Magnetic Resonance Spectroscopy Imaging in Predicting Response to Vorinostat and Temozolomide in Patients With Recurrent or Progressive Glioblastoma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01342757
Status
Completed

Conditions

  • Adult Glioblastoma
  • Depression
  • Recurrent Adult Brain Tumor

Eligibility Criteria

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

Interventions

  • vorinostat — DRUG
    Given orally
  • temozolomide — DRUG
    Given orally
  • magnetic resonance spectroscopic imaging — PROCEDURE
    Undergo MRI
  • survey administration — OTHER
    Ancillary studies

Study Details

This clinical trial is studying magnetic resonance spectroscopy imaging in predicting response in patients to vorinostat and temozolomide in patients with recurrent, progressive, or newly diagnosed glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help temozolomide work better by making tumor cells more sensitive to the drug. Imaging procedures, such as magnetic resonance spectroscopy imaging, may help measure the patient's response to vorinostat and temozolomide and allow doctors to plan better treatment.

Key Dates

Start date
Dec 31, 2010
Status verified
Jan 2018
Primary completion
May 31, 2012
Completion
May 31, 2012

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Arm I
    Patients receive vorinostat once daily on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance spectroscopic imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo a survey administration of Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study.

Primary Outcome Measure

Proportion of Patients With Magnetic Resonance Spectroscopy (MRS) Response to Initial Vorinostat by MRI and MRS Scans as Determined by Spectroscopic Index [ Time Frame: 9 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Emory University· Atlanta, GA

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