Cilengitide and Sunitinib Malate in Treating Patients With Advanced Solid Tumors or Glioblastoma Multiforme
Stopped early · Phase 1
Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Solid Neoplasm, Recurrent Adult Brain Neoplasm
In brief
This clinical trial is studying how well giving cilengitide together with sunitinib malate works in treating patients with advanced solid tumors or glioblastoma multiforme. Cilengitide and sunitinib malate may stop the growth of tumor cells by blocking blood flow to the tumor. Giving cilengitide together with sunitinib malate may kill more tumor cells. Studying samples of blood in the laboratory from patients receiving cilengitide and sunitinib malate may help doctors understand the effect of these drugs on biomarkers.
Key facts
- Study ID
- NCT01122888
- Run by
- National Cancer Institute (NCI)
- People needed
- 41
- Starts
- 2009-12-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2015-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed solid tumor or malignant glioblastoma multiforme meeting >= 1 of the following criteria:
- Disease refractory to standard therapy
- No standard therapy exists
- Sunitinib malate monotherapy would be appropriate management
- Measurable disease is not required
- Previously treated brain metastases or primary brain neoplasms allowed provided patient is not receiving concurrent corticosteroids
- Karnofsky performance status 70-100%
- Absolute neutrophil count (ANC) >= 1,500/μL
- White blood cell count (WBC) >= 3,000/μL
- Platelet count >= 100,000/μL
- Hemoglobin >= 9 g/dL
- Total bilirubin normal (unless due to documented Gilbert syndrome)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal (ULN) (< 5 times ULN in the presence of liver metastases)
- Creatinine normal OR creatinine clearance >= 60 mL/min
- Serum calcium =< 12.0 mg/dL
- QTc < 500 msec
- Patients with any of the following are allowed provided they have New York Heart Association (NYHA) class I-II cardiac function and undergo a baseline echocardiogram (ECHO)/multiple gated acquisition (MUGA):
- History of class II heart failure and asymptomatic on treatment
- Prior anthracycline exposure
- Previously treated with central thoracic radiotherapy that included the heart in the radiotherapy port
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
- No concurrent uncontrolled illness including, but not limited to, any of the following:
Where it is running
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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