Adult Glioblastoma Clinical Trial
Official title:
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
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
Status | Terminated |
Enrollment | 42 |
Est. completion date | |
Est. primary completion date | March 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival (PFS) | Up to 6 months | No | |
Primary | Plasma and tissue concentrations of fenretinide and its metabolite, 4-MPR using high-performance liquid chromatography (HPLC) assay | At baseline, and at 1, 7, 14, and 21 days | No | |
Primary | Tumor apoptotic index after fenretinide treatment by immunohistochemistry | At the time of surgery | No | |
Primary | Correlation between tumor apoptotic index with serum and tissue fenretinide levels | At the time of surgery | No | |
Primary | Correlation of time to progression with drug levels and apoptotic index | Up to 2 years | No | |
Secondary | Fenretinide effects on retinol, RBP, retinoid receptor levels and IGF-1 | Up to 21 days (course 1 and 4) | No | |
Secondary | Fenretinide activity using magnetic resonance spectroscopy (MRS) | At the time of surgery | No | |
Secondary | Radiological response | Up to 2 years | No | |
Secondary | Overall survival | Up to 2 years | No | |
Secondary | Unexpected toxicity associated with fenretinide as assessed by CTC version 3.0 | Up to 2 years | Yes |
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