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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01110876
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Vorinostat — DRUG
    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.
  • Erlotinib — DRUG
    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.
  • Temozolomide — DRUG
    125 mg/m2 by mouth daily on days 1-7, 15-21 of each 28 day cycle.

Study Details

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.

Key Dates

Start date
Jun 30, 2011
Status verified
Aug 2021
Primary completion
Jul 31, 2014
Completion
Jul 31, 2014

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Group 1: Vorinostat + Erlotinib + Temozolomide
    Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Starting doses Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m\^2 orally once daily on Days 1-7 and 15-21.
  • Experimental: Phase I Group 2: Vorinostat + Erlotinib
    This Phase I arm to be activated only after completion of Part A of the Phase II trial of the 3-Drug combination. If part A of the Phase II trial shows lack of efficacy, trial will be terminated. Vorinostat orally twice daily, Days 1-14; and Erlotinib orally once daily Days 1-21 of every cycle.
  • Experimental: Phase II Part A 3-Drug Combination
    Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study. Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m\^2 orally once daily on Days 1-7 and 15-21.
  • Experimental: Phase II Part B 2-Drug Combination
    This Phase II Part B arm to be activated only after completion of Part A of the Phase I and II Part A trial of the 3-Drug combination. If part A of the Phase II trial shows lack of efficacy, trial will be terminated. Vorinostat orally twice daily, Days 1-14; and Erlotinib orally once daily Days 1-21 of every cycle.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Vorinostat in Combination With Escalating Doses of Erlotinib and Temozolomide [ Time Frame: Evaluated with each 28 day (+2 days) cycle, up to 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
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By specialty
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By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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