Know Cancer

or
forgot password

Protocol for Patients With Newly Diagnosed Better Risk Acute Lymphoblastic Leukemia (ALL): A POG Pilot Study


Phase 2
N/A
18 Years
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

Protocol for Patients With Newly Diagnosed Better Risk Acute Lymphoblastic Leukemia (ALL): A POG Pilot Study


OBJECTIVES: I. Determine whether a delayed multidrug intensification can be given in
conjunction with methotrexate and leucovorin calcium rescue consolidation therapy in
children with average risk acute lymphocytic leukemia. II. Determine the feasibility of
delivering 6 courses of this therapy in these patients.

OUTLINE: This is a multicenter study. Induction: Patients receive oral dexamethasone twice
daily on days 1-29, vincristine IV on days 1, 8, 15, and 22, and asparaginase
intramuscularly (IM) on days 2, 5, 8, 12, 15, and 19. Patients receive methotrexate
intrathecally (IT) on days 1 and 15. CNS 2 and 3 patients also receive methotrexate IT on
days 8 and 22. Patients with M1 bone marrow receive oral mercaptopurine daily beginning on
day 29. Patients with M2 bone marrow on day 29 receive oral dexamethasone twice daily on
days 29-42, vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36, and
asparaginase IM on days 29, 32, 36, and 39. Patients with M3 bone marrow on day 29 or M2 or
M3 bone marrow on day 43 are taken off study. Consolidation: Patients receive methotrexate
IV over 4 hours once a week during weeks 7, 10, 13, 24, 27, and 30, oral leucovorin calcium
every 6 hours for 5 doses beginning 42 hours after the start of methotrexate infusion,
methotrexate IT during weeks 5, 9, 12, 16, 20, 21, and 29, asparaginase IM 3 times weekly
during weeks 16 and 17, and oral mercaptopurine daily during weeks 5-14 and from week 24
until the end of consolidation. Patients receive oral dexamethasone twice daily during weeks
8, 16-18, and 28, vincristine IV on day 1 during weeks 8, 9, 16, 17, 18, 28, and 29,
daunorubicin IV on day 1 during weeks 16, 17, and 18, cyclophosphamide IV over 30 minutes on
day 1 during week 20, cytarabine IV or subcutaneously on days 2-5 during weeks 20 and 21,
and oral thioguanine daily during weeks 20 and 21. Intensive continuation: Patients receive
oral methotrexate every 6 hours for 24 hours during weeks 1, 3, 5, and 7, oral
mercaptopurine daily, and oral leucovorin calcium every 12 hours for 1 day beginning 48
hours after the start of oral methotrexate. Patients also receive methotrexate IT during
week 8, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days
beginning with vincristine. Treatment repeats every 8 weeks for 6 courses. Another
continuation: Patients receive oral methotrexate once weekly except during the week of
methotrexate IT administration, oral mercaptopurine daily, methotrexate IT every 8 weeks,
vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days
beginning with vincristine. Treatment continues for up to 130 weeks in the absence of
disease progression or unacceptable toxicity. Patients are followed every 6 months for 4
years and then annually until death.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically newly diagnosed early B-cell or B-precursor or
B-progenitor acute lymphocytic leukemia Prior registration on POG-9400, stratum 6 for
induction therapy Average prognosis (neither very good nor very poor)

PATIENT CHARACTERISTICS: Age: Children Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No prior therapy other than on POG-9400

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Naomi J. Winick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066768

NCT ID:

NCT00003671

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Leukemia
  • untreated childhood acute lymphoblastic leukemia
  • B-cell childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
Hurley Medical CenterFlint, Michigan  48503
Oklahoma Memorial HospitalOklahoma City, Oklahoma  73126-0307
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
Vermont Cancer CenterBurlington, Vermont  05401-3498
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Baptist Hospital of MiamiMiami, Florida  33176-2197
Tulane University School of MedicineNew Orleans, Louisiana  70112
University of Texas Medical BranchGalveston, Texas  77555-1329
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Madigan Army Medical CenterTacoma, Washington  98431-5048
Sutter Cancer CenterSacramento, California  95816
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Eastern Maine Medical CenterBangor, Maine  04401
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Nemours Children's ClinicJacksonville, Florida  32207
St. Mary's HospitalWest Palm Beach, Florida  33407
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
University of Missouri-Columbia Hospital and ClinicsColumbia, Missouri  65212
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Via Christi Regional Medical Center-Saint Francis CampusWichita, Kansas  67214
Children's Memorial Hospital, ChicagoChicago, Illinois  60614
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Scott and White ClinicTemple, Texas  76508
James H. Quillen College of MedicineJohnson City, Tennessee  37614-0622
Walt Disney Memorial Cancer InstituteOrlando, Florida  32803
University of New Mexico School of MedicineAlbuquerque, New Mexico  87131
St. John's Hospital and Medical CenterDetroit, Michigan  48236
Christ HospitalOak Lawn, Illinois  60453
Carilion Roanoke Memorial HospitalRoanoke, Virginia  24029
West Virginia University Medical School, Charleston DivisionCharleston, West Virginia  25304