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
I. Compare the efficacy of neoadjuvant and adjuvant fenretinide vs adjuvant fenretinide
alone, in terms of 6-month progression-free survival, in patients with recurrent
glioblastoma multiforme undergoing surgical resection II. Correlate the serum and glioma
tissue pharmacology of this drug with clinical response in patients treated with these
III. Determine whether this drug induces apoptosis in glioma tissue in patients treated with
IV. Correlate the apoptotic index with tissue and serum concentration and clinical response
in patients treated with these regimens.
V. Compare radiological response, overall survival, and unexpected toxicity in patients
treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo
Arm II: Patients undergo surgical resection.
Beginning two weeks after surgery, all patients receive adjuvant oral fenretinide twice
daily on weeks 1 and 4. Courses repeat every 6 weeks in the absence of disease progression
or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 21-46 patients (10-23 per treatment arm) will be accrued for
this study within 7-46 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression-free survival (PFS)
Up to 6 months
Vinay K. Puduvalli
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|