Cilengitide and Sunitinib Malate in Treating Patients With Advanced Solid Tumors or Glioblastoma Multiforme
|Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Solid Neoplasm Recurrent Adult Brain Neoplasm||Drug: Cilengitide Other: Clinical Observation Other: Laboratory Biomarker Analysis||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Biomarker Study of the Integrin AlphavBeta3 Antagonist Cilengitide (EMD121974) in Combination With Sunitinib|
- Change in serum VEGFR2 [ Time Frame: Over 14 days from the end of sunitinib to the end of course 1 ]
- Comparison of the change in serum VEGFR2 in courses 1 and 2 [ Time Frame: Over 14 days ]Compared using a paired t-test.
- Progression-free survival [ Time Frame: Assessed up to 30 days after completion of study treatment ]Estimated using the Kaplan-Meier method. Summarized by type, grade, and attribution and compared using chi-squared tests or Fisher exact tests, as appropriate.
- Response rate evaluated using RECIST criteria [ Time Frame: Up to 30 days after completion of study treatment ]Summarized by type, grade, and attribution and compared using chi-squared tests or Fisher exact tests, as appropriate.
- Serum type I collagen c-telopeptide crosslink measurements [ Time Frame: Up to 30 days after completion of study treatment ]
- Toxicity rates, graded using the NCI CTCAE version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ]Compared using chi-squared tests or Fisher exact tests, as appropriate.
|Study Start Date:||December 2009|
|Study Completion Date:||April 2015|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm I (course 1)
Patients receive cilengitide IV over 1 hour twice weekly for 2 weeks.
Other Names:Other: Laboratory Biomarker Analysis
Arm II (course 1)
Patients do not receive treatment and undergo a 2-week rest period.
Other: Clinical Observation
Patients undergo a 2-week rest periodOther: Laboratory Biomarker Analysis
I. Determine the effect of cilengitide on changes in serum VEGFR2, a pharmacodynamic biomarker of sunitinib malate effects on endothelial function, during the withdrawal phase of a course of sunitinib malate in patients with advanced solid tumors or glioblastoma multiforme.
I. Determine the effect of cilengitide exposure on changes in VEGFR2 over the 14-day interval from the end of sunitinib malate administration to the end of course 1 in these patients.
II. Test the safety and efficacy of this regimen in these patients. III. Develop serum collagen c-telopeptide crosslinks (CTx) as a pharmacodynamic marker for cilengitide.
COURSE I: Patients receive oral sunitinib malate on days 1-14 (weeks 1-2). Patients are then randomized to 1 of 2 treatment arms.
ARM I: Patients receive cilengitide IV over 1 hour twice in weeks 3 and 4.
ARM II: Patients do not receive treatment in weeks 3 and 4.
COURSE II: Patients in both arms then receive oral sunitinib malate on days 1-14 and cilengitide IV over 1 hour twice in weeks 3 and 4. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up periodically.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122888
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Michael Maitland||University of Chicago Comprehensive Cancer Center|