A Phase I Single Arm Open Label Study of Erlotinib and 13-cis-Retinoic Acid (CRA) in Patients With Recurrent Malignant Gliomas
I. To determine the recommended phase II doses of erlotinib (erlotinib hydrochloride) and
13-cis-retinoic acid (CRA) when administered to adults with recurrent malignant glioma who
are not receiving cytochrome P450 enzyme-inducing antiepileptic drugs (EIAEDs).
I. To assess dose-related toxicities. II. To measure 6 month progression-free survival and
overall survival. III. To estimate response rates in those patients with measurable disease.
IV. To evaluate for epidermal growth factor receptor (EGFR)vIII, phosphatase and tensin
homolog (PTEN), cyclin D1, cyclin E, and RARbeta1 expression in tumor samples from enrolled
patients as predictors of clinical benefit from this combination.
OUTLINE: This is a dose-escalation study.
Patients receive isotretinoin orally (PO) once daily (QD) on days 1-21 and erlotinib
hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II doses of erlotinib hydrochloride and isotretinoin
At least 3 patients will be treated at each dose level and the maximum tolerated dose (MTD) will be determined. Patients will be evaluated for dose-limiting toxicity (DLT) in the first 3 weeks on protocol.
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|