Who is sponsoring NCT01110876?

NCT01110876 is sponsored by M.D. Anderson Cancer Center.

What condition does NCT01110876 study?

NCT01110876 studies Brain Cancer, Glioblastoma Multiforme.

What drugs are being tested in NCT01110876?

Interventions: Vorinostat, Erlotinib, Temozolomide.

What is the status of NCT01110876?

NCT01110876 is currently TERMINATED.

Last reviewed 2021-08-02 · How we verify

Phase I / II Adaptive Randomized Trial of Vorinostat, Erlotinib and Temozolomide in Adults With Recurrent Glioblastoma Multiforme

NCT01110876 Phase 1/Phase 2 TERMINATED Results posted

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.

Details

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1/Phase 2
Status	TERMINATED
Enrolment	21
Start date	2011-06
Completion	2014-07

Conditions

Brain Cancer
Glioblastoma Multiforme

Interventions

Vorinostat
Erlotinib
Temozolomide

Primary outcomes

Maximum Tolerated Dose (MTD) of Vorinostat in Combination With Escalating Doses of Erlotinib and Temozolomide — Evaluated with each 28 day (+2 days) cycle, up to 24 weeks
Phase I assessment MTD Vorinostat in combination with escalating doses of Erlotinib and Temozolomide using conventional phase I design where 3 enrolled into first dose level, monitored for 3 weeks and if no dose-limiting toxicity (DLT) seen, 3 more enrolled at next dosage level. If 2/6 participants experience DLT, the previous (lower) dosage level declared MTD of vorinostat in combination with Erlotinib and Temozolomide. A maximum of 4 dosage levels utilized with deescalation by 2 dose levels if DLT is seen at the starting dose level. If no DLT noted after dose escalation to Level 4, these doses utilized as MTD for phase II.

Countries

United States