NCT01103375

Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma

A Phase I Single Arm Open Label Study of Erlotinib and 13-cis-Retinoic Acid (CRA) in Patients With Recurrent Malignant Gliomas

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Adult Anaplastic Astrocytoma
• Adult Anaplastic Oligodendroglioma
• Adult Diffuse Astrocytoma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Adult Mixed Glioma
• Adult Oligodendroglioma
• Recurrent Adult Brain Tumor

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given PO
DRUG	isotretinoin	Given PO
OTHER	laboratory biomarker analysis	Correlative study
GENETIC	protein expression analysis	Correlative study

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-01-01
• Completion: 2013-03-01
• First posted: 2010-04-14
• Last updated: 2018-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study