Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma

Part of paid clinical trials in Summit, New Jersey.

Sponsor
NYU Langone Health
Study ID
NCT01105702
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Temozolomide — DRUG
  • Bevacizumab — DRUG
  • Lithium Carbonate — DRUG
  • Radiation — RADIATION

Study Details

This pilot phase II trial studies how well giving temozolomide, bevacizumab, lithium carbonate, and radiation therapy works in treating patients with newly diagnosed high grade glioma.

Key Dates

First listed
Apr 16, 2010
Start date
May 31, 2010
Status verified
Jul 2016
Primary completion
Apr 30, 2014
Completion
Apr 30, 2015

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TBL/RT
    Cycle 1(One 42-day cycle) * Temozolomide 75 mg/m\^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment * Radiation within 3-5 weeks of surgery * Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks Treatment Cycles 2-7 (28 days per cycle) * Temozolomide at a dose of 150 mg/m\^2 on Days 1-7 * Bevacizumab 10 mg/kg on Day 8 and Day 22 * Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L.

Primary Outcome Measure

Median Progression-Free Survival (PFS) [ Time Frame: Up to 50 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Overlook HospitalSummitNew Jersey07902-
New York University Clinical Cancer CenterNew YorkNew York10016-

Find similar trials in Summit, NJ

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Overlook Hospital· Summit, NJNew York University Clinical Cancer Center· New York, NY

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