Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase II trial is studying how well neoadjuvant and adjuvant fenretinide works compared to adjuvant fenretinide alone in treating patients who are undergoing surgical resection for recurrent glioblastoma multiforme. Chemotherapy drugs, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether neoadjuvant and adjuvant fenretinide is more effective than adjuvant fenretinide alone

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Fenretinide

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)