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

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Brief Title

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

Official Title

Using Proton Magnetic Resonance Spectroscopy (MRS) to Predict Response of Vorinostat Treatment in Glioblastoma

Brief Summary

      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.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To evaluate the strength of the association between magnetic resonance spectroscopy (MRS)
      imaging measurable biomarkers and response to vorinostat plus temozolomide.

      SECONDARY OBJECTIVES:

      I. To evaluate MRS-detected inositol and N-acetylaspartate (NAA) levels (at 3 tesla) as
      indicators of mood alterations as measured by a self-report depression survey (IDS-SR).

      OUTLINE:

      Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and
      days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the
      absence of disease progression or unacceptable toxicity. Patients previously treated with
      standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.

      Treatment repeats every 28 days in the absence of disease progression or unacceptable
      toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at
      approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression
      Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study.
    


Study Type

Interventional


Primary Outcome

Proportion of Patients With Magnetic Resonance Spectroscopy (MRS) Response to Initial Vorinostat by MRI and MRS Scans as Determined by Spectroscopic Index

Secondary Outcome

 Mean Change in Metabolite Levels

Condition

Adult Glioblastoma

Intervention

vorinostat

Study Arms / Comparison Groups

 Arm I
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

December 2010

Completion Date

May 2012

Primary Completion Date

May 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have 1 of the following:

               -  Diagnosis of recurrent or progressive glioblastoma

                    -  Patients with recurrent disease may have had treatment for any number of
                       prior relapses

               -  Newly diagnosed glioblastoma and have completed radiation therapy and are
                  receiving standard follow-up temozolomide

          -  Must be able to have an MRI, and have a measurable contrast-enhancing supratentorial
             tumor of at least 1 cm by shortest diameter

          -  Residual disease following resection measuring 1 cm in diameter or greater is mandated
             for eligibility into the study

          -  Patients must have a stable or progressive disease as determined by serial brain MRI
             using the McDonald Criteria on a scan 14 days or fewer before registration and on a
             stable steroid dose for 5 days

          -  Patients with prior therapy that included interstitial brachytherapy or stereotactic
             radiosurgery must have confirmation of true progressive disease rather than radiation
             necrosis based upon either positron emission tomography (PET) or thallium scanning, MR
             spectroscopy, or surgical documentation of disease

          -  White Blood Cell Count > 3,000/μL

          -  Absolute Neutrophil Count > 1,500/μL

          -  Platelet count > 100,000/μL

          -  Hemoglobin > 10 g/dL (transfusion allowed)

          -  Serum glutamate oxaloacetate transaminase < 2 times upper limit of normal (ULN)

          -  Bilirubin < 2 times ULN

          -  Creatinine < 1.5 mg/dL

          -  Negative pregnancy test

          -  Women of childbearing potential and men must agree to use adequate barrier
             contraception for the duration of study participation

          -  Able to swallow capsules

          -  No patients with pacemakers, non-titanium aneurysm clips, neurostimulators, cochlear
             implants, non-titanium metal in ocular structures, history of being a steel worker, or
             other incompatible implants

          -  No significant medical illnesses that, in the investigator's opinion, cannot be
             adequately controlled with appropriate therapy or would compromise the patient's
             ability to tolerate this therapy

          -  No history of any other cancer except non-melanoma skin cancer or carcinoma in-situ of
             the cervix, or cancer in complete remission and off all therapy for ≥ 3 years

          -  No active infection or serious intercurrent medical illness

          -  No disease that would obscure toxicity or dangerously alter drug metabolism

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to vorinostat (SAHA) or other agents used in this study

          -  No prolonged corrected QT interval waves on baseline EKG

          -  No other anticancer therapy (including chemotherapy, radiation, hormonal treatment, or
             immunotherapy) of any kind is permitted during the study period

          -  At least 3 weeks since prior radiotherapy

          -  Patients must have recovered from the toxic effects of prior therapy, including
             surgery

          -  At least 28 days since any prior investigational agent or prior cytotoxic therapy

          -  At least 23 days since prior temozolomide

          -  At least 14 days since prior vincristine (42 days for nitrosourea)

          -  At least 21 days since prior procarbazine

          -  At least 7 days since prior non-cytotoxic agents (e.g., interferon, tamoxifen,
             thalidomide, cis-retinoic acid, etc.)

          -  At least 2 weeks since prior valproic acid (or another histone deacetylase inhibitor)

          -  No other concurrent investigational agents

        Exclusion Criteria:

          -  Diagnostic and Statistical Manual-IV Axis I or II diagnosis (as determined by PI),
             exclusive of nicotine dependence.

          -  Pregnant.

          -  Contraindications to MRI: pacemaker, aneurysm clips, neurostimulators, cochlear
             implants, metal in eyes, steel worker, or other implants.

          -  Active medical or neurological disorder.

          -  History of alcohol or drug dependence
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jeffrey Olson, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01342757

Organization ID

NCI-2011-02569

Secondary IDs

EMORY IRB #00044064

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Jeffrey Olson, Principal Investigator, Emory University


Verification Date

January 2018