VEGF Trap in Treating Patients With Recurrent Malignant Gliomas That Did Not Respond to Temozolomide
Completed · Phase 2
Conditions studied: Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
In brief
This phase II trial is studying how well VEGF Trap works in treating patients with recurrent malignant or anaplastic gliomas that did not respond to temozolomide. VEGF Trap may stop the growth of malignant or anaplastic gliomas by blocking blood flow to the tumor.
Key facts
- Study ID
- NCT00369590
- Run by
- National Cancer Institute (NCI)
- People needed
- 58
- Starts
- 2006-08-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2015-10-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- International Normalized Ratio (INR) < = 1.5
- Platelet count => 100,000/mm³
- Hemoglobin => 10 g/dL (transfusion allowed)
- Serum glutamic oxaloacetic transaminase (SGOT)/Serum glutamic pyruvic transaminase (SGPT) < = 2 times upper limit of normal (ULN)
- Not pregnant or nursing
- Negative pregnancy test
- No previous Vascular endothelial growth factor (VEGF) Trap
- At least 4 weeks since chemotherapy, surgery, or open biopsy
- At least 2 weeks since vincristine
- At least 6 weeks since carmustine, lomustine, fotemustine, or radiation therapy
- At least 42 days since prior nitrosoureas
- At least 3 weeks since procarbazine
- No previous Gliadel wafers or bevacizumab
- Tumor did not respond to previous radiation therapy and temozolomide
- Karnofsky performance status (KPS) 60-100%
- Life expectancy = > 8 weeks
- White blood count (WBC) = >3,000/mm³
- Absolute neutrophil count = > 1,500/mm³
- Bilirubin < = 2 times ULN
- Creatinine < = 1.5 mg/dL OR creatinine clearance= > 60 mL/min
- Urine protein:creatinine ratio < = 1 OR 24-hour urine protein < = 500 mg/dL
- Fertile patients must use effective contraception prior to, during, and for = > 6 months after completion of study treatment
- No significant medical illnesses that, in the opinion of the investigator, cannot be adequately controlled with appropriate therapy or would preclude compliance with study treatment
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to other agents used in the study
Where it is running
- University of California Los Angeles — Los Angeles, California, United States
- University of California San Francisco — San Francisco, California, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- M D Anderson Cancer Center — Houston, Texas, United States
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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