Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
About this trial
This is an interventional treatment trial for Adult Giant Cell Glioblastoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed glioblastoma multiforme after initial tumor resection Radiologically evident recurrent tumor after prior radiotherapy OR after treatment for no more than 2 prior relapses Enhancing or nonenhancing recurrent disease by MRI No progressive symptoms requiring urgent surgery Performance status - Karnofsky 70-100% More than 8 weeks Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 PT/PTT no greater than upper limit of normal SGPT no greater than 2.5 times normal Alkaline phosphatase no greater than 2.5 times normal Bilirubin less than 1.5 mg/dL BUN no greater than 1.5 times normal Creatinine no greater than 1.5 times normal Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 2 months after study participation Amylase and lipase normal No active infection No other disease that would obscure toxicity or dangerously alter drug metabolism No other concurrent serious medical illness Not at risk from any study treatment delays Able to swallow fenretinide capsules Recovered from all prior chemotherapy Approximately 2 weeks since prior vincristine Approximately 6 weeks since prior nitrosoureas Approximately 3 weeks since prior procarbazine See Disease Characteristics At least 2 weeks since prior radiotherapy See Disease Characteristics At least 1 week since prior vitamin A At least 1 week since prior isotretinoin (Accutane®) No concurrent vitamin A during and for 2 weeks after study participation No concurrent antioxidants (e.g., ascorbic acid or vitamin E)
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I (fenretinide, surgery)
Arm II (surgery)
Patients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo surgical resection.
Patients undergo surgical resection.