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

Basic Trial Information

Trial Description

Summary

This phase II/III trial is studying lenalidomide to see how well it works compared to observation in treating patients with asymptomatic high-risk smoldering multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient.

Further Study Information

PRIMARY OBJECTIVES:

I. Study the risk of grade 3-4 non-hematologic adverse events in patients with asymptomatic high-risk smoldering multiple myeloma treated with lenalidomide. (Phase II) II. Compare the progression-free survival (PFS) of patients with asymptomatic high-risk smoldering multiple myeloma treated with lenalidomide versus observation alone. (Phase III)

SECONDARY OBJECTIVES:

I. Assess the response of patients treated with lenalidomide. (Phase II) II. Determine and compare the response rate, time to progression, 1-year PFS probability, and the overall survival of patients treated with lenalidomide versus observation alone. (Phase III) III. Estimate the incidence of adverse events of these regimens in these patients. (Phase III)

TERTIARY OBJECTIVES:

I. Describe the cohort in terms of GEP and cytogenetic risk classification and evaluate baseline immune and MRI parameters. (Phase II) II. Evaluate the impact of therapy within GEP-defined risk groups and GEP as a prognostic marker. (Phase III) III. Study the effects of lenalidomide on laboratory markers of immune function. (Phase III) IV. Study the prognostic value of MRI-detected asymptomatic bone disease on clinical outcome. (Phase III V. Evaluate the prognostic effect of baseline high-risk cytogenetic abnormalities on clinical outcome. (Phase III)

QUATERNARY OBJECTIVES:

I. To compare QOL change between treatment and observation arms based on the functional (FWB) and physical (PWB) well-being components of the FACT-General (G) patient-reported outcome (PRO) measure from registration (prior to initiation of treatment) up to cycle 24.

II. To examine the impact of differential treatment response (PFS), if observed, on QOL based on the FACT FWB+PWB up to cycle 48.

III. To obtain prospective data on Myeloma specific QOL attributes, utilizing and evaluating the Multiple Myeloma Subscale (MMS).

OUTLINE: This is a multicenter study.

PHASE II: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

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

ARM I: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive standard of care and undergo observation in the absence of disease progression.

Peripheral blood, bone marrow aspirate, and bone marrow core biopsy samples are collected for gene expression profiling, immune function, and cytogenetic abnormalities. Patients complete the Functional Assessment of Cancer Therapy (FACT) Physical Well-Being (PWB), and FACT Functional Well-Being (FWB) questionnaires at baseline and periodically during study.

After completion of study therapy, patients are followed up periodically for 10 years.

Eligibility Criteria

Inclusion Criteria:

• Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months, as confirmed by both of the following:

• Bone marrow plasmacytosis with >= 10% plasma cells or sheet of plasma cells which must be obtained by bone marrow aspiration and/or biopsy within 4 weeks prior to randomization

• Abnormal serum free-light chain (FLC) ratio (< 0.125 or > 8.0) by serum FLC assay; FLC assay must be performed within 28 days of randomization

• Measurable monoclonal protein in the serum >= 1.0 g/dL or urine >= 200 mg/24 hrs

• No lytic lesions on skeletal surveys and no hypercalcemia (i.e., >= 11 mg/dL)

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Absolute neutrophil count (ANC) > 1,500/mm³

• Platelet count > 100,000/mm³

• Hemoglobin > 11 g/dL

• Creatinine clearance > 30 mL/min

• Bilirubin < 1.5 mg/dL

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times upper limit of normal

• More than 6 months since active, uncontrolled seizure disorder

• Willing to take some form of anti-coagulation as prophylaxis if there is a history of or concurrent deep vein thrombosis or pulmonary embolism

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use 2 effective methods of contraception for ≥ 28 days before, during, and ≥ 28 days after completion of study therapy

• Prior malignancy allowed provided treatment of curative intent was delivered and disease-free for time period considered appropriate for the specific cancer

• Human immunodeficiency virus (HIV)-positive patients allowed provided the following criteria are met:

• CD4 cell count >= 350/mm³

• No history of acquired immunodeficiency syndrome (AIDS)-related illness

• No uncontrolled intercurrent illness including any of the following:

• Uncontrolled hypertension

• Symptomatic congestive heart failure

• Unstable angina

• Uncontrolled cardiac arrhythmia

• Uncontrolled psychiatric illness or social situation that would limit compliance with the study

• Prior Stevens Johnson Syndrome

• No peripheral neuropathy >= grade 2

• No active uncontrolled infection

• No New York Heart Association (NYHA) class III or IV heart failure

• No prior or concurrent systemic therapy or radiotherapy for MM

• No prior or concurrent erythropoietin

• No prior glucocorticosteroid for MM

• Prior systemic glucocorticosteroid for non-malignant disorders allowed (prednisone equivalent ≤ 10 mg/day)

• Prior or concurrent topical or localized glucocorticosteroid to treat non-malignant comorbid disorders allowed

• No concurrent bisphosphonates

• Prior bisphosphonates or once-a-year intravenous bisphosphonate for osteoporosis allowed

• No concurrent zidovudine or stavudine for HIV-positive patients

• No concurrent chemotherapy including cyclophosphamide and stem cell mobilization

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Sagar Lonial

Principal Investigator

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		John A Lust	Ph: 507-538-7623
California
	Mountain View
	Palo Alto Medical Foundation
		Peter P. Yu	Ph: 650-934-7000
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Edward W. Nelson	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	Palo Alto
	Palo Alto Medical Foundation
		David S Leibowitz	Ph: 650-853-2906
			Email: waldorj@pamf.org
Colorado
	Aurora
	Medical Center of Aurora - South Campus
		Eduardo R. Pajon	Ph: 888-785-6789
	Boulder
	Boulder Community Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Denver
	CCOP - Colorado Cancer Research Program
		Eduardo R. Pajon	Ph: 888-785-6789
	Porter Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Presbyterian - St. Luke's Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Rose Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	St. Anthony Central Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	St. Joseph Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Englewood
	Swedish Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Grand Junction
	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
		Virginia M Tjan-Wettstein	Ph: 970-298-7500
	Greeley
	North Colorado Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Littleton
	Littleton Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Lone Tree
	Sky Ridge Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Longmont
	Hope Cancer Care Center at Longmont United Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Loveland
	McKee Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Parker
	Parker Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Pueblo
	St. Mary - Corwin Regional Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Thornton
	North Suburban Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Wheat Ridge
	Exempla Lutheran Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
Connecticut
	Danbury
	Praxair Cancer Center at Danbury Hospital
		Marc G Rappaport	Ph: 203-739-8074
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Christopher M Reynolds	Ph: 734-712-3456
	Manchester
	Manchester Memorial Hospital
		Michael A Reale	Ph: 860-533-4000
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		Brian J Byrne	Ph: 860-224-5660
	Norwich
	Eastern Connecticut Hematology and Oncology Associates
		Dennis E. Slater	Ph: 860-886-8362
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Gregory A. Masters	Ph: 302-733-6227
	Newark
	Helen F. Graham Cancer Center at Christiana Hospital
		Gregory A. Masters	Ph: 302-733-6227
Florida
	Hollywood
	Joe DiMaggio Children's Hospital
		Neil Nagovski	Ph: 888-823-5923
			Email: ctsucontact@westat.com
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Michael Schwartz	Ph: 305-674-2625
			Email: info@msccop.com
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Michael Schwartz	Ph: 305-674-2625
			Email: info@msccop.com
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Lee M. Zehngebot	Ph: 407-303-5623
Georgia
	Albany
	Phoebe Cancer Center at Phoebe Putney Memorial Hospital
		Jose M. Tongol	Ph: 229-312-2251
	Atlanta
	Northside Hospital Cancer Center
		Thomas E. Seay	Ph: 404-303-3355
	Winship Cancer Institute of Emory University
		Sagar Lonial	Ph: 404-778-1868
	Augusta
	Medical College of Georgia Cancer Center
		Anand P. Jillella	Ph: 706-721-1663
			Email: cancer@georgiahealth.edu
Illinois
	Bloomington
	Illinois CancerCare - Bloomington
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Canton
	Illinois CancerCare - Canton
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Carthage
	Illinois CancerCare - Carthage
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Chicago
	Creticos Cancer Center at Advocate Illinois Masonic Medical Center
		Denise Angelique Levitan	Ph: 336-713-6771
	University of Illinois Cancer Center
		Pritesh Patel	Ph: 312-355-3046
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		James L. Wade	Ph: 217-876-4740
			Email: kcheek@dmhhs.org
	Eureka
	Illinois CancerCare - Eureka
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Galesburg
	Galesburg Clinic, PC
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Havana
	Illinois CancerCare - Havana
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Kewanee
	Illinois CancerCare - Kewanee Clinic
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Macomb
	Illinois CancerCare - Macomb
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Monmouth
	Illinois CancerCare - Monmouth
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Normal
	Illinois CancerCare - Community Cancer Center
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Ottawa
	Illinois CancerCare - Ottawa
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Pekin
	Illinois CancerCare - Pekin
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Peoria
	CCOP - Illinois Oncology Research Association
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Illinois CancerCare - Peoria
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Peru
	Illinois CancerCare - Princeton
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Princeton
	Illinois CancerCare - Princeton
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Rockford
	Swedish-American Regional Cancer Center
		Harvey Eric Einhorn	Ph: 815-489-4413
	Springfield
	Regional Cancer Center at Memorial Medical Center
		James L. Wade	Ph: 217-876-4740
			Email: kcheek@dmhhs.org
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard M. Gross	Ph: 765-983-3000
	Lafayette
	Clarian Arnett Cancer Care
		Thomas Isaac Jones	Ph: 800-899-8448ext7431
			Email: sstidham@clarianarnett.com
	Richmond
	Reid Hospital & Health Care Services
		Howard M. Gross	Ph: 765-983-3000
Iowa
	Ames
	McFarland Clinic, PC
		Joseph James Merchant	Ph: 515-239-2621
	Sioux City
	Siouxland Hematology-Oncology Associates, LLP
		Donald Bruce Wender	Ph: 712-252-0088
Kansas
	Wichita
	Wesley Medical Center
		Shaker R. Dakhil	Ph: 316-262-4467
Louisiana
	Baton Rouge
	Ochsner Health Center - Bluebonnet
		Arthur Molina	Ph: 888-562-4763
	Covington
	Ochsner Health Center - Covington
		Arthur Molina	Ph: 888-562-4763
	New Orleans
	Ochsner Cancer Institute at Ochsner Clinic Foundation
		Arthur Molina	Ph: 888-562-4763
Maryland
	Bethesda
	National Naval Medical Center
		David C Van Echo	Ph: 301-319-2100
	Elkton MD
	Union Hospital of Cecil County
		Gregory A. Masters	Ph: 302-733-6227
Massachusetts
	Boston
	Eastern Cooperative Oncology Group
		Sagar Lonial	Ph: 404-727-5671
			Email: sloni01@emory.edu
Michigan
	Ann Arbor
	Saint Joseph Mercy Cancer Center
		Christopher M Reynolds	Ph: 734-712-3456
	Flint
	Genesys Hurley Cancer Institute
		Christopher M Reynolds	Ph: 734-712-3456
	Kalamazoo
	West Michigan Cancer Center
		Raymond Sterling Lord	Ph: 269-373-7458
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Christopher M Reynolds	Ph: 734-712-3456
	Southfield
	Providence Hospital - Southfield
		Howard R. Terebelo	Ph: 248-849-5337
			Email: jaswinder.grewal@stjohn.org
Minnesota
	Burnsville
	Fairview Ridges Hospital
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Duluth
	CCOP - Duluth
		Daniel Nikcevich	Ph: 888-203-7267
	Edina
	Fairview Southdale Hospital
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Hutchinson
	Hutchinson Area Health Care
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minnesota Oncology - Maplewood
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Robbinsdale
	Humphrey Cancer Center at North Memorial Outpatient Center
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Rochester
	Mayo Clinic Cancer Center
		John A Lust	Ph: 507-538-7623
	Saint Louis Park
	CCOP - Metro-Minnesota
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Park Nicollet Cancer Center
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Saint Paul
	Regions Hospital Cancer Care Center
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	United Hospital
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Stillwater
	Lakeview Hospital
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Waconia
	Ridgeview Medical Center
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Willmar
	Willmar Cancer Center at Rice Memorial Hospital
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Woodbury
	Minnesota Oncology - Woodbury
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Stephanie L Elkins	Ph: 601-815-6700
Missouri
	Kansas City
	Veterans Affairs Medical Center - Kansas City
		Suman Kambhampati	Ph: 800-525-1483
	Saint Louis
	Missouri Baptist Cancer Center
		Alan Philip Lyss	Ph: 800-392-0936
Montana
	Billings
	Billings Clinic Cancer Center - 801 N 29th Street
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
Nebraska
	Lincoln
	Cancer Resource Center - Lincoln
		Gamini S. Soori	Ph: 800-253-4368
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Allan Ellerton	Ph: 702-731-8274
New Jersey
	Camden
	Cancer Institute of New Jersey at Cooper University Hospital - Camden
		Gregory A. Masters	Ph: 302-733-6227
	East Orange
	Veterans Affairs Medical Center - East Orange
		Basil S. Kasimis	Ph: 800-475-2336
			Email: patricia.goyer@med.va.gov
	Newark
	Newark Beth Israel Medical Center
		Lori Schleicher	Ph: 973-926-7230
New York
	Bronx
	Jack D. Weiler Hospital at Montefiore Medical Center - East Campus
		Stefan K Barta	Ph: 718-904-2730
			Email: aecc@aecom.yu.edu
	Montefiore Medical Center
		Stefan K Barta	Ph: 718-904-2730
			Email: aecc@aecom.yu.edu
North Carolina
	Kinston
	Kinston Medical Specialists
		Peter R. Watson	Ph: 252-559-2200
	Statesville
	Iredell Memorial Hospital
		Ruby A. Grimm	Ph: 704-873-5661
North Dakota
	Bismarck
	Bismarck Cancer Center
		John T Reynolds	Ph: 701-323-5760
			Email: tfischer@mohs.org
	Medcenter One Hospital Cancer Care Center
		John T Reynolds	Ph: 701-323-5760
			Email: tfischer@mohs.org
	Mid Dakota Clinic, PC
		John T Reynolds	Ph: 701-323-5760
			Email: tfischer@mohs.org
Ohio
	Cleveland
	Case Comprehensive Cancer Center
		Erica L Campagnaro	Ph: 800-641-2422
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce J. Averbook	Ph: 216-778-8526
			Email: kbauchens@metrohealth.org
	Columbus
	CCOP - Columbus
		J. Philip Kuebler	Ph: 614-566-3275
	Mount Carmel Health - West Hospital
		J. Philip Kuebler	Ph: 614-566-3275
	Riverside Methodist Hospital Cancer Care
		J. Philip Kuebler	Ph: 614-566-3275
	Zangmeister Center
		J. Philip Kuebler	Ph: 614-566-3275
	Dayton
	CCOP - Dayton
		Howard M. Gross	Ph: 765-983-3000
	David L. Rike Cancer Center at Miami Valley Hospital
		Howard M. Gross	Ph: 765-983-3000
	Good Samaritan Hospital
		Howard M. Gross	Ph: 765-983-3000
	Grandview Hospital
		Howard M. Gross	Ph: 765-983-3000
	Samaritan North Cancer Care Center
		Howard M. Gross	Ph: 765-983-3000
	Findlay
	Blanchard Valley Regional Cancer Center
		Howard M. Gross	Ph: 765-983-3000
	Franklin
	Atrium Medical Center
		Howard M. Gross	Ph: 765-983-3000
	Greenville
	Wayne Hospital
		Howard M. Gross	Ph: 765-983-3000
	Kettering
	Charles F. Kettering Memorial Hospital
		Howard M. Gross	Ph: 765-983-3000
	Lima
	St. Rita's Medical Center
		Henry Gerad	Ph: 419-226-9617
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler	Ph: 614-566-3275
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler	Ph: 614-566-3275
	Troy
	UVMC Cancer Care Center at Upper Valley Medical Center
		Howard M. Gross	Ph: 765-983-3000
	Westerville
	Mount Carmel St. Ann's Cancer Center
		J. Philip Kuebler	Ph: 614-566-3275
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard M. Gross	Ph: 765-983-3000
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Carla Kurkjian	Ph: 405-271-4272
			Email: julie-traylor@ouhsc.edu
Oregon
	Milwaukie
	Providence Milwaukie Hospital
		Alison K Conlin	Ph: 503-215-6412
	Newberg
	Providence Newberg Medical Center
		Alison K Conlin	Ph: 503-215-6412
	Oregon City
	Willamette Falls Hospital
		Alison K Conlin	Ph: 503-215-6412
	Portland
	Providence Cancer Center at Providence Portland Medical Center
		Alison K Conlin	Ph: 503-215-6412
	Providence St. Vincent Medical Center
		Alison K Conlin	Ph: 503-215-6412
Pennsylvania
	Bryn Mawr
	Bryn Mawr Hospital
		Paul B. Gilman	Ph: 484-476-2649
			Email: wellenbachj@mlhs.org
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Edward J Gorak	Ph: 570-271-5251
	Paoli
	Cancer Center of Paoli Memorial Hospital
		Paul B. Gilman	Ph: 484-476-2649
			Email: wellenbachj@mlhs.org
	Philadelphia
	Joan Karnell Cancer Center at Pennsylvania Hospital
		Lee Hartner	Ph: 800-789-7366
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		Edward J Gorak	Ph: 570-271-5251
	Williamsport
	Susquehanna Cancer Center at Divine Providence Hospital
		Warren L Robinson	Ph: 800-598-4282
	Wynnewood
	Lankenau Cancer Center at Lankenau Hospital
		Paul B. Gilman	Ph: 484-476-2649
			Email: wellenbachj@mlhs.org
South Carolina
	Charleston
	Roper St. Francis Cancer Center at Roper Hospital
		James Michael Orcutt	Ph: 843-720-8386
			Email: elizabeth.strojny@roperstfrancis.com
	Easley
	Cancer Centers of the Carolinas - Easley
		Jeffrey Kent Giguere	Ph: 864-241-6251
	Greenville
	Cancer Centers of the Carolinas - Faris Road
		Jeffrey Kent Giguere	Ph: 864-241-6251
	Cancer Centers of the Carolinas - Grove Commons
		Jeffrey Kent Giguere	Ph: 864-241-6251
	CCOP - Greenville
		Jeffrey Kent Giguere	Ph: 864-241-6251
	Greenville Memorial Hospital
		Jeffrey Kent Giguere	Ph: 864-241-6251
	Greer
	Cancer Centers of the Carolinas - Greer Medical Oncology
		Jeffrey Kent Giguere	Ph: 864-241-6251
	Seneca
	Cancer Centers of the Carolinas - Seneca
		Jeffrey Kent Giguere	Ph: 864-241-6251
	Spartanburg
	Cancer Centers of the Carolinas - Spartanburg
		Jeffrey Kent Giguere	Ph: 864-241-6251
South Dakota
	Aberdeen
	Conklin Regional Cancer Center
		Richard J. Conklin	Ph: 605-622-5613
	Rapid City
	Rapid City Regional Hospital
		Mark T Schroeder	Ph: 605-716-3982
			Email: research@rcrh.org
	Sioux Falls
	Avera Cancer Institute
		Addison R Tolentino	Ph: 800-657-4377
			Email: Jan.Healy@avera.org
Tennessee
	Jackson
	West Tennessee Cancer Center at Jackson-Madison County General Hospital
		Salomon Asmar	Ph: 731-425-6865
	Knoxville
	U.T. Medical Center Cancer Institute
		Wahid T. Hanna	Ph: 865-544-9773
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Thomas W Froehlich	Ph: 214-648-7097
Vermont
	Rutland
	Community Cancer Center at Rutland Regional Medical Center
		Allan D. Eisemann	Ph: 802-775-7111
Washington
	Vancouver
	Southwest Washington Medical Center Cancer Center
		Alison K Conlin	Ph: 503-215-6412
Wisconsin
	Chippewa Falls
	Marshfield Clinic - Chippewa Center
		Matthias Weiss	Ph: 800-347-0673
	Eau Claire
	Marshfield Clinic Cancer Care at Regional Cancer Center
		Matthias Weiss	Ph: 800-347-0673
	Green Bay
	Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
		Dhimant R. Patel	Ph: 800-252-2990
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Kurt Oettel	Ph: 608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	Dean Hematology & Oncology Clinic
		Amit Sanyal	Ph: 608-410-2700
	Marinette
	Vince Lombardi Cancer Clinic - Marinette
		Dhimant R. Patel	Ph: 800-252-2990
	Marshfield
	Marshfield Clinic - Marshfield Center
		Matthias Weiss	Ph: 800-347-0673
	Mequon
	Columbia Saint Mary's Hospital - Ozaukee
		Charles H. I. Tiber	Ph: 414-326-2675
			Email: clinicaltrials@columbia-stmarys.org
	Milwaukee
	Columbia-Saint Mary's Cancer Care Center
		Charles H. I. Tiber	Ph: 414-326-2675
			Email: clinicaltrials@columbia-stmarys.org
	Minocqua
	Marshfield Clinic - Lakeland Center
		Matthias Weiss	Ph: 800-347-0673
	Oconomowoc
	Regional Cancer Center at Oconomowoc Memorial Hospital
		Michael A Thompson	Ph: 262-928-7632
	Rhinelander
	Ministry Medical Group at Saint Mary's Hospital
		Matthias Weiss	Ph: 800-347-0673
	Rice Lake
	Marshfield Clinic - Indianhead Center
		Matthias Weiss	Ph: 800-347-0673
	Stevens Point
	Marshfield Clinic at Saint Michael's Hospital
		Matthias Weiss	Ph: 800-347-0673
	Summit
	Aurora Medical Center
		Dhimant R. Patel	Ph: 800-252-2990
	Waukesha
	Waukesha Memorial Hospital Regional Cancer Center
		Michael A Thompson	Ph: 262-928-7632
	Wauwatosa
	Oncology Alliance, SC - Milwaukee - West
		Rubina Qamar	Ph: 888-709-2080
	Weston
	Diagnostic and Treatment Center
		Matthias Weiss	Ph: 800-347-0673
	Marshfield Clinic - Weston Center
		Matthias Weiss	Ph: 800-347-0673
	Wisconsin Rapids
	Marshfield Clinic - Wisconsin Rapids Center
		Matthias Weiss	Ph: 800-347-0673

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01169337
Information obtained from ClinicalTrials.gov on May 28, 2013