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Brief Title: Cetuximab, Bevacizumab and Irinotecan for Patients With Malignant Glioblastomas
Official Title: A Phase II Trial With Cetuximab, Bevacizumab and Irinotecan for Patients With Malignant Glioblastomas and Progression After Radiation Therapy and Temozolamide
Study ID: NCT00463073
Brief Summary: Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The activity is limited, with an approximately 15 % response rate and a progression-free survival of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and the high-level expression of vascular endothelial growth factor on malignant gliomas, one would expect synergy between bevacizumab and irinotecan against gliomas. In addition, 40-50 % of GBM have EGFR amplification/mutation making the EGFR an additional target. By combing cetuximab, with irinotecan and bevacizumab, one would expect further response, than irinotecan and bevacizumab alone. In addition, recurrent gliomas have an extremely poor prognosis, so innovative therapies are needed.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aalborg University Hospital, Aalborg, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Odense University Hospital, Odense, , Denmark
Name: Ulrik Lassen, MD., PH.D.
Affiliation: Rigshospitalet, Dept. of Oncology
Role: PRINCIPAL_INVESTIGATOR