Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00555399
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Anaplastic Glioma
  • Glioblastoma Multiforme

Eligibility Criteria

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

Interventions

  • Vorinostat — DRUG
    Phase I/Arm 1: Level 0 = 300 mg PO x 14 days; Level I = 400 mg PO x 14 days; Level II = 500 mg PO x 14 days. Phase I/Arm 3: Level -II = 300 mg PO x 14 days; Level -I = 400 mg PO x 14 days; Level 0 = 400 mg PO x 14 days; Level I = 500 mg PO x 14 days.
  • Isotretinoin — DRUG
    Phase I/Arm 1: Level 0 = 100 mg/m\^2/day PO x 21 days; Level I = 100 mg/m\^2/day PO x 21 days; Level II = 100 mg/m\^2/day PO x 21 days. Phase I/Arm 2: Level 0 = 100 mg/m\^2/day PO x 21 days; Level I = 100 mg/m\^2/day PO x 21 days; Level II = 100 mg/m\^2/day PO x 21 days. Phase I/Arm 3: Level -II = 100 mg/m\^2/day PO x 21 days; Level -I = 100 mg/m\^2/day PO x 21 days; Level 0 = 100 mg/m\^2/day PO x 21 days; Level I = 100 mg/m\^2/day PO x 21 days; Level II = 100 mg/m\^2/day PO x 21 days.
  • Surgical Resection — PROCEDURE
    Surgical Resection for recurrent Glioblastoma Multiforme
  • Temozolomide — DRUG
    Phase I/Arm 2: All Levels = 150 mg/m2/day PO X 14 days. Phase I/Arm 3: Level 0 = 150 mg/m2/day PO X 14 days; Level I = 150 mg/m2/day PO X 14 days; Level -I = 125 mg/m2/day PO X 14 days; Level -II = 125 mg/m2/day PO X 14 days; Level -III = 100 mg/m2/day PO X 14 days.

Study Details

The goal of this clinical research study is to learn if vorinostat when given with isotretinoin and temozolomide can help to control glioblastoma or gliosarcoma. The safety of these drug combinations will also be studied.

Key Dates

Start date
Nov 28, 2007
Status verified
Jul 2024
Primary completion
Jan 24, 2020
Completion
Jan 24, 2020

Study Design

Enrollment
55 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ph I: Arm 1
    Vorinostat plus isotretinoin
  • Experimental: Ph I: Arm 2
    Temozolomide plus isotretinoin
  • Experimental: Ph I: Arm 3
    Vorinostat plus isotretinoin plus temozolomide
  • No Intervention: Ph II: Arm 1
    Non-Surgical
  • Other: Ph II: Arm 2
    Surgical Arm

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 62 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

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

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