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Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM)

NCT01110876 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-08-25

Study results available
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Summary

Phase I Objectives:

-To determine the maximum tolerated dose (MTD) of vorinostat + erlotinib versus vorinostat + erlotinib + temozolomide in adult patients with recurrent glioblastoma multiforme (GBM) and anaplastic gliomas.

Phase II Objectives:

Primary: To determine the efficacy of vorinostat + erlotinib versus vorinostat + erlotinib + temozolomide in patients with recurrent glioblastoma multiforme as progression free survival using a two arm adaptive randomization phase II trial design.

Secondary: To determine the radiological response, progression free survival (PFS) at 6 months, overall survival and unexpected toxicity in the two treatment arms; and to obtain exploratory data regarding histone 3 and 4 acetylation, treatment related changes in the epidermal growth factor receptor (EGFR) pathway proteins, and changes in e-cadherin and vimentin expression (mRNA /protein) levels in tumor tissue and peripheral monocytes in a subset of surgical patients.

Conditions

Interventions

DRUG

Vorinostat

Phase I Starting Dose: 200 mg twice daily by mouth on Days 1-7, 15-21 of each 28 day cycle. Phase II Dose: MTD from Phase I.

DRUG

Erlotinib

Phase I Starting Dose: 200 mg by mouth daily on Days 1-21 of 28 day cycle. For patients on enzyme inducing anticonvulsants (EIACs), starting dose of 400 mg. Phase II Dose: MTD from Phase I.

DRUG

Temozolomide

125 mg/m2 by mouth daily on days 1-7, 15-21 of each 28 day cycle.

Sponsors & Collaborators

Principal Investigators

  • John DeGroot, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01110876 on ClinicalTrials.gov