Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Active	18 months to 29 years at relapse	NCI	COG-AALL02P2 AALL02P2, NCT00096135

Objectives

Primary

1. Determine the efficacy of intensified systemic chemotherapy with reduced-dose CNS radiotherapy in patients with acute lymphoblastic leukemia and late isolated CNS relapse.
2. Determine the efficacy of intensive systemic chemotherapy without testicular radiotherapy in patients with acute lymphoblastic leukemia and late isolated testicular relapse.
3. Determine the toxicity of these regimens in these patients.

Secondary

1. Determine whether bone marrow involvement is present at the time of extramedullary relapse in patients treated with these regimens.
2. Correlate pretreatment minimal residual disease with outcomes in patients treated with these regimens.
3. Correlate the role of host gene polymorphisms with toxicity of these regimens and incidence and outcome in these patients.
4. Determine the neuropsychological sequalae associated with isolated CNS relapse and these treatment regimens in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of acute lymphoblastic leukemia
  • T- or B-precursor lineage
  • In first bone marrow remission (M1 by morphology) AND duration of first complete remission ≥ 18 months from time of initial diagnosis
• First isolated CNS and/or testicular relapse
  • Isolated CNS relapse, as defined by 1 of the following:
    • WBC ≥ 5/mm³ in cerebrospinal fluid (CSF) with blasts present on cytospin
    • Any number of WBC in CSF with immunophenotypic proof of leukemic relapse, defined by the following:
      • Identifiable blasts AND 1 of the following:
        • B-lineage (TdT OR CD-10-positive on 2 consecutive CSF samples obtained 4 weeks apart)
        • T-lineage (TdT AND CD-7 OR TdT positivity alone on 2 consecutive CSF samples obtained 4 weeks apart)
  • Isolated testicular relapse, defined as biopsy proven testicular involvement
• No Down syndrome
• No known optic nerve and/or retinal involvement

Prior/Concurrent Therapy:

Biologic therapy

• No prior bone marrow transplantation

Chemotherapy

• Prior total anthracycline dosage ≤ 360 mg/m²

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior systemic therapy for concurrent extramedullary relapse

Patient Characteristics:

Age

• 18 months to 29 years at relapse

Performance status

• Karnofsky 30-100% (for patients > 16 years of age)

  OR

• Lansky 30-100% (for patients ≤ 16 years of age)

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Creatinine adjusted according to age as follows:
  • No greater than 0.4 mg/dL (≤ 5 months)
  • No greater than 0.5 mg/dL (6 months -11 months)
  • No greater than 0.6 mg/dL (1 year-23 months)
  • No greater than 0.8 mg/dL (2 years-5 years)
  • No greater than 1.0 mg/dL (6 years-9 years)
  • No greater than 1.2 mg/dL (10 years-12 years)
  • No greater than 1.4 mg/dL (13 years and over [female])
  • No greater than 1.5 mg/dL (13 years to 15 years [male])
  • No greater than 1.7 mg/dL (16 years and over [male])

  OR

• Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Cardiovascular

• Shortening fraction ≥ 27% by echocardiogram

  OR

• Ejection fraction ≥ 50% by MUGA

Other

• Not pregnant or nursing

Expected Enrollment

A total of 257 patients (143 with isolated CNS relapse and 114 with isolated testicular relapse) will be accrued for this study within 5.7 years.

Outline

This is a pilot, multicenter study. All patients receive common induction, consolidation, re-induction, and intensification chemotherapy. Patients are stratified to maintenance therapy according to site of extramedullary relapse (CNS vs testicular).

• Induction therapy (weeks 1-4): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-28; daunorubicin* IV over 15 minutes on days 1, 8, and 15; and intrathecal triple therapy** (ITT) comprising methotrexate, hydrocortisone, and cytarabine on days 1, 8, 15, and 22.

   [Note: *The total dose of anthracyclines on this study is capped at 450 mg/m². Once this dose is reached, all subsequent doses of daunorubicin are omitted.]

   [Note: **Patients with isolated testicular relapse receive ITT on day 1 only.]

  In addition to the above, patients with isolated testicular relapse also receive high-dose methotrexate IV continuously over 24 hours on day -14. Patients with clinical signs of disease at the end of induction undergo testicular biopsy.

  Patients with CNS disease who do not achieve CNS remission after induction therapy receive additional ITT as above on days 29 and 36.

• Consolidation therapy (weeks 5-10): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2 and 22-23 and pegaspargase intramuscularly (IM) on days 2 and 23. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on days 3 and 24 and continuing until blood counts recover.

  Patients with isolated testicular relapse with positive biopsy results at the end of induction undergo testicular radiotherapy once daily for a total of 12 fractions during consolidation therapy.

• Intensification I (weeks 11-22): Patients receive high-dose methotrexate with leucovorin calcium rescue IV over 24 hours on days 1, 22, 43, and 64 and oral mercaptopurine once daily on days 2-6, 23-27, 44-48, and 65-69. Patients also receive etoposide IV over 1 hour and cyclophosphomide IV over 15-30 minutes on days 8, 29, 50, and 71. Patients receive ITT* on days 15, 36, 57, and 78.

   [Note: *Patients with isolated testicular relapse receive ITT on days 36 and 78 only.]

• Reinduction therapy (weeks 23-26): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-28 (for patients < 13 years of age) OR twice daily on days 1-7 and 15-21 (for patients ≥ 13 years of age); and daunorubicin IV over 15 minutes on days 1, 8, and 15.
• Intensification II (weeks 27-50): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2, 43-44, 85-86, and 127-128; pegaspargase IM on days 2, 44, 86, and 128; ITT* on days 22, 64, 106, and 148; high-dose methotrexate IV continuously over 24 hours on days 29, 71, 113, and 155; oral mercaptopurine on days 30-34, 72-76, 114-118, and 156-160; and etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 36, 78, 120, and 162. Patients also receive G-CSF SC beginning on days 3, 45, 87, and 129 and continuing until blood counts recover.

   [Note: *Patients with isolated testicular relapse receive ITT on days 22 and 106 only.]

• Chemotherapy and radiotherapy (weeks 51-54): Patients receive dexamethasone orally or IV twice daily on days 1-21 (for patients < 13 years of age) OR on days 1-7 and 15-21 (for patients ≥ 13 years of age). Patients also receive vincristine IV on days 1, 8, and 15 and pegaspargase IM on days 1 and 15.

  Patients with isolated CNS relapse also undergo cranial radiotherapy once daily, 5 days a week, for a total of 8 fractions.

• Maintenance therapy for isolated CNS relapse: (weeks 55-104): Patients receive dexamethasone orally or IV twice daily on days 1-5; oral mercaptopurine once daily on days 1-42; methotrexate IM on days 1, 8, 15, 22, 29, and 36; and vincristine IV and cyclophosphomide IV over 1 hour on days 43, 50, 57, and 64. Treatment repeats every 10 weeks for 5 courses.
• Maintenance therapy for isolated testicular relapse:
  • (Weeks 55-74): Patients receive ITT on day 1 and dexamethasone, mercaptopurine, methotrexate, vincristine, and cyclophosphomide as in maintenance therapy for isolated CNS relapse. Treatment repeats every 10 weeks for 2 courses.
  • (Weeks 75-106): Patients receive vincristine IV on day 1; dexamethasone orally or IV on days 1-5; oral mercaptopurine on days 1-28; and methotrexate IM on days 1, 8, 15, and 22. Treatment repeats every 28 days for 8 courses. Patients also receive ITT on day 1 every 12 weeks for 3 doses.

Patients with combined testicular and CNS relapse receive high-dose methotrexate IV continuously over 24 hours on day -14 in addition to the same chemotherapy and radiotherapy administered during the induction, consolidation, intensification I, reinduction, intensification II, and maintenance phases of therapy as isolated CNS relapse patients.

All patients undergo neuropsychological assessment within 3 months after completion of induction therapy (before cranial radiotherapy) and at 2 years after completion of treatment.

Patients are followed for survival.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Julio Barredo, MD, Protocol chair		Ph: 843-792-2957 Email: barredjc@musc.edu
Caroline Hastings, MD, Protocol co-chair		Ph: 510-428-3631 Email: chastings@mail.cho.org

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Clinical Trials Office - UAB Comprehensive Cancer Center	Ph:  205-934-0309
Arizona
	Phoenix
	Phoenix Children's Hospital
		Jessica Boklan	Ph:  602-546-0920
	Tucson
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Clinical Trials Office - Arizona Cancer Center at University of Arizona Health Sciences Center	Ph:  520-626-9008
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Ph:  501-686-8274
California
	Downey
	Southern California Permanente Medical Group
		Robert Cooper	Ph:  323-783-5307
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	Loma Linda
	Loma Linda University Cancer Institute at Loma Linda University Medical Center
		Clinical Trials Office - Loma Linda University Cancer Institute	Ph:  909-558-3375
	Long Beach
	Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
		Jerry Finklestein	Ph:  562-492-1062
	Los Angeles
	Jonsson Comprehensive Cancer Center at UCLA
		Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA	Ph:  888-798-0719
	Madera
	Children's Hospital Central California
		Vonda Crouse	Ph:  559-353-5480
	Oakland
	Children's Hospital and Research Center Oakland
		Clinical Trial Office - Children's Hospital and Research Center Oakland	Ph:  510-450-7600
	Orange
	Children's Hospital of Orange County
		Violet Shen	Ph:  714-532-8636
	Sacramento
	Kaiser Permanente Medical Center - Oakland
		Vincent Kiley	Ph:  916-474-2326
	Sutter Cancer Center
		Clinical Trial Office - Sutter Cancer Center	Ph:  916-454-6595
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph:  650-498-7061
			Email: cctoffice@stanford.edu
Colorado
	Aurora
	Children's Hospital Center for Cancer and Blood Disorders
		Kelly Maloney	Ph:  720-777-6673
	Denver
	Presbyterian - St. Luke's Medical Center
		Clinical Trials Office - Presbyterian - St. Luke's Medical Center	Ph:  303-839-6000
Connecticut
	Farmington
	Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
		Clinical Trials Office - Carole and Ray Neag Comprehensive Cancer Center	Ph:  800-579-7822
Delaware
	Wilmington
	Alfred I. duPont Hospital for Children
		Clinical Trials Office - Alfred I. duPont Hospital for Children	Ph:  302-651-5755
District of Columbia
	Washington
	Children's National Medical Center
		Clinical Trials Office - Children's National Medical Center	Ph:  202-884-2549
Florida
	Fort Lauderdale
	Broward General Medical Center Cancer Center
		Clinical Trials Office - Broward General Medical Center Cancer Center	Ph:  954-355-5346
	Fort Myers
	Lee Cancer Care of Lee Memorial Health System
		Clinical Trials Office - Lee Cancer Care of Lee Memorial Health System	Ph:  877-680-0008
	Gainesville
	University of Florida Shands Cancer Center
		Clinical Trials Office - University of Florida Shands Cancer Center	Ph:  888-254-7581
	Hollywood
	Memorial Cancer Institute at Memorial Regional Hospital
		Clinical Trials Office - Memorial Cancer Institute	Ph:  954-985-3443
	Jacksonville
	Nemours Children's Clinic
		Eric Sandler	Ph:  904-697-3793
	Miami
	Baptist-South Miami Regional Cancer Program
		Doured Daghistani	Ph:  305-274-1662
	Miami Children's Hospital
		Enrique Escalon	Ph:  305-662-8360x4960
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service	Ph:  866-574-5124
			Email: Sylvester@emergingmed.com
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clinical Trials Office - Florida Hospital Cancer Institute	Ph:  407-303-5623
	Nemours Children's Clinic - Orlando
		Paul Gordon	Ph:  407-650-7330
	Pensacola
	Sacred Heart Cancer Center at Sacred Heart Hospital
		Clinical Trials Office - Sacred Heart Cancer Center	Ph:  850-416-4611
	St. Petersburg
	All Children's Hospital
		Gregory Hale	Ph:  727-767-4176
	Tampa
	St. Joseph's Cancer Institute at St. Joseph's Hospital
		Clinical Trials Office - St. Joseph's Cancer Institute	Ph:  800-882-4123
	West Palm Beach
	Kaplan Cancer Center at St. Mary's Medical Center
		Narayana Gowda	Ph:  561-844-6363
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Howard Katzenstein	Ph:  404-785-0853
Idaho
	Boise
	Mountain States Tumor Institute at St. Luke's Regional Medical Center
		Eugenia Chang	Ph:  208-381-2731
Illinois
	Chicago
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
	Oak Lawn
	Advocate Christ Medical Center
		Sharad Salvi	Ph:  708-684-4094
	Park Ridge
	Advocate Lutheran General Cancer Care Center
		Clinical Trials Office - Advocate Lutheran General Cancer Care Center	Ph:  847-384-3621
	Springfield
	Simmons Cooper Cancer Institute
		Clinical Trials Office - Simmons Cooper Cancer Institute	Ph:  217-545-7929
Indiana
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
	St. Vincent Indianapolis Hospital
		Clinical Trials Office - St. Vincent Indianapolis Hospital	Ph:  317-338-2194
Iowa
	Des Moines
	Blank Children's Hospital
		Clinical Trials Office - Blank Children's Hospital	Ph:  515-241-6729
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Kansas
	Kansas City
	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
		Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Ph:  913-588-4709
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center	Ph:  859-257-3379
	Louisville
	Kosair Children's Hospital
		Clinical Trials Office - Kosair Children's Hospital	Ph:  502-629-5500
			Email: CancerResource@nortonhealthcare.org
Maine
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Clinical Trials Office - CancerCare of Maine	Ph:  207-973-4274
Maryland
	Baltimore
	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
		Joseph Wiley	Ph:  410-601-5864
Massachusetts
	Boston
	Floating Hospital for Children at Tufts - New England Medical Center
		Cynthia Kretschmar	Ph:  617-636-5535
Michigan
	Ann Arbor
	C.S. Mott Children's Hospital at University of Michigan Medical Center
		Clinical Trials Office - C.S. Mott Children's Hospital	Ph:  1-800-865-1125
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	Flint
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		David Dickens	Ph:  616-391-2086
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center	Ph:  313-343-3166
	Kalamazoo
	CCOP - Kalamazoo
		Leonard Mattano, Jr.	Ph:  269-341-6350
Minnesota
	Minneapolis
	Children's Hospitals and Clinics of Minnesota - Minneapolis
		Clinical Trials Office - Children's Hospitals and Clinics of Minnesota	Ph:  612-813-5193
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Gail Megason	Ph:  601-984-5220
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Clinical Trial Office - Ellis Fischel Cancer Center	Ph:  573-882-7440
	Kansas City
	Children's Mercy Hospital
		Maxine Hetherington	Ph:  816-234-3265
Nevada
	Las Vegas
		Jonathan Bernstein	Ph:  702-732-1493
	CCOP - Nevada Cancer Research Foundation
		Jonathan Bernstein	Ph:  702-732-0971
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu
New Jersey
	Hackensack
	Hackensack University Medical Center Cancer Center
		Clinical Trials Office - Hackensack University Medical Center Cancer Center	Ph:  201-996-2879
	Morristown
	Overlook Hospital
		Hazem Mahmoud	Ph:  973-971-6720
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Clinical Trials Office - Cancer Institute of New Jersey	Ph:  732-235-8675
	Saint Peter's University Hospital
		Douglas Cipkala	Ph:  732-745-6674
	Newark
	Newark Beth Israel Medical Center
		Clinical Trials Office - Newark Beth Israel Medical Center	Ph:  973-926-3136
	Paterson
	St. Joseph's Hospital and Medical Center
		Mary Bonilla	Ph:  973-754-3349
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
New York
	Bronx
	Albert Einstein Cancer Center at Albert Einstein College of Medicine
		Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine	Ph:  718-904-2730
			Email: aecc@aecom.yu.edu
	Brooklyn
	Brooklyn Hospital Center
		Swayamprabha Sadanandan	Ph:  718-250-6074
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	Mineola
	Winthrop University Hospital
		Contact Person	Ph:  516-663-9500
	New Hyde Park
	Schneider Children's Hospital
		Arlene Redner	Ph:  718-470-3460
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	Ph:  212-305-8615
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Barbara Asselin	Ph:  585-275-2981
	Stony Brook
	Stony Brook University Cancer Center
		Clinical Trials Office - Stony Brook University Cancer Center	Ph:  800-862-2215
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
	Valhalla
	New York Medical College
		Fevzi Ozkaynak	Ph:  914-493-7997
North Carolina
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
	Durham
	Duke Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph:  888-275-3853
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
North Dakota
	Fargo
	CCOP - MeritCare Hospital
		Nathan Kobrinsky	Ph:  701-234-7544
Ohio
	Akron
	Akron Children's Hospital
		Clinical Trials Office - Akron Children's Hospital	Ph:  330-543-3193
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	Rainbow Babies and Children's Hospital
		Yousif (Joe) Matloub	Ph:  216-844-3345
	Columbus
	Nationwide Children's Hospital
		Amanda Termuhlen	Ph:  614-722-3552
	Dayton
	Children's Medical Center - Dayton
		Emmett Broxson	Ph:  937-641-3111
	Toledo
	Medical University of Ohio Cancer Center
		Clinical Trials Office - Medical University of Ohio Cancer Center	Ph:  419-383-6583
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Rene McNall-Knapp	Ph:  405-271-5311
Oregon
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University	Ph:  503-494-1080
			Email: trials@ohsu.edu
	Legacy Emanuel Hospital and Health Center and Children's Hospital
		Clinical Trials Office - Legacy Emanuel Hospital and Health Center and Children's Hospital	Ph:  503-413-8199
Pennsylvania
	Bethlehem
	Lehigh Valley Hospital - Muhlenberg
		Philip Monteleone	Ph:  484-884-3333
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu
	Philadelphia
	Children's Hospital of Philadelphia
		Richard Aplenc	Ph:  267-426-7252
	St. Christopher's Hospital for Children
		Clinical Trials Office - St. Christopher's Hospital for Children	Ph:  215-427-8991
	Pittsburgh
	Children's Hospital of Pittsburgh
		Clinical Trials Office - Children's Hospital of Pittsburgh	Ph:  412-692-5573
Rhode Island
	Providence
	Rhode Island Hospital Comprehensive Cancer Center
		Clinical Trials Office - Rhode Island Hospital Comprehensive Cancer Center	Ph:  401-444-1488
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
	Greenville
	Greenville Hospital Cancer Center
		Clinical Trials Office - Greenville Hospital Cancer Center	Ph:  864-241-6251
South Dakota
	Sioux Falls
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Tennessee
	Chattanooga
	T.C. Thompson Children's Hospital
		Manoo Bhakta	Ph:  423-778-7289
	Knoxville
	East Tennessee Children's Hospital
		Ray Pais	Ph:  865-541-8266
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  800-811-8480
Texas
	Amarillo
	Texas Tech University Health Sciences Center School of Medicine - Amarillo
		Curtis Turner	Ph:  806-354-5434X264
	Corpus Christi
	Driscoll Children's Hospital
		Clinical Trials Office - Driscoll Children's Hospital	Ph:  361-694-5311
	Dallas
	Medical City Dallas Hospital
		Carl Lenarsky	Ph:  972-566-6647x4439
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097
	Fort Worth
	Cook Children's Medical Center - Fort Worth
		Clinical Trials Office - Cook's Children's Medical Center	Ph:  682-885-2103
	Houston
	Baylor University Medical Center - Houston
		Patrick Thompson	Ph:  832-824-4029
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
	San Antonio
	Methodist Children's Hospital of South Texas
		Michael Grimley	Ph:  210-575-7268
	University of Texas Health Science Center at San Antonio
		Paul Thomas	Ph:  210-704-2187
Utah
	Salt Lake City
	Primary Children's Medical Center
		Phillip Barnette	Ph:  801-662-4700
Vermont
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Virginia
	Falls Church
	Inova Fairfax Hospital
		Clinical Trials Office - Inova Fairfax Hospital	Ph:  703-208-6650
	Roanoke
	Carilion Medical Center for Children at Roanoke Community Hospital
		Mandy Atkinson	Ph:  540-981-7376
Washington
	Spokane
	Providence Cancer Center at Sacred Heart Medical Center
		Judy Felgenhauer	Ph:  509-474-2777
West Virginia
	Charleston
	West Virginia University Health Sciences Center - Charleston
		Allen Chauvenet	Ph:  304-388-1552
	Morgantown
	Mary Babb Randolph Cancer Center at West Virginia University Hospitals
		Contact Person	Ph:  304-293-4500 877-427-2894
Wisconsin
	Green Bay
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Milwaukee
	Midwest Children's Cancer Center at Children's Hospital of Wisconsin
		Michael Kelly	Ph:  414-456-4170
Australia
Queensland
	Brisbane
	Royal Children's Hospital
		Helen Irving	Ph:  617-3636-8671
Western Australia
	Perth
	Princess Margaret Hospital for Children
		Catherine Cole	Ph:  011-6189340-8238
Canada
	Quebec
	Centre Hospitalier Universitaire de Quebec
		Bruno Michon	Ph:  418-656-4141X47191
Alberta
	Edmonton
	University of Alberta Hospital
		Sunil Jayantilal` Desai	Ph:  780-407-8829
British Columbia
	Vancouver
	Children's & Women's Hospital of British Columbia
		Mason Bond	Ph:  604-875-2322
Manitoba
	Winnipeg
	CancerCare Manitoba
		Rochelle Yanofsky	Ph:  204-787-4163
Newfoundland and Labrador
	St. John's
	Janeway Children's Health and Rehabilitation Centre
		John (Jack) Hand	Ph:  709-777-4799
Nova Scotia
	Halifax
	IWK Health Centre
		Margaret Yhap	Ph:  902-470-8778
Ontario
	Hamilton
	McMaster Children's Hospital at Hamilton Health Sciences
		Carol Portwine	Ph:  905-521-2100x73464
	Kingston
	Cancer Centre of Southeastern Ontario at Kingston General Hospital
		Mariana Silva	Ph:  613-5496666x3833
	Ottawa
	Children's Hospital of Eastern Ontario
		Jacqueline Halton	Ph:  613-737-7600x2370
Quebec
	Montreal
		Yvan Samson	Ph:  514-345-4969
	Hopital Sainte Justine
		Yvan Samson	Ph:  418-656-4141x47191
Saskatchewan
	Regina
	Allan Blair Cancer Centre at Pasqua Hospital
		Mansoor Haq	Ph:  306-766-2498
	Saskatoon
	Saskatoon Cancer Centre at the University of Saskatchewan
		Kaiser Ali	Ph:  306-655-2744
New Zealand
	Auckland
	Starship Children's Health
		Lochie Teague	Ph:  64930749496368
	Christchurch
	Christchurch Hospital
		Robin Corbett	Ph:  643364-0740
Switzerland
	Bern
	Swiss Pediatric Oncology Group Bern
		Roland Ammann	Ph:  41316329372
	Geneva
	Swiss Pediatric Oncology Group Geneva
		Hulya Ozsahin	Ph:  0041223824712
	Lausanne
	Swiss Pediatric Oncology Group Lausanne
		Maja Beck Popovic	Ph:  41213141111x3567

Registry Information
Official Title		Treatment of Isolated Extramedullary Relapse from Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 months)
Trial Start Date		2008-09-02
Trial Completion Date		2008-11-25 (estimated)
Registered in ClinicalTrials.gov		NCT00096135
Date Submitted to PDQ		2004-09-01
Information Last Verified		2009-11-06
NCI Grant/Contract Number		CA98543

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