Adult Glioblastoma Clinical Trial
Official title:
A Phase I Single Arm Open Label Study of Erlotinib and 13-cis-Retinoic Acid (CRA) in Patients With Recurrent Malignant Gliomas
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given with isotretinoin in treating patients with recurrent malignant glioma. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may help cells that are involved in the body's immune response to work better. Giving erlotinib hydrochloride together with isotretinoin may kill more tumor cells
PRIMARY OBJECTIVES:
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).
SECONDARY OBJECTIVES:
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.
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