Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT01103375
Phase
PHASE1
Status
Terminated

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib hydrochloride — DRUG
    Given PO
  • isotretinoin — DRUG
    Given PO
  • laboratory biomarker analysis — OTHER
    Correlative study
  • protein expression analysis — GENETIC
    Correlative study

Study Details

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

Key Dates

First listed
Apr 14, 2010
Start date
May 31, 2010
Status verified
Jul 2018
Primary completion
Jan 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (enzyme inhibitor, immunotherapy)
    Patients receive isotretinoin PO QD on days 1-21 and erlotinib hydrochloride PO QD on days 1-28.

Primary Outcome Measure

Recommended phase II doses of erlotinib hydrochloride and isotretinoin [ Time Frame: 3 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-

Find similar trials in Winston-Salem, NC

By research site
Wake Forest University Health Sciences· Winston-Salem, NC

Related Studies