Safety and Efficacy Study of TH-302 CNS Penetration in Recurrent High Grade Astrocytoma Following Bevacizumab

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT01403610
Phase
PHASE2
Status
Completed

Conditions

  • HIGH GRADE GLIOMA

Eligibility Criteria

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

Interventions

  • TH-302 preoperative — DRUG
    TH-302 single dose at 575 mg/m2 administered preoperatively, followed by postoperative combination therapy bevacizumab at 10mg/kg every 2 weeks and TH-302 at 240 - 480 mg/m2 every 2 weeks (4 week cycle) until disease progression. Subjects will be randomized (2:1) to receive pre-operative dose of TH-302.
  • Placebo — DRUG
    Placebo administered preoperatively, followed by postoperative combination therapy bevacizumab at 10mg/kg every 2 weeks and TH-302 at 240 - 480 mg/m2 every 2 weeks (4 week cycle) until disease progression. Subjects will be randomized (2:1) to receive pre-operative dose of TH-302.
  • TH-302 (escalating) with bevacizumab 10mg/kg — DRUG
    Combination of 10mg/m2 of bevacizumab with an escalating dose of TH-302 from 240 to 670 mg/m2

Study Details

The Primary Objectives are: * To determine the extent by which TH-302 is able to penetrate the blood brain barrier and affect tumor tissue * To assess the safety of single dose TH-302 in patients with high grade glioma undergoing surgery * To assess the safety of TH-302 in combination with bevacizumab for patients with high grade glioma * To determine the MTD and DLT(s) of TH-302 in combination with bevacizumab The Secondary Objectives are: To determine the progression-free survival with or without debulking craniotomy for patients treated with combination bevacizumab and TH-302 following recurrence on single agent bevacizumab

Key Dates

First listed
Jul 27, 2011
Start date
Jun 30, 2011
Status verified
Mar 2019
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
28 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Subjects received TH-302 single dose at 575 mg/m2 or placebo administered preoperative in a 2:1 randomization and were then administered 240 mg/m2 of TH-302 post-operative.
  • Experimental: Cohort 2
    Surgical subjects will receive TH-302 at 340 mg/m2 every 2 weeks (4 week cycles) starting after surgery from Cycle 1, Day 1 until disease progression.
  • Experimental: Cohort 3
    Surgical or Non-Surgical subjects will receive TH-302 at 480 mg/m2 every 2 weeks (4 week cycles) starting after surgery from Cycle 1, Day 1 until disease progression.
  • Experimental: Cohort 4
    Non-surgical subjects will receive a dose up to 670 mg/m2 of TH-302

Primary Outcome Measure

Time to Progression [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer Therapy & Research Center at UTHSCSASan AntonioTexas78229-

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