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

Alternate Title

Isotretinoin With or Without Monoclonal Antibody, Interleukin-2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	30 and under at diagnosis	NCI	COG-ANBL0032 ANBL0032, COG-P9842, NCT00026312

Objectives

Primary

1. Compare the event-free survival of patients with neuroblastoma who have completed myeloablative therapy and autologous stem cell transplantation (ASCT) when treated with adjuvant isotretinoin with or without monoclonal antibody Ch14.18, interleukin-2, and sargramostim (GM-CSF).

Secondary

1. Compare the overall survival of patients treated with these regimens.
2. Compare the event-free survival of the subgroup of high-risk, stage IV patients treated with these regimens.
3. Compare the reduction of minimal residual disease (MRD) in patients treated with these regimens.
4. Determine whether change from baseline MRD is associated with event-free and overall survival in patients treated with these regimens.
5. Determine whether tumor biology at diagnosis correlates with event-free and overall survival in patients treated with these regimens.
6. Determine the toxic effects of this combination regimen in these patients.
7. Determine whether antibody-dependent cellular cytotoxicity correlates with event-free survival in patients treated with these regimens.
8. Determine the descriptive profile of human anti-chimeric antibody (HACA) during immunotherapy.
9. Compare outcome data of patients with persistent disease with historical data after being treated with these regimens.
10. Correlate the pharmacokinetics and pharmacogenomic parameters with event-free survival or systemic toxicity.
11. Further describe and refine the event-free survival and overall survival estimates and baseline characteristics for patients treated with isotretinoin, monoclonal antibody Ch14.18, and interleukin-2 following cessation of the randomized portion of the study.
12. Further describe the safety and toxicity of isotretinoin, monoclonal antibody Ch14.18, and interleukin-2 in these patients following cessation of the randomized portion of the study including the number of courses delivered per patient, the number of dose reductions or stoppage (CH14.18 and/or interleukin-2) and the number of toxic deaths.

Entry Criteria

Disease Characteristics:

• Diagnosis of neuroblastoma
  • Categorized as high risk at diagnosis



• Meets all of the following criteria:
  • Patients much have completed therapy including intensive induction followed by autologous stem cell transplantation (ASCT) and radiotherapy
  • Completed frontline therapies, examples of such therapy includes:
    • Following treatment per COG-A3973 protocol
    • Following treatment per POG-9340-42
    • Following treatment per CCG-3891
    • Following treatment on NANT-2001-02
    • Enrollment on or following treatment per COG-ANBL02P1 protocol
    • Enrollment on or following treatment per ANBL07P1
    • Tandem transplant patients are eligible
      • Following enrollment and treatment on or per COG-ANBL0532
      • Following treatment per POG-9640 protocol
      • Following treatment per COG-ANBL00P1 protocol
      • Following treatment per CHP 594 or DFCI 34-DAT
    • Other frontline therapy with permission from study chairs
  • Patients with biopsy confirmed residual disease after ASCT are eligible



• Must meet the International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases, and bone metastases AND must also meet the protocol specified criteria for bone marrow response as follows:
  • No more than 10% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy
  • Patient who have no tumor seen on the prior bone marrow, and then have ≤ 10% tumor on any of the bilateral marrow aspirate/biopsy specimens done at pre-ASCT and/or pre-enrollment evaluation will also be eligible



• No more than 9 months from starting the first induction chemotherapy after diagnosis to the date of ASCT *



• No progressive disease at time of registration except for protocol specified bone marrow response

 [Note: * For tandem ASCT patients this is the date of the first stem cell infusion]

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• No more than 1 prior stem cell transplantation
• No other concurrent cytokines or growth factors (e.g., filgrastim [G-CSF] or interferon)
• No IV immunoglobulin G within 2 weeks before, during, and for 1 week after monoclonal antibody Ch14.18 (arm II patients)
• No prior anti-GD2 antibody therapy

Chemotherapy:

• No more than 1 prior myeloablative consolidation regimen
• No concurrent myelosuppressive chemotherapy (arm II patients)

Endocrine therapy:

• No concurrent corticosteroids unless for life-threatening conditions (e.g., increased intracranial pressure from CNS tumors or life-threatening allergic reactions)

Radiotherapy:

• See Disease Characteristics
• At least 7 days since prior radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent anticancer therapy
• No concurrent immunosuppressive drugs (e.g., cyclosporine)
• No concurrent pentoxifylline
• No radiographic contrast materials during and for at least 1 week after interleukin-2 (arm II)

Patient Characteristics:

Age:

• 30 and under at diagnosis

Performance status:

• Lansky 50-100%

  OR

• Karnofsky 50-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• Total absolute phagocyte count (neutrophils and monocytes) ≥ 1,000/mm³

Hepatic:

• Bilirubin ≤ 1.5 times normal
• SGPT ≤ 5 times normal
• Veno-occlusive disease (if present) stable or improving

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 ≥ 30% by echocardiogram

  OR

• Ejection fraction ≥ 55% by MUGA

Pulmonary:

• FEV₁ and FVC > 60% predicted by pulmonary function test

  OR

• No evidence of dyspnea at rest, no exercise intolerance

Other:

• Not pregnant
• Fertile patients must use effective contraception
• Seizure disorder allowed if well-controlled and on anticonvulsants
• CNS toxicity < grade 2

Expected Enrollment

A total of 423 patients will be accrued for this study within 5 years.

Outcomes

Event-free survival (EFS)

Overall survival (OS)
Reduction of minimal residual disease (MRD)
Association between change from baseline MRD and EFS and OS
Correlation of tumor biology at diagnosis with EFS and OS
Toxic effects
Correlation of antibody-dependent cellular cytotoxicity with event-free survival
Comparison of outcome of patients with persistent disease with historical data
Correlation of pharmacokinetic and pharmacogenomic parameters with EFS or systemic toxicity

Outline

This is a randomized, multicenter study. Patients are stratified according to pre-autologous stem cell transplantation (ASCT) response (complete vs very good partial vs partial), stem cells received (purged vs unpurged), and frontline chemotherapy (COG-A3973 vs POG 9341/9342 vs COG-ANGL02P1 vs other therapy). A further stratum consists of patients with biopsy-confirmed post-ASCT persistent disease who are also enrolled on COG-A3973 or COG-ANBL0532. These patients are not randomized but assigned to treatment arm II. Patients in the first set of strata are randomized to 1 of 2 treatment arms.

• Arm I (closed to accrual as of 4/16/2009): Beginning on day 67 post-ASCT, patients receive oral isotretinoin twice daily for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients may cross over to Arm II provided they have not experienced disease progression and have not received any further anti-neuroblastoma therapy following completion of isotretinoin therapy.



• Arm II: Beginning on day 56 post-ASCT, patients receive immunotherapy comprising sargramostim (GM-CSF) subcutaneously (SC) or IV over 2 hours on days 0-13 during courses 1, 3, and 5 and monoclonal antibody Ch14.18 IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive interleukin-2 IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral isotretinoin as in arm I beginning on day 11 of immunotherapy.

Patients are followed periodically for 10 years.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Alice Yu, MD, PhD, Protocol chair		Ph: 858-822-5354

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Clinical Trials Office - Lurleen Wallace Comprehensive Cancer	Ph:  205-934-0309
California
	Downey
	Southern California Permanente Medical Group
		Robert Cooper	Ph:  323-783-5307
	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
	Childrens Hospital Los Angeles
		Leo Mascarenhas	Ph:  323-361-2529
	Sacramento
	Kaiser Permanente Medical Center - Oakland
		Vincent Kiley	Ph:  916-474-2326
	San Diego
	Rady Children's Hospital - San Diego
		Clinical Trials Office - Rady Children's Hospital - San Diego	Ph:  858-966-5934
	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
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
	Miami Children's Hospital
		Enrique Escalon	Ph:  305-662-8360x4960
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clinical Trials Office - Florida Hospital Cancer Institute	Ph:  407-303-5623
	M.D. Anderson Cancer Center at Orlando
		Vincent Giusti	Ph:  321-841-8588
	St. Petersburg
	All Children's Hospital
		Gregory Hale	Ph:  727-767-4176
	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
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
Illinois
	Chicago
	Children's Memorial Hospital - Chicago
		Stewart Goldman	Ph:  773-880-4598x3270
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	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
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
Louisiana
	New Orleans
	Children's Hospital of New Orleans
		Clinical Trials Office - Children's Hospital of New Orleans	Ph:  504-894-5377
Maryland
	Baltimore
	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
		Joseph Wiley	Ph:  410-601-5864
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Suzanne Shusterman	Ph:  617-632-4901
	Springfield
	Baystate Regional Cancer Program at D'Amour Center for Cancer Care
		Satkiran Grewal	Ph:  413-794-5316
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
	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
	Lansing
	Breslin Cancer Center at Ingham Regional Medical Center
		Clinical Trials Office - Breslin Cancer Center at Ingham Regional Medical Center	Ph:  517-334-2765
Minnesota
	Minneapolis
	Children's Hospitals and Clinics of Minnesota - Minneapolis
		Clinical Trials Office - Children's Hospitals and Clinics of Minnesota	Ph:  612-813-5193
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
Missouri
	St. Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Robert Hayashi	Ph:  314-454-4118
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
	New Brunswick
	Saint Peter's University Hospital
		Doug Cipkala	Ph:  732-745-6674
New York
	Albany
	Albany Medical Center Hospital
		Vikramjit Kanwar	Ph:  518-262-5513x25265
	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
	New York
	Mount Sinai Medical Center
		Birte Wistinghausen	Ph:  212-241-7022
	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
	Asheville
	Mission Hospitals - Memorial Campus
		Clinical Trials Office - Mission Hospitals - Memorial Campus	Ph:  828-213-4150
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Charlotte
	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
Ohio
	Akron
	Akron Children's Hospital
		Clinical Trials Office - Akron Children's Hospital	Ph:  330-543-3193
	Cincinnati
	Cincinnati Children's Hospital Medical Center
		Clinical Trials Office - Cincinnati Children's Hospital Medical Center	Ph:  513-636-2799
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	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:  484-884-3347
	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
Rhode Island
	Providence
	Rhode Island Hospital Comprehensive Cancer Center
		Clinical Trials Office - Rhode Island Hospital Comprehensive Cancer Center	Ph:  401-444-1488
South Carolina
	Columbia
	Palmetto Health South Carolina Cancer Center
		Clinical Trials Office - Palmetto Health South Carolina Cancer Center	Ph:  803-434-3680
Tennessee
	Knoxville
	East Tennessee Children's Hospital
		Ray Pais	Ph:  865-541-8266
	Memphis
	St. Jude Children's Research Hospital
		Clinical Trials Office - St. Jude Children's Research Hospital	Ph:  901-595-4644
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  1-800-811-8480;
Texas
	Austin
	Dell Children's Medical Center of Central Texas
		Clinical Trials Office - Dell Children's Medical Center of Central Texas	Ph:  512-324-8022
	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
	Lubbock
	Covenant Children's Hospital
		Latha Prasannan	Ph:  806-725-4840
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
	Norfolk
	Children's Hospital of The King's Daughters
		Eric Lowe	Ph:  757-668-7243
Washington
	Seattle
	Children's Hospital and Regional Medical Center - Seattle
		Julie Park	Ph:  206-987-1947
	Spokane
	Providence Cancer Center at Sacred Heart Medical Center
		Judy Felgenhauer	Ph:  509-474-2777
Wisconsin
	Green Bay
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Milwaukee
	Midwest Children's Cancer Center at Children's Hospital of Wisconsin
		Bruce Camitta	Ph:  414-456-4106
Australia
New South Wales
	Westmead
	Westmead Institute for Cancer Research at Westmead Hospital
		Geoffrey McCowage	Ph:  61298452122
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
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
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
	London
	Children's Hospital of Western Ontario
		A. Cairney	Ph:  519-685-8494
	Ottawa
	Children's Hospital of Eastern Ontario
		Jacqueline Halton	Ph:  613-737-7600x2370
	Toronto
	Hospital for Sick Children
		Sylvain Baruchel	Ph:  416-813-7795
Quebec
	Montreal
		Yvan Samson	Ph:  514-345-4969
	Hopital Sainte Justine
		Yvan Samson	Ph:  418-656-4141x47191
	Montreal Children's Hospital at McGill University Health Center
		Sharon Abish	Ph:  514-412-4400x22219
Saskatchewan
	Saskatoon
	Saskatoon Cancer Centre at the University of Saskatchewan
		Kaiser Ali	Ph:  306-655-2744

Related Information

PDQ® clinical trial COG-A3973
PDQ® clinical trial COG-ANBL02P1
PDQ® clinical trial CCG-3891
PDQ® clinical trial NANT-2001-02
PDQ® clinical trial COG-ANBL0532
PDQ® clinical trial POG-9340-42

Registry Information
Official Title		Phase III Randomized Study Of Chimeric Antibody 14.18 (CH14.18) In High Risk Neuroblastoma Following Myeloablative Therapy And Autologous Stem Cell Rescue
Trial Start Date		2001-10-18
Trial Completion Date		2012-06-01 (estimated)
Registered in ClinicalTrials.gov		NCT00026312
Date Submitted to PDQ		2001-09-14
Information Last Verified		2009-07-02
NCI Grant/Contract Number		CA30969

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