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
18 Years
N/A
Both
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
Trial Information
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
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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Progression-free survival (PFS)
Outcome Time Frame:
Up to 6 months
Safety Issue:
No
Principal Investigator
Vinay K. Puduvalli
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02566
NCT ID:
NCT00075491
Start Date:
December 2003
Completion Date:
Related Keywords:
- Adult Giant Cell Glioblastoma
- Adult Glioblastoma
- Adult Gliosarcoma
- Recurrent Adult Brain Tumor
- Brain Neoplasms
- Glioblastoma
- Gliosarcoma
Name | Location |
|---|---|
| M D Anderson Cancer Center | Houston, Texas 77030 |
