Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

Condition(s) targeted: Leukemia

Intervention: arsenic trioxide (Drug); cytarabine (Drug); idarubicin (Drug); mercaptopurine (Drug); methotrexate (Drug); mitoxantrone hydrochloride (Drug); tretinoin (Drug); cytogenetic analysis (Genetic); polymerase chain reaction (Genetic); laboratory biomarker analysis (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
John J. Gregory, MD, Study Chair, Affiliation: Goryeb Children's Hospital at Morristown Memorial Hospital

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia.

Official title: Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® IND #103331) During Consolidation

Study design: Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Event-free survival

Secondary outcome:

Hematologic, molecular, and cytogenetic remission rates after each phase of therapy

Overall survival

Percentage of patients experiencing grade 3 or 4 toxicity, or cardiac toxicity of any grade

Time to blood count recovery

Duration of hospitalization

Detailed description: OBJECTIVES:

Primary

- To decrease the total anthracycline dose from the best current published results in

patients with standard-risk childhood acute promyelocytic leukemia (APL) while still maintaining a comparable event-free survival (EFS).

Secondary

- To assign treatment based on risk stratification by WBC at diagnosis.

- To estimate the induction failure rate, toxic death rate, disease-free survival rate,

and overall survival rate in both standard- and high-risk APL patients.

- To monitor for cardiotonicity in an idarubicin/mitoxantrone hydrochloride-based

regimen.

- To document the toxicity of a traditional chemotherapy/tretinoin-based regimen combined

with arsenic trioxide therapy.

- To compare the EFS of children enrolled on this study with the EFS of children enrolled

on CALGB-C9710 who were between the ages of 2 and 21 and did not receive arsenic trioxide.

- To estimate the proportion of patients who carry a cryptic t(15;17), i. e., those who

are positive for a PML-RARA fusion transcript by PCR analysis but have normal chromosomes.

- To estimate the proportion of patients with variant RARA partners.

- To compare the outcome of patients with only a t(15;17) with that of patients who carry

a t(15;17) and other chromosomal abnormalities.

OUTLINE: This is a multicenter study. Patients are treated based on risk factor (standard-risk [WBC < 10,000/mm^3] or high-risk [WBC ≥ 10,000/mm^3]).

- Induction therapy:

- Standard-risk: Patients receive oral tretinoin twice daily on days 1-30 and

idarubicin IV over 15 minutes once on days 3, 5, and 7.

- High-risk: Patients receive oral tretinoin twice daily on days 1-30 and idarubicin

IV over 15 minutes once on days 1, 3, and 5.

Patients proceed to consolidation therapy one week later or when blood counts recover.

- Consolidation therapy:

- Consolidation 1: Patients receive arsenic trioxide IV over 2 hours on days 1-5,

8-12, 15-19, 22-26, and 29-33 and oral tretinoin twice daily on days 1-14. Treatment repeats every 5 weeks for 2 courses, followed by a 2-week break, and then treatment repeats for 2 more courses. Beginning 1 week later or when blood counts recover, patients proceed to consolidation 2.

- Consolidation 2: Patients receive cytarabine intrathecally (IT) on day 1, oral

tretinoin twice daily on days 1-14, high-dose cytarabine IV over 3 hours every 12 hours on days 1-3, and mitoxantrone hydrochloride IV over 15-30 minutes once on days 3 and 4. Patients proceed to consolidation 3 1 week later or when blood counts recover.

- Consolidation 3: Patients receive cytarabine IT on day 1, oral tretinoin twice

daily on days 1-14, and idarubicin IV over 15 minutes once daily on days 1, 3, and 5. High-risk patients and those standard-risk patients who are positive for minimal residual disease by real-time quantitative (RQ)-PCR receive consolidation 4 one week later or when blood counts recover. All other standard-risk patients proceed to maintenance therapy.

- Consolidation 4 (patients with high-risk cytology): Patients receive cytarabine IT

on day 1, oral tretinoin twice daily on days 1-14, high-dose cytarabine IV over 3 hours every 12 hours on days 1-3, and idarubicin IV over 15 minutes once on day 4. Patients who demonstrate molecular complete remission (CR) and remain in hematological CR proceed to maintenance therapy 1 week later or when blood counts recover.

- Maintenance therapy: Patients receive cytarabine IT on day 1 (course 1 only), oral

tretinoin twice daily on days 1-14, oral mercaptopurine once daily on days 1-84, oral methotrexate once on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for 9 courses.

Bone marrow or blood is collected at baseline and then periodically during the study for RQ-PCR analysis. Tumor tissue is collected at baseline for cytogenetic analysis.

After completion of study treatment, patients are followed every month for 1 year, every 3 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

Minimum age: 2 Years. Maximum age: 21 Years. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- New clinically and morphologically confirmed diagnosis of acute promyelocytic

leukemia (APL)

- If the real-time quantitative (RQ)-PCR results are known, the patient must

demonstrate PML-RARA and/or RARA-PML transcripts by RQ-PCR

- Patients without evidence of APL by bone marrow morphology but with isolated myeloid

sarcoma (myeloblastoma; chloroma, including leukemia cutis) are eligible provided that the t(15;17) translocation is documented on either marrow or tumor tissue by cytogenetics, FISH, or PCR prior to study enrollment (in this situation, touch preps from the tumor site can be evaluated by FISH with PML-RARA probes)

PATIENT CHARACTERISTICS:

- No minimal performance status criteria

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No pre-existing prolonged QT syndrome

PRIOR CONCURRENT THERAPY:

- Prior intrathecal cytarabine prior to the diagnosis of acute promyelocytic leukemia

(APL) allowed

- Prior corticosteroids, hydroxyurea, and leukapheresis allowed

- No prior systemic definitive treatment for APL, including cytotoxic chemotherapy,

retinoids, or arsenic

Centre Hospitalier Universitaire de Quebec, Quebec G1V 4G2, Canada; Recruiting
Bruno Michon, Phone: 418-656-4141X47191

San Jorge Children's Hospital, Santurce 00912, Puerto Rico; Recruiting
Luis A. Clavell, Phone: 787-728-1575

UAB Comprehensive Cancer Center, Birmingham, Alabama 35294, United States; Recruiting
Clinical Trials Office - UAB Comprehensive Cancer Center, Phone: 205-934-0309

Phoenix Children's Hospital, Phoenix, Arizona 85016-7710, United States; Recruiting
Jessica L. Boklan, Phone: 602-546-0920

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States; Recruiting
Clinical Trial Office - Arkansas Cancer Research Center at Uni, Phone: 501-686-8274

Children's and Women's Hospital of British Columbia, Vancouver, British Columbia V6H 3V4, Canada; Recruiting
Caron Strahlendorf, Phone: 604-875-3576

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California 92354, United States; Recruiting
Clinical Trials Office - Loma Linda University Cancer Institut, Phone: 909-558-3375

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California 90801, United States; Recruiting
Jerry Z. Finklestein, Phone: 562-728-5000

Southern California Permanente Medical Group, Los Angeles, California 90027, United States; Recruiting
Robert M. Cooper, Phone: 323-783-5307

Childrens Hospital Los Angeles, Los Angeles, California 90027, United States; Recruiting
Leo Mascarenhas, Phone: 323-361-2529

Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California 90095-1781, United States; Recruiting
Clinical Trials Office - Jonsson Comprehensive Cancer Center a, Phone: 888-798-0719

Children's Hospital Central California, Madera, California 93638-8762, United States; Recruiting
Vonda L. Crouse, Phone: 559-353-5480

Children's Hospital and Research Center Oakland, Oakland, California 94609, United States; Recruiting
Clinical Trial Office - Children's Hospital and Research Cente, Phone: 510-450-7600

Children's Hospital of Orange County, Orange, California 92868, United States; Recruiting
Violet Shen, Phone: 714-532-8636

Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California 95798, United States; Recruiting
Neyssa M. Marina, Phone: 650-723-5535

Sutter Cancer Center, Sacramento, California 95816, United States; Recruiting
Clinical Trial Office - Sutter Cancer Center, Phone: 916-454-6595

Rady Children's Hospital - San Diego, San Diego, California 92123-4282, United States; Recruiting
Clinical Trials Office - Rady Children's Hospital - San Diego, Phone: 858-966-5934

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States; Recruiting
Clinical Trials Office - UCSF Helen Diller Family Comprehensi, Phone: 877-827-3222

Children's Hospital Colorado Center for Cancer and Blood Disorders, Aurora, Colorado 80045, United States; Recruiting
Kelly W. Maloney, Phone: 720-777-6673

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States; Recruiting
Clinical Trials Office - Connecticut Children's Medical Center, Phone: 860-545-9967

Alfred I. duPont Hospital for Children, Wilmington, Delaware 19803, United States; Recruiting
Clinical Trials Office - Alfred I. duPont Hospital for Childre, Phone: 302-651-5755

Children's National Medical Center, Washington, District of Columbia 20010-2970, United States; Recruiting
Clinical Trials Office - Children's National Medical Center, Phone: 202-884-2549

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia 20007, United States; Recruiting
Clinical Trials Office - Lombardi Comprehensive Cancer Center, Phone: 202-444-0381

Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida 33901, United States; Recruiting
Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt, Phone: 877-680-0008

Nemours Children's Clinic, Jacksonville, Florida 32207, United States; Recruiting
Eric S. Sandler, Phone: 904-697-3793

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida 33136, United States; Recruiting
University of Miami Sylvester Comprehensive Cancer Center Clin, Phone: 866-574-5124, Email: Sylvester@emergingmed.com

Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida 32803-1273, United States; Recruiting
Clinical Trials Office - Florida Hospital Cancer Institute, Phone: 407-303-5623

M.D. Anderson Cancer Center at Orlando, Orlando, Florida 32806, United States; Recruiting
Vincent F. Giusti, Phone: 321-841-8588

Nemours Children's Clinic - Orlando, Orlando, Florida 32806, United States; Recruiting
Ramamoorthy Nagasubramanian, Phone: 407-650-7230

Nemours Children's Clinic - Pensacola, Pensacola, Florida 32504, United States; Recruiting
Jeffrey H. Schwartz, Phone: 850-505-4790

All Children's Hospital, Saint Petersburg, Florida 33701, United States; Recruiting
Gregory A. Hale, Phone: 727-767-4176

St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida 33607, United States; Recruiting
Clinical Trials Office - St. Joseph's Cancer Institute, Phone: 800-882-4123

Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida 33407, United States; Recruiting
Narayana Gowda, Phone: 561-844-6363

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia 30322, United States; Recruiting
Todd M. Cooper, Phone: 404-785-1838

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia 31403-3089, United States; Recruiting
Clinical Trials Office - Curtis and Elizabeth Anderson Cancer, Phone: 912-350-8568

Cancer Research Center of Hawaii, Honolulu, Hawaii 96813, United States; Recruiting
Clinical Trials Office - Cancer Research Center of Hawaii, Phone: 808-586-2979

Children's Memorial Hospital - Chicago, Chicago, Illinois 60614, United States; Recruiting
Stewart Goldman, Phone: 773-880-3270

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois 60153, United States; Recruiting
Clinical Trials Office - Cardinal Bernardin Cancer Center, Phone: 708-226-4357

Keyser Family Cancer Center at Advocate Hope Children's Hospital, Oak Lawn, Illinois 60453, United States; Recruiting
Sharad N. Salvi, Phone: 708-684-4094

Saint Jude Midwest Affiliate, Peoria, Illinois 61637, United States; Recruiting
Pedro A. De Alarcon, Phone: 309-655-4242

Riley's Children Cancer Center at Riley Hospital for Children, Indianapolis, Indiana 46202-5225, United States; Recruiting
James M. Croop, Phone: 317-274-8784

St. Vincent Indianapolis Hospital, Indianapolis, Indiana 46260, United States; Recruiting
Clinical Trials Office - St. Vincent Indianapolis Hospital, Phone: 317-338-2194

Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky 40536-0093, United States; Recruiting
Clinical Trials Office - Markey Cancer Center at University of, Phone: 859-257-3379

Kosair Children's Hospital, Louisville, Kentucky 40232, United States; Recruiting
Clinical Trials Office - Kosair Children's Hospital, Phone: 502-629-5500, Email: CancerResource@nortonhealthcare.org

Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana 71315-3198, United States; Recruiting
Clinical Trials Office - Tulane Cancer Center, Phone: 504-988-6121

CancerCare of Maine at Eastern Maine Medical Center, Bangor, Maine 04401, United States; Recruiting
Clinical Trials Office - CancerCare of Maine, Phone: 207-973-4274

CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada; Recruiting
Rochelle A. Yanofsky, Phone: 204-787-4163

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland 21215, United States; Recruiting
Joseph M. Wiley, Phone: 410-601-6266

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States; Recruiting
Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce, Phone: 410-955-8804, Email: jhcccro@jhmi.edu

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute, Boston, Massachusetts 2115, United States; Recruiting
Carlos Rodriguez-Galindo, Phone: 617-632-4580

Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts 01199-0001, United States; Recruiting
Contact Person, Phone: 413-794-9338

UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts 01655, United States; Recruiting
Christopher P. Keuker, Phone: 508-856-4225

C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan 48109-0286, United States; Recruiting
Clinical Trials Office - C.S. Mott Children's Hospital, Phone: 800-865-1125

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States; Recruiting
Clinical Trials Office - Barbara Ann Karmanos Cancer Institute, Phone: 313-576-9363

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan 49503, United States; Recruiting
Clinical Trials Office - Helen DeVos Children's Hospital, Phone: 616-391-3050

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States; Recruiting
Clincial Trials Office - Van Elslander Cancer Center at St. Jo, Phone: 313-343-3166

Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan 48910, United States; Recruiting
Clinical Trials Office - Breslin Cancer Center at Ingham Regio, Phone: 517-334-2765

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota 55404, United States; Recruiting
Clinical Trials Office - Children's Hospitals and Clinics of M, Phone: 612-813-5193

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States; Recruiting
Clinical Trials Office - All Mayo Clinic Locations, Phone: 507-538-7623

University of Mississippi Cancer Clinic, Jackson, Mississippi 39216-4505, United States; Recruiting
Gail C. Megason, Phone: 601-984-5220

Children's Mercy Hospital, Kansas City, Missouri 64108, United States; Recruiting
Maxine L. Hetherington, Phone: 816-234-3265

Cardinal Glennon Children's Hospital, St. Louis, Missouri 63104, United States; Recruiting
William S. Ferguson, Phone: 314-577-5638

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St. Louis, Missouri 63110, United States; Recruiting
Robert J. Hayashi, Phone: 314-454-2041

CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada 89109-2306, United States; Recruiting
Jonathan Bernstein, Phone: 702-732-1493

Hackensack University Medical Center Cancer Center, Hackensack, New Jersey 07601, United States; Recruiting
Clinical Trials Office - Hackensack University Medical Center, Phone: 201-996-2879

Overlook Hospital, Morristown, New Jersey 07962, United States; Recruiting
Steven L. Halpern, Phone: 973-971-6720

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States; Recruiting
Clinical Trials Office - Cancer Institute of New Jersey, Phone: 732-235-8675

St. Joseph's Hospital and Medical Center, Paterson, New Jersey 07503, United States; Recruiting
Mary A. Bonilla, Phone: 973-754-3349

University of New Mexico Cancer Center, Albuquerque, New Mexico 87131-5636, United States; Recruiting
Clinical Trials Office - University of New Mexico Cancer Cente, Phone: 505-272-6972

Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York 10461, United States; Recruiting
Clinical Trials Office - Albert Einstein Cancer Center at Albe, Phone: 718-904-2730, Email: aecc@aecom.yu.edu

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States; Recruiting
Clinical Trials Office - Roswell Park Cancer Institute, Phone: 877-275-7724

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Clinical Trials Office - Herbert Irving Comprehensive Cancer C, Phone: 212-305-8615

SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States; Recruiting
Clinical Trials Office - SUNY Upstate Medical University Hospi, Phone: 315-464-5476

Mission Hospitals - Memorial Campus, Asheville, North Carolina 28801, United States; Recruiting
Clinical Trials Office - Mission Hospitals - Memorial Campus, Phone: 828-213-4150

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States; Recruiting
Clinical Trials Office - Lineberger Comprehensive Cancer Cente, Phone: 877-668-0683; 919-966-4432

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States; Recruiting
Clinical Trials Office - Blumenthal Cancer Center at Carolinas, Phone: 704-355-2884

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina 28233-3549, United States; Recruiting
Clinical Trials Office - Presbyterian Cancer Center at Presbyt, Phone: 704-384-5369

Duke Cancer Institute, Durham, North Carolina 27710, United States; Recruiting
Clinical Trials Office - Duke Cancer Institute, Phone: 888-275-3853

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States; Recruiting
Clinical Trials Office - Wake Forest University Comprehensive, Phone: 336-713-6771

CCOP - MeritCare Hospital, Fargo, North Dakota 58122, United States; Recruiting
Nathan L. Kobrinsky, Phone: 701-234-7544

IWK Health Centre, Halifax, Nova Scotia B3J 3G9, Canada; Recruiting
Margaret C. Yhap, Phone: 902-470-8778

Akron Children's Hospital, Akron, Ohio 44308-1062, United States; Recruiting
Clinical Trials Office - Akron Children's Hospital, Phone: 330-543-3193

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, United States; Recruiting
Clinical Trials Office - Cincinnati Children's Hospital Medica, Phone: 513-636-2799

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States; Recruiting
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente, Phone: 866-223-8100

Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106-5000, United States; Recruiting
Yousif (Joe) H. Matloub, Phone: 216-844-3345

Nationwide Children's Hospital, Columbus, Ohio 43205-2696, United States; Recruiting
Laura T. Martin, Phone: 614-722-3582

Dayton Children's - Dayton, Dayton, Ohio 45404-1815, United States; Recruiting
Emmett H. Broxson, Phone: 937-641-3111

Toledo Hospital, Toledo, Ohio 43606, United States; Recruiting
Clinical Trials Office - Toledo Hospital, Phone: 419-824-1842

Oklahoma University Cancer Institute, Oklahoma City, Oklahoma 73104, United States; Recruiting
Rene Y. McNall-Knapp, Phone: 405-271-5311

Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H 8L1, Canada; Recruiting
Jacqueline M.L. Halton, Phone: 613-737-7600x2370

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Sylvain Baruchel, Phone: 416-813-7795

Knight Cancer Institute at Oregon Health and Science University, Portland, Oregon 97239-3098, United States; Recruiting
Clinical Trials Office - Knight Cancer Institute at Oregon Hea, Phone: 503-494-1080, Email: trials@ohsu.edu

Penn State Children's Hospital, Hershey, Pennsylvania 17033-0850, United States; Recruiting
John F. Kuttesch, Phone: 717-531-6012

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Elizabeth Fox, Phone: 267-425-3010

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Clinical Trials Office - Children's Hospital of Pittsburgh, Phone: 412-692-7056

Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada; Recruiting
Yvan Samson, Phone: 514-345-4969

Palmetto Health South Carolina Cancer Center, Columbia, South Carolina 29203, United States; Recruiting
Clinical Trials Office - Palmetto Health South Carolina Cancer, Phone: 803-434-3680

Greenville Hospital Cancer Center, Greenville, South Carolina 29605, United States; Recruiting
Clinical Trials Office - Greenville Hospital Cancer Center, Phone: 864-241-6251

St. Jude Children's Research Hospital, Memphis, Tennessee 38105, United States; Recruiting
Clinical Trials Office - St. Jude Children's Research Hospital, Phone: 901-595-4644

Driscoll Children's Hospital, Corpus Christi, Texas 78411, United States; Recruiting
Clinical Trials Office - Driscoll Children's Hospital, Phone: 361-694-5311

Cook Children's Medical Center - Fort Worth, Fort Worth, Texas 76104, United States; Recruiting
Clinical Trials Office - Cook's Children's Medical Center, Phone: 682-885-2103

Methodist Children's Hospital of South Texas, San Antonio, Texas 78229-3993, United States; Recruiting
Jaime Estrada, Phone: 210-575-7268

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78207, United States; Recruiting
Paul J. Thomas, Phone: 210-567-7477

Primary Children's Medical Center, Salt Lake City, Utah 84113-1100, United States; Recruiting
Phillip E. Barnette, Phone: 801-662-4700

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States; Recruiting
Julie R. Park, Phone: 206-987-2106

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54307-3508, United States; Recruiting
Clinical Trials Office - St. Vincent Hospital Regional Cancer, Phone: 920-433-8889

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States; Recruiting
Clinical Trials Office - Marshfield Clinic - Marshfield Center, Phone: 800-782-1581 ext. 94457

Midwest Children's Cancer Center at Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting
Michael E. Kelly, Phone: 414-456-4170

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2009
Last updated: December 7, 2011