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ALinC 17: Continuous Intensification for Very High Risk Acute Lymphocytic Leukemia (A.L.L.): A Pediatric Oncology Group Pilot Study


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

Thank you

Trial Information

ALinC 17: Continuous Intensification for Very High Risk Acute Lymphocytic Leukemia (A.L.L.): A Pediatric Oncology Group Pilot Study


OBJECTIVES: I. Determine the feasibility of administering a new combination of agents during
postinduction consolidation therapy in children with very high risk acute lymphocytic
leukemia (VHR-ALL). II. Assess the tolerance of patients in remission of VHR-ALL for
postconsolidation therapy with continuous intensification.

OUTLINE: Patients receive induction therapy on weeks 1-4. This consists of oral prednisone
three times a day on days 1-28; vincristine IV on days 1, 8, 15, and 22; daunorubicin IV on
days 8, 15, and 22; and asparaginase IM on days 2, 5, 8, 12, 15, and 19. Patients also
receive methotrexate intrathecally (IT) on days 1 and 8. Patients with CNS 2 and 3 disease
also receive methotrexate IT on days 15 and 22. Patients who achieve M2 bone marrow on day
29 receive oral prednisone three times a day 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. If
bone marrow is M3 on day 29 or M2 or M3 on day 43, then patient is off study. Patients
proceed to consolidation therapy on weeks 5-25. This consists of high dose methotrexate IV
over 24 hours on weeks 6, 8, 16, and 18, followed by leucovorin calcium IV or orally every 6
hours for 5 doses; oral mercaptopurine on weeks 6-9 and 16-19; cytarabine IV over 6 hours
followed by idarubicin IV over 15 minutes for 4 days; and filgrastim (G-CSF) subcutaneously
(SQ) beginning on day 5 and continuing for about 10-14 days on weeks 10 and 20. Patients
receive etoposide IV over 1 hour followed by cyclophosphamide IV over 10 minutes for 5 days
and G-CSF SQ beginning on day 6 for 10-14 days on weeks 13 and 23. Methotrexate IT is
administered on weeks 6, 8, 13, 16, 18, and 23. Patients then proceed to continuous
intensification therapy during weeks 26-61. Patients receive vincristine IV, daunorubicin
IV, and methotrexate IT on day 1, and oral dexamethasone twice a day on days 1-7 on weeks
26, 32, 38, 44, 50, and 56. Patients also receive high dose cytarabine IV over 1 hour, every
12 hours, for 4 doses, followed by asparaginase IM 3 hours after the last dose of
cytarabine, on weeks 27, 33, 39, 45, 51, and 57. Oral mercaptopurine and methotrexate IM are
administered on day 1 during weeks 29, 31, 35, 37, 41, 43, 47, 49, 53, 55, 59, and 61.
Patients receive etoposide IV over 1-2 hours followed by cyclophosphamide IV during weeks
30, 36, 42, 48, 54, and 60. Patients then proceed to continuation therapy during weeks
62-126. Vincristine IV and cyclophosphamide IV are administered on weeks 62-65, 70-73,
78-81, 86-89, 94-97, 102-105, 110-113, and 118-121. Patients also receive oral dexamethasone
twice a day for 7 days on weeks 62, 70, 78, 86, 94, 102, 110, and 118, and cytarabine IV on
weeks 63, 65, 71, 73, 79, 81, 87, 89, 95, 97, 103, 105, 111, 113, 119, and 121. Oral
mercaptopurine is administered daily during weeks 66-69, 74-77, 82-85, 90-93, 98-101,
106-109, 114-117, and 122-125 and methotrexate IM on weeks 66-69, 74-77, 82-85, 90-93,
98-101, 106-109, 114-117, and 122-125. Methotrexate IT is administered during weeks 62, 70,
78, 86, 94, 102, 110, and 118. Patients who are CNS 3 at diagnosis receive whole brain
irradiation beginning at week 62 along with the first course of continuation therapy. These
patients do not receive any methotrexate IT after week 62. Patients are followed monthly for
1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year,
then annually thereafter.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Newly diagnosed B-cell precursor acute lymphocytic leukemia No L3
morphology Very poor prognosis CNS 3 (blasts and WBC greater than 5 microliters) OR Must
meet all of the following criteria: No simultaneous trisomy 4 and 10 DNA index no greater
than 1.16 (if FISH 4 and 10 unsatisfactory) No TEL-AML1 [t(12;21)] Meets at least 1 of the
following: Has MLL (11q23) and/or BCR-ABL [t(9;22)] WBC greater than 100,000/mm3 Age over
12 (boys) or 16 (girls) OR Boys Girls WBC 8 12 greater than 80,000/mm3 9 13 greater than
60,000/mm3 10 14 greater than 40,000/mm3 11 15 greater than 20,000/mm3 Concurrent
registration on stratum 6 of POG-9400 before 11/15/1999 OR Concurrent registration on
stratum 4 of POG-9900 after 11/15/1999 Concurrent registration on POG-9201, POG-9705, or
POG-9806 unless ineligible

PATIENT CHARACTERISTICS: Age: Children Performance status: Not specified Life expectancy:
Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not
specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William P. Bowman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cook Children's Medical Center - Fort Worth

Authority:

United States: Federal Government

Study ID:

CDR0000066915

NCT ID:

NCT00003783

Start Date:

March 1999

Completion Date:

Related Keywords:

  • Leukemia
  • untreated childhood acute lymphoblastic leukemia
  • L1 childhood acute lymphoblastic leukemia
  • L2 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
Via Christi Regional Medical CenterWichita, Kansas  67214
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
Hope Children's HospitalOak Lawn, Illinois  60453
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
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
Carilion Roanoke Community HospitalRoanoke, Virginia  24013
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
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
West Virginia University Medical School, Charleston DivisionCharleston, West Virginia  25304