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A Phase III Group-Wide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease


Phase 3
N/A
21 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase III Group-Wide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease


OBJECTIVES:

- Compare response-based therapy with doxorubicin, bleomycin, vincristine, etoposide,
prednisone, and cyclophosphamide with or without dexamethasone, etoposide, cytarabine,
cisplatin, and/or radiotherapy in children with intermediate-risk Hodgkin's lymphoma.

- Determine whether radiotherapy can be eliminated from this regimen based upon early and
complete response to multiagent chemotherapy in these patients.

- Determine whether the addition of dexamethasone, etoposide, cytarabine, cisplatin, and
filgrastim (G-CSF) improves outcome in those patients with a slow early response to
standard chemotherapy.

- Compare the frequency and severity of late effects of this therapy, including thyroid
dysfunction, infertility, cardiotoxicity, pulmonary toxicity, and second malignant
neoplasms, in patients treated with these regimens.

- Correlate results from biology and late effects studies with response to therapy,
event-free survival, and overall survival in these patients.

OUTLINE: This is a randomized, multicenter study.

- Initial chemotherapy (ABVE-PC): Patients receive doxorubicin IV over 10-30 minutes on
days 1-2, bleomycin IV over 10-20 minutes or subcutaneously (SC) and vincristine IV on
days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily
on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim
(G-CSF) SC beginning on day 4 and continuing until blood counts recover (G-CSF is held
on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive
disease.

At the end of initial chemotherapy, patients undergo evaluation for response. Patients with
less than 60% disease reduction are considered to have slow early response (SER). Patients
with 60% or more disease reduction are considered to have rapid early response (RER).

- RER: Patients with RER receive 2 additional courses of ABVE-PC chemotherapy. After the
additional course, patients with less than a complete response undergo radiotherapy 5
days a week. Patients with a complete response are randomized to receive either
radiotherapy or no further treatment.

- SER: Patients with SER are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3
hours, and cytarabine IV over 3 hours on days 1-2 and cisplatin IV over 6 hours on
day 1. Patients also receive G-CSF SC beginning on day 3 and continuing until
blood counts recover. Treatment repeats every 21 days for 2 courses in the absence
of disease progression or unacceptable toxicity. After these 2 courses, patients
then receive 2 additional courses of ABVE-PC chemotherapy. Patients then undergo
radiotherapy.

- Arm II: Patients receive 2 additional courses of ABVE-PC chemotherapy. Patients
then undergo radiotherapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study within 5-5.5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed Hodgkin's lymphoma

- All histologies eligible

- Stage IB or IIB

- Stage IA with bulk disease

- Stage IIA with bulk disease

- Stage IIAE

- Stage IIIA

- Stage IVA

- May not be staged by laparotomy alone

- Surgically staged patients must also have presurgical staging

PATIENT CHARACTERISTICS:

Age:

- 21 and under

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 1.5 times normal

- SGOT or SGPT less than 2.5 times normal

Renal:

- Creatinine no greater than 1.5 times normal

- Creatinine clearance greater than 40 mL/min OR

- Radioisotope glomerular filtration rate greater than 70 mL/min

Cardiovascular:

- Shortening fraction at least 27% by echocardiogram OR

- Ejection fraction at least 50% by MUGA

- No pathologic prolongation of QTc interval on 12-lead electrocardiogram

Pulmonary:

- FEV_1/FVC greater than 60% by pulmonary function test OR

- Pulse oximetry greater than 94% AND

- No evidence of dyspnea at rest AND

- No exercise intolerance

Other:

- Adequate venous access

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- At least 1 month since prior corticosteroids except prednisone for respiratory
distress

Radiotherapy:

- No prior radiotherapy

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Outcome Description:

Event-free survival defined as the time to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Debra L. Friedman, MD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

Seattle Children's Hospital

Authority:

United States: Federal Government

Study ID:

AHOD0031

NCT ID:

NCT00025259

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • stage II childhood Hodgkin lymphoma
  • stage I childhood Hodgkin lymphoma
  • stage III childhood Hodgkin lymphoma
  • stage IV childhood Hodgkin lymphoma
  • childhood lymphocyte predominant Hodgkin lymphoma
  • childhood lymphocyte depletion Hodgkin lymphoma
  • childhood nodular sclerosis Hodgkin lymphoma
  • childhood mixed cellularity Hodgkin lymphoma
  • childhood nodular lymphocyte predominant Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
Hurley Medical Center Flint, Michigan  48503
Medical City Dallas Hospital Dallas, Texas  75230
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington, Connecticut  06360-2875
Baystate Regional Cancer Program at D'Amour Center for Cancer Care Springfield, Massachusetts  01199
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Newark Beth Israel Medical Center Newark, New Jersey  07112
New York Medical College Valhalla, New York  10595
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
CCOP - Scott and White Hospital Temple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Sutter Cancer Center Sacramento, California  95816
Children's Hospital of Orange County Orange, California  92668
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
St. Joseph's Hospital and Medical Center Paterson, New Jersey  07503
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
University of California Davis Cancer Center Sacramento, California  95817
Nemours Children's Clinic Jacksonville, Florida  32207
Miami Children's Hospital Miami, Florida  33155-4069
All Children's Hospital St. Petersburg, Florida  33701
Children's Memorial Hospital - Chicago Chicago, Illinois  60614
Saint Jude Midwest Affiliate Peoria, Illinois  61637
Children's Hospital of New Orleans New Orleans, Louisiana  70118
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
Schneider Children's Hospital New Hyde Park, New York  11042
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Driscoll Children's Hospital Corpus Christi, Texas  78466
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
City of Hope Comprehensive Cancer Center Duarte, California  91010
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Southern California Permanente Medical Group Downey, California  90242
Children's Hospital Central California Madera, California  93638-8762
Kosair Children's Hospital Louisville, Kentucky  40202-3830
Children's Medical Center - Dayton Dayton, Ohio  45404
Palmetto Health South Carolina Cancer Center Columbia, South Carolina  29203
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Covenant Children's Hospital Lubbock, Texas  79410
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Midwest Children's Cancer Center at Children's Hospital of Wisconsin Milwaukee, Wisconsin  53226
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Overlook Hospital Summit, New Jersey  07902-0220
Winthrop University Hospital Mineola, New York  11501
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach, California  90801
Kaiser Permanente Medical Center - Oakland Sacramento, California  95825
Santa Barbara Cottage Children's Hospital Santa Barbara, California  93105
Yale Cancer Center New Haven, Connecticut  06520-8028
Lee Cancer Care of Lee Memorial Health System Fort Myers, Florida  33901
Broward General Medical Center Cancer Center Ft. Lauderdale, Florida  33316
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer Program Miami, Florida  33176
Nemours Children's Clinic - Orlando Orlando, Florida  32806
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando, Florida  32803-1273
Sacred Heart Cancer Center at Sacred Heart Hospital Pensacola, Florida  32504
St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical Center West Palm Beach, Florida  33407
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Advocate Christ Medical Center Oak Lawn, Illinois  60453
St. Vincent Indianapolis Hospital Indianapolis, Indiana  46260
Blank Children's Hospital Des Moines, Iowa  50309
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore, Maryland  21215
Floating Hospital for Children at Tufts - New England Medical Center Boston, Massachusetts  02111
Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
Hackensack University Medical Center Cancer Center Hackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
NYU Cancer Institute at New York University Medical Center New York, New York  10016
Mount Sinai Medical Center New York, New York  10029
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Mission Hospitals - Memorial Campus Asheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Rainbow Babies and Children's Hospital Cleveland, Ohio  44106-5000
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
Rhode Island Hospital Comprehensive Cancer Center Providence, Rhode Island  02903
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Texas Tech University Health Sciences Center School of Medicine - Amarillo Amarillo, Texas  79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Baylor University Medical Center - Houston Houston, Texas  77030-2399
Methodist Children's Hospital of South Texas San Antonio, Texas  78229-3993
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
Naval Medical Center - Portsmouth Portsmouth, Virginia  23708-2197
Providence Cancer Center at Sacred Heart Medical Center Spokane, Washington  99220-2555
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Saint Peter's University Hospital New Brunswick, New Jersey  08901-1780
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
Memorial Cancer Institute at Memorial Regional Hospital Hollywood, Florida  33021
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles, California  90048-1865
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Childrens Hospital Los Angeles Los Angeles, California  90027
Children's Hospital and Research Center Oakland Oakland, California  94609
Rady Children's Hospital - San Diego San Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Children's Hospital Center for Cancer and Blood Disorders Aurora, Colorado  80045
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
M.D. Anderson Cancer Center at Orlando Orlando, Florida  32806
MBCCOP - Medical College of Georgia Cancer Center Augusta, Georgia  30912-3730
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise, Idaho  83712-6297
University of Illinois Cancer Center Chicago, Illinois  60612-7243
Advocate Lutheran General Cancer Care Center Park Ridge, Illinois  60068-1174
Simmons Cooper Cancer Institute Springfield, Illinois  62794-9677
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Tulane Cancer Center Office of Clinical Research Alexandria, Louisiana  71315-3198
CancerCare of Maine at Eastern Maine Medical Center Bangor, Maine  04401
C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor, Michigan  48109-0286
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota  55404
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Children's Hospital Omaha, Nebraska  68114-4113
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Albany Medical Center Hospital Albany, New York  12208-3419
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York, New York  10032
Akron Children's Hospital Akron, Ohio  44308-1062
Nationwide Children's Hospital Columbus, Ohio  43205-2696
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Knight Cancer Institute at Oregon Health and Science University Portland, Oregon  97239-3098
Legacy Emanuel Hospital and Health Center and Children's Hospital Portland, Oregon  97227
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Dell Children's Medical Center of Central Texas Austin, Texas  78723
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Carilion Medical Center for Children at Roanoke Community Hospital Roanoke, Virginia  24014
Madigan Army Medical Center - Tacoma Tacoma, Washington  98431
Mary Bridge Children's Hospital and Health Center - Tacoma Tacoma, Washington  98405
West Virginia University Health Sciences Center - Charleston Charleston, West Virginia  25302
University of Virginia Cancer Center Charlottesville, Virginia  22908
UAB Comprehensive Cancer Center Birmingham, Alabama  35294
Stanford Cancer Center Stanford, California  94305-5824
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136
Leo W. Jenkins Cancer Center at ECU Medical School Greenville, North Carolina  27834
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania  18017
Greenville Hospital Cancer Center Greenville, South Carolina  29605
T.C. Thompson Children's Hospital Chattanooga, Tennessee  37403
Banner Desert Medical Center Mesa, Arizona  85202