Cilengitide and Sunitinib Malate in Treating Patients With Advanced Solid Tumors or Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT01122888|
Recruitment Status : Terminated
First Posted : May 13, 2010
Last Update Posted : April 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Biomarker Study of the Integrin AlphavBeta3 Antagonist Cilengitide (EMD121974) in Combination With Sunitinib|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||April 2015|
Experimental: Arm I (course 1)
Patients receive cilengitide IV over 1 hour twice weekly for 2 weeks.
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 period
Other: Laboratory Biomarker Analysis
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|