A Phase II Evaluation With Correlative Studies Of Fenretinide (NSC 374551-4HPR) As A Single Agent In The Treatment Of Adult Patients With Recurrent Glioblastoma Multiforme

Date de début de l'étude : 1 décembre 2003

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)