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
fenretinide
+ therapeutic conventional surgery
+ pharmacological study
Astrocytoma+11
+ Glioblastoma
+ Glioma
Treatment Study
Summary
Study start date: December 1, 2003
Actual date on which the first participant was enrolled.PRIMARY OBJECTIVES: 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 regimens. III. Determine whether this drug induces apoptosis in glioma tissue in patients treated with these regimens. 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 surgical resection. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.42 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location