CamptosarSutent 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. | Drug | – |
Primary outcome
Determine MTD & DLT of SU011248 + Irinotecan in pts w RMG not on EIAEDs
Time frame: 6 months
4 secondary outcomes
Demographic & baseline characteristics
Time frame: 6 months
Efficacy observations & measurements
Time frame: 6 months
Safety observations & measurements
Time frame: 6 months
PK measurements
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- The Preston Robert Tisch Brain Tumor Center at DUKELink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A. Reardon, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SU011248 & Irinotecan in people with Glioblastoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine MTD & DLT of SU011248 + Irinotecan in pts w RMG not on EIAEDs (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.