Clinical trial · Interventional
Ph I SU011248 + Irinotecan in Treatment of Pts w MG
A Phase I Study of SU011248 Plus Irinotecan in the Treatment of Patients With Malignant Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SU011248 & Irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine MTD & DLT of SU011248 + Irinotecan in pts w RMG not on EIAEDs
- timeFrame
- 6 months
Secondary outcomes (4)
- measure
- Demographic & baseline characteristics
- timeFrame
- 6 months
- measure
- Efficacy observations & measurements
- timeFrame
- 6 months
- measure
- Safety observations & measurements
- timeFrame
- 6 months
- measure
- PK measurements
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available