Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to see how well they work compared with each other when given together with radiation therapy followed by bevacizumab and temozolomide in treating young patients with newly diagnosed high-grade glioma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving vorinostat is more effective then temozolomide or bevacizumab when given together with radiation therapy in treating glioma.

Further Study Information

PRIMARY OBJECTIVES:

I. To identify the dose of vorinostat that is feasible when given in combination with radiotherapy (RT) in patients with newly diagnosed high-grade gliomas (HGG). II. To compare 1-year event-free survival of patients with newly diagnosed HGG treated with vorinostat (using MTD) versus bevacizumab versus temozolomide when given in combination with RT followed by maintenance therapy with bevacizumab and temozolomide. (Phase II) III. To compare the event-free survival of patients with newly diagnosed HGG treated with the superior chemoradiotherapy (from phase II portion) versus temozolomide given in combination with RT followed by maintenance chemotherapy with bevacizumab and temozolomide. (Phase III)

SECONDARY OBJECTIVES:

I. To evaluate the anti-tumor activity, as measured by event-free survival (EFS), progression-free survival (PFS), and overall survival (OS), of patients with newly diagnosed HGG treated with vorinostat, bevacizumab, or temozolomide when given in combination with RT followed by maintenance chemotherapy with bevacizumab and temozolomide. II. To define and evaluate the toxicities of each of the treatment arms of the study.

III. To conduct gene expression profiling and SNP arrays in patients with newly diagnosed HGG.

IV. To assess telomerase activity, hTert expression, and telomere length in patients with newly diagnosed HGG. V. To document changes in perfusion and diffusion using MR imaging at baseline, prior to, during (prior to course 3), and after maintenance therapy with bevacizumab and temozolomide.

VI. To correlate functional changes in tumor with responses to bevacizumab treatment using MR diffusion/perfusion imaging. VII. To correlate the results of the bevacizumab biology studies in serum or tumor with EFS.

VIII. To explore the prognostic significance of MGMT status for patients newly diagnosed with HGG treated with combined surgery, radiation, chemotherapy, and anti-angiogenic therapy.

OUTLINE: This is a multicenter, feasibility, dose-escalation study of vorinostat, followed by a phase II study, followed by a phase III study.

FEASIBILITY STUDY: Patients undergo 3-D conformal radiotherapy (RT) or intensity-modulated RT 5 days a week for 6 weeks. Patients also receive vorinostat orally (PO) once daily on days 1-5. Courses repeat every week for 6 weeks in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 4 weeks after completion of chemoradiotherapy, patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and temozolomide PO on days 1-5. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

PHASE II STUDY: Patients are stratified according to extent of resection (near total resection or gross total resection vs other) and histology (glioblastoma multiforme vs other). Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at the maximum-tolerated dose determined in the feasibility study.

ARM II: Patients undergo RT as in arm I and receive temozolomide PO once daily for 42 days beginning on day 5 of RT.

ARM III: Patients undergo RT as in arm I and receive bevacizumab IV over 30-90 minutes on days 22 and 36. Patients in all arms receive maintenance therapy as in the feasibility study.

PHASE III study: Patients are randomized to 1 of 2 treatment arms.

ARM IV: Patients receive RT and temozolomide as in phase II, arm II.

ARM V: Patients receive treatment as in phase II, arm I or phase II, arm III, whichever was established as the superior chemoradiotherapy arm in phase II. Patients in all arms receive maintenance therapy as in the feasibility study. Some patients undergo blood and tumor tissue sample (from surgery) collection for telomerase activity, hTert expression, telomere length, and gene expression profiling and SNP arrays analysis.

After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

Eligibility Criteria

Inclusion Criteria:

• Newly diagnosed high-grade glioma

• Anaplastic astrocytoma

• Glioblastomamultiforme

• Gliosarcoma

• Primary spinal cord malignant glioma allowed

• No oligodendroglioma oroligoastrocytoma

• Patient must have histological verification of diagnosis

• No M+ disease (defined as evidence of neuraxis dissemination)

• No positive CSF cytology

• ECOG performance status (PS) 0-2

• Karnofsky PS 50-100% (patients > 16 years of age)

• Lansky PS 50-100% (patients ≤ 16 years of age)

• ANC ≥ 1,000/μL

• Platelet count ≥ 100,000/μL

• Hemoglobin ≥ 8.0 mg/dL (transfusion independent)

• Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age and/or gender as follows:

• 0.4 mg/dL (1 month to < 6 months of age)

• 0.5 mg/dL (6 months to < 1 year of age)

• 0.6 mg/dL (1 to < 2 years of age)

• 0.8 mg/dL (2 to < 6 years of age)

• 1.0 mg/dL (6 to < 10 years of age)

• 1.2 mg/dL (10 to < 13 years of age)

• 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)

• 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)

• Proteinuria < 2+ OR urine; protein ratio (UPC) ≤ 0.5

• If UPC > 0.5, a 24-hour urine protein should be obtained and level should be < 1,000 mg of protein

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT < 2.5 times ULN

• Serum albumin ≥ 2 g/dL

• PT INR ≤ 1.5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during all study therapy and for ≥ 6 months after completion of bevacizumab

• Hypertension well controlled (≤ 95^th percentile for age and height if patient is ≤ 17years) by stable doses of medication allowed

• For patients > 17 years, systolic blood pressure (BP) ≤ 150 mm Hg or diastolic BP ≤ 100 mm Hg)

• Seizure disorder allowed provided patient is well-controlled and on nonenzyme-inducing anticonvulsants

• No history of myocardial infarction, severe or unstable angina, clinically significant peripheral vascular disease, ≥ grade 2 heart failure, or serious and inadequately controlled cardiac arrhythmia

• No known bleeding diathesis or coagulopathy

• No prior arterial thromboembolic events, including transient ischemic attacks orcerebrovascular accidents

• No prior diagnosis of a deep venous thrombosis, including pulmonary embolism, and no known thrombophilic condition (e.g., protein S, protein C, antithrombin III deficiency, Factor V Leiden or Factor II G202`0A mutation, homocysteinemia, or antiphospholipid antibody syndrome)

• No history of an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months

• No serious or non-healing wound, ulcer, or bone fracture

• No evidence of significant postoperative intracranial hemorrhage, defined as > 1 cm of blood on postoperative MRI scan (potentially in addition to the postoperative scan) obtained within the past 14days

• No history of allergic reaction to Chinese hamster ovary cell products or other recombinanthuman antibodies

• No more than 31 days since definitive surgery

• Must not have received any prior chemotherapy, radiotherapy, immunotherapy, or bone marrow transplant

• More than 7 days since major surgical procedure and recovered

• For patients scheduled to receive bevacizumab:

• More than 28 days since major procedure

• More than 14 days since intermediate procedure

• More than 7 days since minor procedure (lumbar picture or placement of PICC lines are not considered minor procedures)

• No other current anti-cancer agents

• No concurrent nonsteroidal anti-inflammatory medications known to inhibit platelet function or known to selectively inhibit cyclooxygenase activity

• No concurrent enzyme inducing anticonvulsants

• No concurrent HDAC inhibitors (e.g., valproic acid)

• No concurrent anticoagulants including systemic thrombolytic agents, heparin, low molecular weight heparins, or warfarin except as required to maintain patency of pre-existing permanent vascular catheters or for prevention of thrombosis in the post-operative period

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Maryam Fouladi

Principal Investigator

U.S.A.
Alabama
	Birmingham
	Children's Hospital of Alabama at University of Alabama at Birmingham
		Alyssa T Reddy	Ph: 205-934-0309
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		David L Becton	Ph: 501-364-7373
California
	Downey
	Southern California Permanente Medical Group
		Robert M Cooper	Ph: 626-564-3455
	Loma Linda
	Loma Linda University Cancer Institute at Loma Linda University Medical Center
		Antranik A Bedros	Ph: 909-558-3375
	Long Beach
	Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
		Jerry Z Finklestein	Ph: 562-933-5437
	Los Angeles
	Childrens Hospital Los Angeles
		Leo Mascarenhas	Ph: 323-361-4110
	Mattel Children's Hospital at UCLA
		Tom B Davidson	Ph: 310-825-6708
	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
		Carole H Hurvitz	Ph: 310-423-8965
	Madera
	Children's Hospital Central California
		Vonda L Crouse	Ph: 866-353-5437
	Oakland
	Children's Hospital and Research Center Oakland
		Joseph C Torkildson	Ph: 510-450-7600
	Orange
	Children's Hospital of Orange County
		Violet Shen	Ph: 714-997-3000
	Palo Alto
	Lucile Packard Children's Hospital at Stanford University Medical Center
		Neyssa M Marina	Ph: 650-498-7061
			Email: clinicaltrials@med.stanford.edu
	San Diego
	Rady Children's Hospital - San Diego
		William D Roberts	Ph: 858-966-5934
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Anuradha Banerjee	Ph: 877-827-3222
Connecticut
	Hartford
	Connecticut Children's Medical Center
		Michael S Isakoff	Ph: 860-545-9981
	New Haven
	Yale Cancer Center
		Nina S Kadan-Lottick	Ph: 203-785-5702
Delaware
	Wilmington
	Alfred I. duPont Hospital for Children
		Christopher N Frantz	Ph: 302-651-5755
District of Columbia
	Washington
	Children's National Medical Center
		Jeffrey S Dome	Ph: 202-884-2549
Florida
	Fort Myers
	Lee Cancer Care of Lee Memorial Health System
		Emad K Salman	Ph: 239-343-5333
	Jacksonville
	Nemours Children's Clinic
		Eric S Sandler	Ph: 904-697-3529
	Miami
	Miami Children's Hospital
		Enrique A Escalon	Ph: 305-662-8360
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		Julio C Barredo	Ph: 866-574-5124
			Email: Sylvester@emergingmed.com
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clifford A Selsky	Ph: 407-303-5623
	M.D. Anderson Cancer Center at Orlando
		Vincent F Giusti	Ph: 321-841-7246
	Nemours Children's Clinic - Orlando
		Ramamoorthy Nagasubramanian	Ph: 407-650-7150
	Pensacola
	Nemours Children's Clinic - Pensacola
		Jeffrey H Schwartz	Ph: 904-697-3529
	Saint Petersburg
	All Children's Hospital
		Gregory A Hale	Ph: 727-767-2423
			Email: HamblinF@allkids.org
	Tampa
	St. Joseph's Children's Hospital of Tampa
		Hardeo K Panchoosingh	Ph: 800-882-4123
Georgia
	Atlanta
	AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
		Howard M Katzenstein	Ph: 888-785-1112
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		J. Martin Johnston	Ph: 912-350-8568
Hawaii
	Honolulu
	Cancer Research Center of Hawaii
		Robert W Wilkinson	Ph: 808-983-6090
Illinois
	Chicago
	Ann and Robert H. Lurie Children's Hospital of Chicago
		Stewart Goldman	Ph: 773-880-4562
	University of Chicago Cancer Research Center
		Susan L Cohn	Ph: 773-834-7424
	University of Illinois Cancer Center
		Mary L Schmidt	Ph: 312-355-3046
	Peoria
	Saint Jude Midwest Affiliate
		Pedro A De Alarcon	Ph: 309-655-3258
	Springfield
	Simmons Cooper Cancer Institute
		Gregory P Brandt	Ph: 217-545-7929
Indiana
	Indianapolis
	Riley's Children Cancer Center at Riley Hospital for Children
		Robert J Fallon	Ph: 317-274-2552
	St. Vincent Indianapolis Hospital
		Bassem I Razzouk	Ph: 317-338-2194
Iowa
	Des Moines
	Blank Children's Hospital
		Wendy L Woods-Swafford	Ph: 888-823-5923
			Email: ctsucontact@westat.com
Kentucky
	Lexington
	University of Kentucky Chandler Medical Center
		Martha F Greenwood	Ph: 859-257-3379
	Louisville
	Kosair Children's Hospital
		Salvatore J Bertolone	Ph: 866-530-5516
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Kenneth J Cohen	Ph: 410-955-8804
			Email: jhcccro@jhmi.edu
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
		Carlos Rodriguez-Galindo	Ph: 866-790-4500
	Floating Hospital for Children at Tufts - New England Medical Center
		Johannes E Wolff	Ph: 617-636-5000
			Email: ContactUsCancerCenter@TuftsMedicalCenter.org
Michigan
	Detroit
	Wayne State University
		Maxim Y Yankelevich	Ph: 313-576-9363
	Grand Rapids
	Helen DeVos Children's Hospital at Spectrum Health
		David S Dickens	Ph: 616-267-1925
	Kalamazoo
	Bronson Methodist Hospital
		Jeffrey S Lobel	Ph: 800-227-2345
	Lansing
	Breslin Cancer Center at Ingham Regional Medical Center
		Renuka Gera	Ph: 517-334-2765
Minnesota
	Minneapolis
	Children's Hospitals and Clinics of Minnesota - Minneapolis
		Bruce C Bostrom	Ph: 612-813-5193
	Rochester
	Mayo Clinic Cancer Center
		Amulya A Nageswara Rao	Ph: 507-538-7623
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Betty L Herrington	Ph: 601-815-6700
Missouri
	Kansas City
	Children's Mercy Hospital
		Maxine L Hetherington	Ph: 816-234-3265
	Saint Louis
	Cardinal Glennon Children's Hospital
		William S Ferguson	Ph: 314-268-4000
	David C. Pratt Cancer Center at St. John's Mercy
		Bethany G. Sleckman	Ph: 913-948-5588
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Joshua B Rubin	Ph: 800-600-3606
			Email: info@siteman.wustl.edu
Nebraska
	Omaha
	Children's Hospital
		Minnie Abromowitch	Ph: 402-955-3949
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Peter F Coccia	Ph: 800-999-5465
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		Jonathan Bernstein	Ph: 702-384-0013
New Jersey
	Hackensack
	Hackensack University Medical Center Cancer Center
		Burton E Appel	Ph: 201-996-2879
	Morristown
	Carol G. Simon Cancer Center at Morristown Memorial Hospital
		Steven L Halpern	Ph: 973-971-5900
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Richard A Drachtman	Ph: 732-235-8675
	Paterson
	St. Joseph's Hospital and Medical Center
		Mary A Bonilla	Ph: 973-754-2909
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Koh B Boayue	Ph: 505-272-6972
New York
	Albany
	Albany Medical Center Hospital
		Vikramjit S Kanwar	Ph: 518-262-3368
	Bronx
	Montefiore Medical Center
		Rosanna J Ricafort	Ph: 718-904-2730
			Email: aecc@aecom.yu.edu
	Buffalo
	Roswell Park Cancer Institute
		Martin L Brecher	Ph: 877-275-7724
	New Hyde Park
	Schneider Children's Hospital
		Arlene S Redner	Ph: 718-470-3470
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Alice Lee	Ph: 212-305-8615
	Memorial Sloan-Kettering Cancer Center
		Peter G Steinherz	Ph: 212-639-7202
	New York University Medical Center
		Jeffrey C Allen	Ph: 212-263-4434
			Email: prmc.coordinator@nyumc.org
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Jeffrey R Andolina	Ph: 585-275-5830
	Syracuse
	SUNY Upstate Medical University Hospital
		Karol H Kerr	Ph: 315-464-5476
	Valhalla
	New York Medical College
		Mehmet F Ozkaynak	Ph: 914-594-3794
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Stuart H Gold	Ph: 877-668-0683
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Joel A Kaplan	Ph: 704-355-2884
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Thomas W McLean	Ph: 336-713-6771
North Dakota
	Fargo
	Roger Maris Cancer Center at MeritCare Hospital
		Nathan L Kobrinsky	Ph: 701-234-6161
Ohio
	Akron
	Akron Children's Hospital
		Steven J Kuerbitz	Ph: 330-543-3193
	Cincinnati
	Cincinnati Children's Hospital Medical Center
		John P Perentesis	Ph: 513-636-2799
	Cleveland
	Seidman Cancer Center at University Hospitals/Case Medical Center
		Yousif (Joe) H Matloub	Ph: 216-844-5437
	Columbus
	Nationwide Children's Hospital
		Laura T Martin	Ph: 614-722-2708
	Dayton
	Dayton Children's - Dayton
		Emmett H Broxson	Ph: 800-228-4055
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Rene Y McNall-Knapp	Ph: 405-271-4272
			Email: julie-traylor@ouhsc.edu
Oregon
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Linda C. Stork	Ph: 503-494-1080
			Email: trials@ohsu.edu
Pennsylvania
	Bethlehem
	Lehigh Valley Hospital - Muhlenberg
		Philip M Monteleone	Ph: 484-884-2201
	Hershey
	Penn State Children's Hospital
		Lisa M McGregor	Ph: 717-531-6012
	Philadelphia
	Children's Hospital of Philadelphia
		Frank M Balis	Ph: 215-590-2810
	Pittsburgh
	Children's Hospital of Pittsburgh of UPMC
		Arthur K Ritchey	Ph: 412-692-5573
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Jacqueline M Kraveka	Ph: 843-792-9321
	Columbia
	Palmetto Health South Carolina Cancer Center
		Ronnie W. Neuberg	Ph: 803-434-3680
	Greenville
	BI-LO Charities Children's Cancer Center
		Nichole L Bryant	Ph: 864-241-6251
South Dakota
	Sioux Falls
	Sanford Cancer Center at Sanford USD Medical Center
		Kayelyn J Wagner	Ph: 605-328-1367
Tennessee
	Knoxville
	East Tennessee Children's Hospital
		Ray C Pais	Ph: 865-541-8266
	Memphis
	St. Jude Children's Research Hospital
		Alberto Broniscer	Ph: 901-595-4644
	Nashville
	Vanderbilt-Ingram Cancer Center
		Adam Esbenshade	Ph: 800-811-8480
Texas
	Austin
	Dell Children's Medical Center of Central Texas
		Sharon K Lockhart	Ph: 512-324-8022
	Corpus Christi
	Driscoll Children's Hospital
		M. Cris Johnson	Ph: 361-694-5311
	Fort Worth
	Cook Children's Medical Center - Fort Worth
		Mary Meaghan P Granger	Ph: 682-885-2103
	Houston
	Dan L. Duncan Cancer Center at Baylor College of Medicine
		Jack M. Su	Ph: 713-798-1354
			Email: burton@bcm.edu
	San Antonio
	Methodist Children's Hospital of South Texas
		Jaime Estrada	Ph: 210-575-7000
	University of Texas Health Science Center at San Antonio
		Anne-Marie R Langevin	Ph: 210-567-0653
			Email: che@uthscsa.edu
	Temple
	Scott and White Cancer Institute
		Guy H Grayson	Ph: 254-724-5407
Utah
	Salt Lake City
	Primary Children's Medical Center
		Phillip E Barnette	Ph: 801-585-5270
Virginia
	Portsmouth
	Naval Medical Center - Portsmouth
		Brian L Feldman	Ph: 757-953-5939
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Asadullah Khan	Ph: 804-628-1939
Washington
	Seattle
	Children's Hospital and Regional Medical Center - Seattle
		Jeffrey R Geyer	Ph: 866-987-2000
	Spokane
	Providence Cancer Center at Sacred Heart Medical Center
		Judy L Felgenhauer	Ph: 800-228-6618
			Email: HopeBeginsHere@providence.org
	Tacoma
	Mary Bridge Children's Hospital and Health Center - Tacoma
		Robert G Irwin	Ph: 888-823-5923
			Email: ctsucontact@westat.com
West Virginia
	Charleston
	West Virginia University Medical School - Charleston
		Allen R Chauvenet	Ph: 304-388-9944
Wisconsin
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Kenneth B De Santes	Ph: 608-262-5223
	Marshfield
	Marshfield Clinic - Marshfield Center
		Michael J McManus	Ph: 715-389-4457
	Milwaukee
	Midwest Children's Cancer Center at Children's Hospital of Wisconsin
		Michael E Kelly	Ph: 414-805-4380
Canada
British Columbia
	Vancouver
	Children's and Women's Hospital of British Columbia
		Caron Strahlendorf	Ph: 604-875-2345ext6477
Manitoba
	Winnipeg
	CancerCare Manitoba
		Rochelle A Yanofsky	Ph: 866-561-1026
			Email: CIO_Web@cancercare.mb.ca
Nova Scotia
	Halifax
	IWK Health Centre
		Margaret C Yhap	Ph: 902-470-8394
Ontario
	Toronto
	Hospital for Sick Children
		Ronald M Grant	Ph: 416-813-7654ext2027
			Email: jason.mcguire@sickkids.ca
Quebec
	Montreal
	Hopital Sainte Justine
		Yvan Samson	Ph: 514-345-4931
	Montreal Children's Hospital at McGill University Health Center
		Sharon B Abish	Ph: 514-412-4445
			Email: info@thechildren.com
	Ste-Foy
	Centre de Recherche du Centre Hospitalier de l'Universite Laval
		Bruno Michon	Ph: 418-525-4444
Saskatchewan
	Saskatoon
	Saskatoon Cancer Centre at the University of Saskatchewan
		Christopher Mpofu	Ph: 306-655-2914

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01236560
Information obtained from ClinicalTrials.gov on May 05, 2013

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