A Phase II Study Of Gliadel, Concomitant Temozolomide And Radiation, Followed By Dose Dense Therapy With Temozolomide Plus Bevacizumab For Newly Diagnosed Malignant High Grade Glioma

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Kentuckiana Cancer Institute
Study ID
NCT00660621
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Temozolomide and Bevacizumab — DRUG
    Between 14 and 28 days after surgery, all subjects will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin with concomitant temozolomide at a daily dose of 75 mg/m2 (7 days/week). No later than 45 days after date of completion of radiation therapy, all subjects will begin dose dense temozolomide at dose of 150 mg/m2 on Days 1-7 and 15-21 of a 28 day cycle with concomitant bevacizumab 10mg/kg administered intravenously every other week.

Study Details

To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer implantation, followed by concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide and bevacizumab in subjects undergoing initial surgery for newly-diagnosed high grade glioma.

Key Dates

First listed
Apr 17, 2008
Start date
Apr 30, 2008
Status verified
Jan 2010
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Safety and efficacy of concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide and bevacizumab in subjects undergoing initial surgery for newly-diagnosed high grade glioma. [ Time Frame: First 5 subjects after 6 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kentuckiana Cancer InstituteLouisvilleKentucky40202
Roxann R. Smalley, JD
[email protected]
502-561-8200
Renato V. LaRocca, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Louisville, KY

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Kentuckiana Cancer Institute· Louisville, KY

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