MedTrace Logo

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

NCT00555399 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-08-22

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

DRUG

Vorinostat

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.

DRUG

Isotretinoin

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.

PROCEDURE

Surgical Resection

Surgical Resection for recurrent Glioblastoma Multiforme

DRUG

Temozolomide

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.

Sponsors & Collaborators

Principal Investigators

  • Marta Penas-Prado, MD · M.D. Anderson Cancer Center

  • Vinay Puduvalli, MD · Brain Tumor Trials Collaborative (BTTC), and Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-28
Primary Completion
2020-01-24
Completion
2020-01-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00555399 on ClinicalTrials.gov