Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring anaplastic large cell lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Newly diagnosed advanced anaplastic large cell lymphoma Cluster of differentiation antigen 30 (CD30+) Murphy stage III or IV No B-cell large cell lymphoma No disease limited to the skin (regardless of how wide-spread) PATIENT CHARACTERISTICS: Age Under 21 Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) Aspartate aminotransferase (AST) or alanine transaminase (ALT) less than 2.5 times ULN (unless due to lymphoma) Renal Not specified Cardiovascular Shortening fraction (SF) at least 27% by echocardiogram OR Ejection fraction (EF) at least 50% by radionuclide angiogram Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Prior steroids for management of a mediastinal mass allowed Radiotherapy Prior limited-dose radiotherapy for a mediastinal mass allowed Surgery Not specified
Sites / Locations
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
- Phoenix Children's Hospital
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Children's Hospital Central California
- Children's Hospital of Orange County
- Sutter Cancer Center
- Kaiser Permanente Medical Center - Oakland
- Rady Children's Hospital - San Diego
- UCSF Helen Diller Family Comprehensive Cancer Center
- Stanford Cancer Center
- Children's Hospital Center for Cancer and Blood Disorders
- Presbyterian - St. Luke's Medical Center
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Alfred I. duPont Hospital for Children
- Children's National Medical Center
- Broward General Medical Center Cancer Center
- Lee Cancer Care of Lee Memorial Health System
- Memorial Cancer Institute at Memorial Regional Hospital
- Nemours Children's Clinic
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- Miami Children's Hospital
- Baptist-South Miami Regional Cancer Program
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- M.D. Anderson Cancer Center at Orlando
- Sacred Heart Cancer Center at Sacred Heart Hospital
- All Children's Hospital
- St. Joseph's Cancer Institute at St. Joseph's Hospital
- Kaplan Cancer Center at St. Mary's Medical Center
- Winship Cancer Institute of Emory University
- MBCCOP - Medical College of Georgia Cancer Center
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Cancer Research Center of Hawaii
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- Children's Memorial Hospital - Chicago
- University of Chicago Cancer Research Center
- Advocate Christ Medical Center
- Advocate Lutheran General Cancer Care Center
- Saint Jude Midwest Affiliate
- Simmons Cooper Cancer Institute
- Indiana University Melvin and Bren Simon Cancer Center
- St. Vincent Indianapolis Hospital
- Blank Children's Hospital
- Holden Comprehensive Cancer Center at University of Iowa
- Lucille P. Markey Cancer Center at University of Kentucky
- Kosair Children's Hospital
- Tulane Cancer Center Office of Clinical Research
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- Floating Hospital for Children at Tufts - New England Medical Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
- C.S. Mott Children's Hospital at University of Michigan Medical Center
- Barbara Ann Karmanos Cancer Institute
- Hurley Medical Center
- Butterworth Hospital at Spectrum Health
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- CCOP - Kalamazoo
- Breslin Cancer Center at Ingham Regional Medical Center
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- Masonic Cancer Center at University of Minnesota
- Mayo Clinic Cancer Center
- University of Mississippi Cancer Clinic
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Children's Mercy Hospital
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Children's Hospital
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- CCOP - Nevada Cancer Research Foundation
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Hackensack University Medical Center Cancer Center
- Overlook Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Newark Beth Israel Medical Center
- St. Joseph's Hospital and Medical Center
- University of New Mexico Cancer Center
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- Brooklyn Hospital Center
- Roswell Park Cancer Institute
- Schneider Children's Hospital
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- SUNY Upstate Medical University Hospital
- New York Medical College
- Mission Hospitals - Memorial Campus
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Duke Comprehensive Cancer Center
- Leo W. Jenkins Cancer Center at ECU Medical School
- Wake Forest University Comprehensive Cancer Center
- CCOP - MeritCare Hospital
- Akron Children's Hospital
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Children's Hospital
- Cleveland Clinic Taussig Cancer Center
- Nationwide Children's Hospital
- Children's Medical Center - Dayton
- Toledo Hospital
- Medical University of Ohio Cancer Center
- Oklahoma University Cancer Institute
- Legacy Emanuel Hospital and Health Center and Children's Hospital
- Oregon Health and Science University Cancer Institute
- Lehigh Valley Hospital - Muhlenberg
- Geisinger Cancer Institute at Geisinger Health
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- St. Christopher's Hospital for Children
- Children's Hospital of Pittsburgh
- Rhode Island Hospital Comprehensive Cancer Center
- Greenville Hospital Cancer Center
- Sanford Cancer Center at Sanford USD Medical Center
- T.C. Thompson Children's Hospital
- East Tennessee Children's Hospital
- St. Jude Children's Research Hospital
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
- Dell Children's Medical Center of Central Texas
- Driscoll Children's Hospital
- Medical City Dallas Hospital
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Cook Children's Medical Center - Fort Worth
- Baylor University Medical Center - Houston
- M. D. Anderson Cancer Center at University of Texas
- Covenant Children's Hospital
- University of Texas Health Science Center at San Antonio
- Methodist Children's Hospital of South Texas
- Primary Children's Medical Center
- Fletcher Allen Health Care - University Health Center Campus
- Children's Hospital of The King's Daughters
- Virginia Commonwealth University Massey Cancer Center
- Carilion Medical Center for Children at Roanoke Community Hospital
- Children's Hospital and Regional Medical Center - Seattle
- Providence Cancer Center at Sacred Heart Medical Center
- Mary Bridge Children's Hospital and Health Center - Tacoma
- West Virginia University Health Sciences Center - Charleston
- St. Vincent Hospital Regional Cancer Center
- Marshfield Clinic - Marshfield Center
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
- Westmead Institute for Cancer Research at Westmead Hospital
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- University of Alberta Hospital
- Children's & Women's Hospital of British Columbia
- CancerCare Manitoba
- Janeway Children's Health and Rehabilitation Centre
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Children's Hospital of Western Ontario
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
- Allan Blair Cancer Centre at Pasqua Hospital
- Saskatoon Cancer Centre at the University of Saskatchewan
- Centre Hospitalier Universitaire de Quebec
- San Jorge Children's Hospital
- Swiss Pediatric Oncology Group Bern
- Swiss Pediatric Oncology Group Geneva
- Swiss Pediatric Oncology Group Lausanne
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Standard APO with Vincristine (Arm I )
Consolidation with Vinblastine
In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.