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

Basic Trial Information

Trial Description

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy also work in different ways to kill more cancer cells or stop them from growing. It is not yet known whether rituximab is more effective with combination chemotherapy or bendamustine hydrochloride in treating patients with mantle cell lymphoma undergoing peripheral blood stem cell transplantation.

PURPOSE: This randomized phase II trial studies how well giving rituximab together with combination chemotherapy or bendamustine hydrochloride followed by consolidation chemotherapy and peripheral blood stem cell transplantation works in treating older patients with previously untreated mantle cell lymphoma.

Further Study Information

OBJECTIVES:

• To estimate the 2-year progression-free survival (PFS) of patients with newly diagnosed mantle cell lymphoma (MCL) treated with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, dexamethasone (RHCVAD), methotrexate and cytarabine (MTX/Ara-C), and autologous stem cell transplant (ASCT) or rituximab and bendamustine (R-bendamustine) and autologous stem cell transplant and to select a regimen for further development.

• To assess the response rate and overall survival of patients with newly diagnosed MCL treated with R-HCVAD/MTX/Ara-C and ASCT or R-bendamustine and ASCT.

• To assess the toxicity and tolerability of R-HCVAD/MTX/Ara-C and ASCT or R-bendamustine and ASCT in patients with newly diagnosed MCL.

• To determine the prognostic value of quantitative minimal-residual disease (MRD) monitoring in the peripheral blood of MCL patients after induction therapy and serially after high-dose chemotherapy and ASCT on treatment outcome.

• To bank diagnostic tissue sections for future translational research studies.

OUTLINE: This is a multicenter study. Patients are stratified according to risk classification by Mantle Cell Lymphoma International prognostic Index (MIPI) score (low risk vs intermediate/high risk). Patients are randomized to 1 of 2 treatment arms.

• Arm I (induction therapy):

• Courses 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2.

• Course 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of course 2.

• Each course is 21 days long and continues in the absence of disease progression or unacceptable toxicity.

• Arm II (induction therapy):

• Course 1-6: Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-4 weeks later, patients with responsive disease receive 2 additional courses of treatment.

• Stem cell mobilization: Beginning within 8 weeks, patients receive rituximab IV and cyclophosphamide IV over 1 hour on day 1. Patients then undergo stem cell collection about 26 days later.

Consolidation therapy: Patients receive one of the following preparative regimens.

• BCV* chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2.

• BEAM* chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.

• TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2.

• NOTE: * Patients 61 years of age or older receive either BCV or BEAM.

• NOTE: * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 8 years from registration.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• All patients must have previously untreated stage III, IV, or bulky stage II mantle cell lymphoma (MCL)

• A diagnosis of MCL must be confirmed by histopathological diagnosis including immunohistochemistry and flow cytometry documenting both of the following phenotypes:

• CD19+ or CD20+

• Cyclin D1+ or evidence of the t(11;14) translocation by cytogenetics or FISH

• Adequate sections from the original diagnostic specimen must be available for submission for central review

• An adequate biopsy requires sufficient tissue to establish the architecture and a WHO histologic subtype with certainty

• Core biopsies, especially multiple core biopsies, MAY be adequate, but needle aspirations or cytologies are not adequate

• Bone marrow core biopsy or clot sections (not aspirates) may be used as diagnostic material if it is significantly involved and are the only diagnostic material available

• All patients must have bidimensional measurable disease documented on the Lymphoma Baseline Tumor Assessment Form (Form #48031)

• Patients who also have non-measurable disease in addition to measurable disease must have all nonmeasurable disease assessed within 28 days prior to registration

• Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma

• Any laboratory or radiographic tests performed prior to registration to assess CNS involvement must be negative

• Patients must have a unilateral/bilateral bone marrow aspirate and biopsy for staging performed within 42 days prior to registration

• If the biopsy cannot be performed but the aspirate is unequivocally consistent with mantle cell lymphoma, this will be considered adequate for staging purposes

• Patients must be eligible for stem cell transplantation by institutional guidelines with the plan that transplant will be conducted at a cooperative group-approved transplant center

• Patients must be planning to undergo stem cell transplantation within 84 days after day 1 of the last induction course

• Patients must have had at least 1.5 X 10^6 CD34^+ cells/kg collected and stored prior to second registration for stem cell transplantation

PATIENT CHARACTERISTICS:

• Zubrod performance status of 0-2

• Bilirubin ≤ 3 times upper limit of normal (ULN)

• Serum creatinine ≤ 2.0 times ULN

• ALT and AST ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• Platelet count ≥ 100,000/mcL, unless due to bone marrow infiltration by lymphoma

• All patients ≥ 45 years of age must have an echocardiogram (ECHO) or MUGA scan within 42 days prior to registration (whichever method is used at baseline must be used at restaging)

• Patients < 45 years of age should have ECHO/MUGA only if clinically indicated

• Patients with an ejection fraction < institutional lower limit of normal (ILLN) are not eligible

• Serum LDH and a CBC with differential must be measured within 28 days prior to registration

• Patients known to be HIV positive, or who have a history of solid organ transplantation, are ineligible

• No active hepatitis

• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated Stage I or II cancer from which the patient is currently in complete remission; or any other cancer from which the patient has been disease-free for 5 years

• Pregnant or nursing women may not participate

• Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

Steven H. Bernstein

Principal Investigator

U.S.A.
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Robert W Chen	Ph: 800-826-4673
			Email: becomingapatient@coh.org
	Sacramento
	University of California Davis Cancer Center
		Mehrdad Abedi	Ph: 916-734-3089
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
	Kaiser Permanente of Colorado
		Alexander Menter	Ph: 303-614-1300
	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
	Greeley
	North Colorado Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Lafayette
	Kaiser Permanente - Lafayette
		Alexander Menter	Ph: 303-614-1300
	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
	Wheat Ridge
	Exempla Lutheran Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Frank Beardell	Ph: 302-733-6227
	Newark
	Helen F. Graham Cancer Center at Christiana Hospital
		Frank Beardell	Ph: 302-733-6227
Florida
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Lee M. Zehngebot	Ph: 407-303-5623
Idaho
	Lewiston
	St. Joseph Regional Medical Center
		Yoshio Inoue	Ph: 253-403-2394
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
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Jane N. Winter	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		James L. Wade	Ph: 217-876-4740
			Email: kcheek@dmhhs.org
	Eureka
	Eureka Community Hospital
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	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
	Highland Park
	Hematology Oncology Associates of Illinois-Highland Park
		Jane N. Winter	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Kankakee
	Provena St. Mary's Regional Cancer Center - Kankakee
		Jane N. Winter	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Kewanee
	Illinois CancerCare - Kewanee Clinic
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Libertyville
	North Shore Oncology and Hematology Associates, Limited - Libertyville
		Jane N. Winter	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Macomb
	Illinois CancerCare - Macomb
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	McDonough District Hospital
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Scott E. Smith	Ph: 708-226-4357
	Monmouth
	Illinois CancerCare - Monmouth
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Niles
	Cancer Care and Hematology Specialists of Chicagoland - Niles
		Jane N. Winter	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Normal
	BroMenn Regional Medical Center
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Community Cancer Center
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Illinois CancerCare - Community Cancer Center
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Ottawa
	Community Hospital of Ottawa
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Illinois CancerCare - Ottawa
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Pekin
	Cancer Treatment Center at Pekin Hospital
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	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
	Methodist Medical Center of Illinois
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Proctor Hospital
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Peru
	Illinois CancerCare - Princeton
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Illinois Valley Community Hospital
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Princeton
	Illinois CancerCare - Princeton
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Skokie
	Hematology Oncology Associates - Skokie
		Jane N. Winter	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Spring Valley
	Illinois CancerCare - Spring Valley
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	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
	Indianapolis
	St. Francis Hospital Cancer Care Services
		Howard M. Gross	Ph: 317-783-8918
	Richmond
	Reid Hospital & Health Care Services
		Howard M. Gross	Ph: 317-783-8918
Iowa
	Ames
	McFarland Clinic, PC
		Joseph James Merchant	Ph: 515-239-2621
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Bruce Wender	Ph: 712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Bruce Wender	Ph: 712-252-0088
	St. Luke's Regional Medical Center
		Donald Bruce Wender	Ph: 712-252-0088
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker R. Dakhil	Ph: 316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker R. Dakhil	Ph: 316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker R. Dakhil	Ph: 316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker R. Dakhil	Ph: 316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker R. Dakhil	Ph: 316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker R. Dakhil	Ph: 316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker R. Dakhil	Ph: 316-262-4467
	Liberal
	Cancer Center of Kansas, PA - Liberal
		Shaker R. Dakhil	Ph: 316-262-4467
	McPherson
	Cancer Center of Kansas, PA - McPherson
		Shaker R. Dakhil	Ph: 316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker R. Dakhil	Ph: 316-262-4467
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker R. Dakhil	Ph: 316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker R. Dakhil	Ph: 316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker R. Dakhil	Ph: 316-262-4467
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker R. Dakhil	Ph: 316-262-4467
	Wichita
	Associates in Women's Health, PA - North Hillside
		Shaker R. Dakhil	Ph: 316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker R. Dakhil	Ph: 316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker R. Dakhil	Ph: 316-262-4467
	CCOP - Wichita
		Shaker R. Dakhil	Ph: 316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker R. Dakhil	Ph: 316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker R. Dakhil	Ph: 316-262-4467
Kentucky
	Lexington
	University of Kentucky Chandler Medical Center
		John W Hayslip	Ph: 859-257-3379
Maryland
	Elkton MD
	Union Hospital of Cecil County
		Frank Beardell	Ph: 302-733-6227
Michigan
	Adrian
	Hickman Cancer Center at Bixby Medical Center
		Rex B Mowat	Ph: 517-265-0116
		Rex B Mowat	Ph: 517-265-0116
	Detroit
	Wayne State University
		Radhakrishnan Ramchandren	Ph: 313-576-9363
	Monroe
	Community Cancer Center of Monroe
		Rex B Mowat	Ph: 517-265-0116
	Mercy Memorial Hospital - Monroe
		Rex B Mowat	Ph: 517-265-0116
Minnesota
	Burnsville
	Fairview Ridges Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Edina
	Fairview Southdale Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Hutchinson
	Hutchinson Area Health Care
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minnesota Oncology - Maplewood
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	New Ulm
	New Ulm Medical Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Robbinsdale
	Humphrey Cancer Center at North Memorial Outpatient Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Park Nicollet Cancer Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Saint Paul
	Regions Hospital Cancer Care Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	United Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Stillwater
	Lakeview Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Waconia
	Ridgeview Medical Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Willmar
	Willmar Cancer Center at Rice Memorial Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Woodbury
	Minnesota Oncology - Woodbury
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
Missouri
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Nancy L. Bartlett	Ph: 800-600-3606
			Email: info@siteman.wustl.edu
New Jersey
	Camden
	Cancer Institute of New Jersey at Cooper University Hospital - Camden
		Frank Beardell	Ph: 302-733-6227
	Hamilton
	Cancer Institute of New Jersey at Hamilton
		Kevin A David	Ph: 732-235-8675
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Kevin A David	Ph: 732-235-8675
New York
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Jonathan W Friedberg	Ph: 585-275-5830
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Thomas C. Shea	Ph: 877-668-0683
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		David Duane Hurd	Ph: 336-713-6771
Ohio
	Bowling Green
	Wood County Oncology Center
		Rex B Mowat	Ph: 517-265-0116
	Cincinnati
	Jewish Hospital Cancer Center
		E. Randolph Broun	Ph: 513-686-5482
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Kristie A. Blum	Ph: 866-627-7616
			Email: osu@emergingmed.com
	Dayton
	CCOP - Dayton
		Howard M. Gross	Ph: 317-783-8918
	David L. Rike Cancer Center at Miami Valley Hospital
		Howard M. Gross	Ph: 317-783-8918
	Good Samaritan Hospital
		Howard M. Gross	Ph: 317-783-8918
	Grandview Hospital
		Howard M. Gross	Ph: 317-783-8918
	Samaritan North Cancer Care Center
		Howard M. Gross	Ph: 317-783-8918
	Elyria
	Hematology Oncology Center
		Rex B Mowat	Ph: 517-265-0116
	Findlay
	Blanchard Valley Regional Cancer Center
		Howard M. Gross	Ph: 317-783-8918
	Franklin
	Atrium Medical Center
		Howard M. Gross	Ph: 317-783-8918
	Greenville
	Wayne Hospital
		Howard M. Gross	Ph: 317-783-8918
	Kettering
	Charles F. Kettering Memorial Hospital
		Howard M. Gross	Ph: 317-783-8918
	Lima
	Lima Memorial Hospital
		Rex B Mowat	Ph: 517-265-0116
	Maumee
	Northwest Ohio Oncology Center
		Rex B Mowat	Ph: 517-265-0116
		Rex B Mowat	Ph: 517-265-0116
	Oregon
	St. Charles Mercy Hospital
		Rex B Mowat	Ph: 517-265-0116
	Toledo Clinic - Oregon
		Rex B Mowat	Ph: 517-265-0116
	Sylvania
	Flower Hospital Cancer Center
		Rex B Mowat	Ph: 517-265-0116
	Tiffin
	Mercy Hospital of Tiffin
		Rex B Mowat	Ph: 517-265-0116
	Toledo
	St. Anne Mercy Hospital
		Rex B Mowat	Ph: 517-265-0116
	St. Vincent Mercy Medical Center
		Rex B Mowat	Ph: 517-265-0116
	Toledo Clinic, Incorporated - Main Clinic
		Rex B Mowat	Ph: 517-265-0116
	Toledo Hospital
		Rex B Mowat	Ph: 517-265-0116
	University of Toledo Medical Center
		Rex B Mowat	Ph: 517-265-0116
	Troy
	UVMC Cancer Care Center at Upper Valley Medical Center
		Howard M. Gross	Ph: 317-783-8918
	Wauseon
	Fulton County Health Center
		Rex B Mowat	Ph: 517-265-0116
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard M. Gross	Ph: 317-783-8918
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		George B Selby	Ph: 405-271-4272
			Email: julie-traylor@ouhsc.edu
	Tulsa
	Natalie Warren Bryant Cancer Center at St. Francis Hospital
		Joseph P. Lynch	Ph: 918-494-2200
Oregon
	Clackamas
	Clackamas Radiation Oncology Center
		Stacy K Lewis	Ph: 503-215-6412
	Milwaukie
	Providence Milwaukie Hospital
		Stacy K Lewis	Ph: 503-215-6412
	Newberg
	Providence Newberg Medical Center
		Stacy K Lewis	Ph: 503-215-6412
	Oregon City
	Willamette Falls Hospital
		Stacy K Lewis	Ph: 503-215-6412
	Portland
	CCOP - Columbia River Oncology Program
		Stacy K Lewis	Ph: 503-215-6412
	Providence Cancer Center at Providence Portland Medical Center
		Stacy K Lewis	Ph: 503-215-6412
	Providence St. Vincent Medical Center
		Stacy K Lewis	Ph: 503-215-6412
Pennsylvania
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Edward J Gorak	Ph: 570-271-5251
	Hazleton
	Geisinger Hazleton Cancer Center
		Edward J Gorak	Ph: 570-271-5251
	State College
	Geisinger Medical Group - Scenery Park
		Edward J Gorak	Ph: 570-271-5251
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		Edward J Gorak	Ph: 570-271-5251
South Carolina
	Greenville
	Cancer Centers of the Carolinas - Faris Road
		Suzanne R Fanning	Ph: 864-241-6251
	Cancer Centers of the Carolinas - Grove Commons
		Suzanne R Fanning	Ph: 864-241-6251
	CCOP - Greenville
		Suzanne R Fanning	Ph: 864-241-6251
	Greenville Memorial Hospital
		Suzanne R Fanning	Ph: 864-241-6251
	Greer
	Cancer Centers of the Carolinas - Greer Medical Oncology
		Suzanne R Fanning	Ph: 864-241-6251
	Seneca
	Cancer Centers of the Carolinas - Seneca
		Suzanne R Fanning	Ph: 864-241-6251
	Spartanburg
	Cancer Centers of the Carolinas - Spartanburg
		Suzanne R Fanning	Ph: 864-241-6251
Texas
	Dallas
	Baylor University Medical Center - Dallas
		Alan M. Miller	Ph: 800-422-9567
Virginia
	Fredericksburg
	Fredericksburg Oncology Inc
		Rex B Mowat	Ph: 517-265-0116
Washington
	Anacortes
	Cancer Care Center at Island Hogs
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Auburn
	Auburn Regional Center for Cancer Care
		Yoshio Inoue	Ph: 253-403-2394
	Bellevue
	Overlake Cancer Center at Overlake Hospital Medical Center
		Yoshio Inoue	Ph: 253-403-2394
	Bellingham
	St. Joseph Cancer Center
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Bremerton
	Olympic Hematology and Oncology
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Burien
	Highline Medical Center Cancer Center
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Centralia
	Providence Centralia Hospital
		Yoshio Inoue	Ph: 253-403-2394
	Edmonds
	Swedish Cancer Institute at Stevens Hospital
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Everett
	Providence Regional Cancer Partnership
		Yoshio Inoue	Ph: 253-403-2394
	Federal Way
	St. Francis Hospital
		Yoshio Inoue	Ph: 253-403-2394
	Issaquah
	Swedish Medical Center - Issaquah Campus
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Kennewick
	Columbia Basin Hematology
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Mount Vernon
	Skagit Valley Hospital Cancer Care Center
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Olympia
	Providence St. Peter Hospital Regional Cancer Center
		Yoshio Inoue	Ph: 253-403-2394
	Poulsbo
	Harrison Poulsbo Hematology and Onocology
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Puyallup
	Good Samaritan Cancer Center
		Yoshio Inoue	Ph: 253-403-2394
	Seattle
	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Group Health Central Hospital
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Harborview Medical Center
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Minor and James Medical, PLLC
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	University Cancer Center at University of Washington Medical Center
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Sedro-Woolley
	North Puget Oncology at United General Hospital
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Spokane
	Cancer Care Northwest - Spokane South
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Evergreen Hematology and Oncology, PS
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Tacoma
	Allenmore Hospital
		Yoshio Inoue	Ph: 253-403-2394
	CCOP - Northwest
		Yoshio Inoue	Ph: 253-403-2394
	Franciscan Cancer Center at St. Joseph Medical Center
		Yoshio Inoue	Ph: 253-403-2394
	MultiCare Regional Cancer Center at Tacoma General Hospital
		Yoshio Inoue	Ph: 253-403-2394
	St. Clare Hospital
		Yoshio Inoue	Ph: 253-403-2394
	Vancouver
	Northwest Cancer Specialists at Vancouver Cancer Center
		Stacy K Lewis	Ph: 503-215-6412
	Southwest Washington Medical Center Cancer Center
		Stacy K Lewis	Ph: 503-215-6412
	Wenatchee
	Wenatchee Valley Medical Center
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
West Virginia
	Morgantown
	Mary Babb Randolph Cancer Center at West Virginia University Hospitals
		Sayed M Hamadani	Ph: 304-293-2745
			Email: sfilburn@hsc.wvu.edu
Wisconsin
	Eau Claire
	Center for Cancer Treatment & Prevention at Sacred Heart Hospital
		Ali W. Bseiso	Ph: 715-389-4457
	Marshfield Clinic Cancer Care at Regional Cancer Center
		Ali W. Bseiso	Ph: 715-389-4457
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Kurt Oettel	Ph: 608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Vaishalee P Kenkre	Ph: 877-405-6866
	Marshfield
	Marshfield Clinic - Marshfield Center
		Ali W. Bseiso	Ph: 715-389-4457
	Saint Joseph's Hospital
		Ali W. Bseiso	Ph: 715-389-4457
	Milwaukee
	Froedtert Hospital and Medical College of Wisconsin
		Timothy S Fenske	Ph: 414-805-4380
	Minocqua
	Marshfield Clinic - Lakeland Center
		Ali W. Bseiso	Ph: 715-389-4457
	New Richmond
	Cancer Center of Western Wisconsin
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Rhinelander
	Ministry Medical Group at Saint Mary's Hospital
		Ali W. Bseiso	Ph: 715-389-4457
		Ali W. Bseiso	Ph: 715-389-4457
	Rice Lake
	Marshfield Clinic - Indianhead Center
		Ali W. Bseiso	Ph: 715-389-4457
	Stevens Point
	Marshfield Clinic at Saint Michael's Hospital
		Ali W. Bseiso	Ph: 715-389-4457
	Saint Michael's Hospital Cancer Center
		Ali W. Bseiso	Ph: 715-389-4457
	Weston
	Marshfield Clinic - Weston Center
		Ali W. Bseiso	Ph: 715-389-4457
	Ministry Saint Clare's Hospital
		Ali W. Bseiso	Ph: 715-389-4457
	Wisconsin Rapids
	Marshfield Clinic - Wisconsin Rapids Center
		Ali W. Bseiso	Ph: 715-389-4457

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01412879
Information obtained from ClinicalTrials.gov on November 20, 2012

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