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INDUCTION INTENSIFICATION AND ALLOGENEIC BONE MARROW TRANSPLANT IN INFANT ALL: A PEDIATRIC ONCOLOGY GROUP PILOT STUDY Induction Intensification and Allogeneic Bone Marrow Transplant in Infant ALL: A Children's Oncology Group Pilot Study


Phase 2
N/A
1 Year
Not Enrolling
Both
Leukemia

Thank you

Trial Information

INDUCTION INTENSIFICATION AND ALLOGENEIC BONE MARROW TRANSPLANT IN INFANT ALL: A PEDIATRIC ONCOLOGY GROUP PILOT STUDY Induction Intensification and Allogeneic Bone Marrow Transplant in Infant ALL: A Children's Oncology Group Pilot Study


OBJECTIVES:

Primary

- Assess the feasibility of intensification with two courses of high-dose methotrexate
followed by one course of cyclophosphamide/etoposide during induction and later as
consolidation in infants with newly diagnosed acute lymphoblastic leukemia.

- Determine event-free survival after shortened, intensive therapy in these patients.

- Compare event-free survival rates of infants receiving this regimen whose leukemic
blasts have or do not have translocations involving the 11q23 gene MLL.

Secondary

- Correlate the presence of minimal residual disease at completion of induction,
beginning of continuation, and at completion of therapy with patient outcome.

- Investigate the clinical prognostic features that may be associated with outcome in
infants, such as bone marrow blast content at day 8, white blood cell count, and age.

- Correlate biologic characteristics of the leukemia cells at diagnosis (protocol
POG-9900) with outcome in patients treated with this regimen.

- Characterize patterns of gene expression associated with host and disease
characteristics and treatment response in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to participating
center and presence of CNS disease (yes vs no).

Patients receive induction chemotherapy comprising vincristine IV on days 1, 8, and 15; oral
prednisone three times a day on days 1-21; daunorubicin IV over 30 minutes on days 1-2;
cyclophosphamide IV over 30 minutes every 12 hours on days 3-4; and asparaginase
intramuscularly (IM) on days 4, 6, 8, 10, 12, 15, 17, and 19. Patients also receive triple
intrathecal therapy comprising methotrexate, hydrocortisone, and cytarabine on days 1, 8,
and 15 and filgrastim (G-CSF) subcutaneously (SC) or IV beginning on day 5 and continuing
until day 20, regardless of blood counts.

Patients receive induction intensification chemotherapy comprising high-dose methotrexate IV
over 24 hours; triple intrathecal therapy as per induction therapy on days 22 and 29; and
leucovorin calcium IV every 6 hours for 2 doses beginning 42 hours after start of high-dose
methotrexate and then orally every 6 hours for 3 doses. Patients also receive etoposide IV
over 2 hours and cyclophosphamide IV over 30 minutes on days 36-40. Patients receive G-CSF
SC or IV beginning on day 41 and continuing until blood counts recover.

Patients achieving morphologic remission and recovery of blood counts while off G-CSF for 48
hours receive reinduction chemotherapy comprising the same regimen as in induction therapy
with the exception of asparaginase IM beginning on day 1 (week 8) and continuing every
Monday, Wednesday, and Friday for a total of 8 doses and triple intrathecal therapy on days
1 and 15 only (weeks 8 and 10). Patients receive G-CSF SC or IV beginning on day 5 and
continuing until blood counts recover.

After blood count recovery, patients receive consolidation chemotherapy comprising triple
intrathecal therapy as per induction therapy on day 1 (week 11); high-dose methotrexate IV
over 24 hours on weeks 8 and 12; and leucovorin calcium IV every 6 hours for 2 doses
beginning 42 hours after start of high-dose methotrexate and then orally every 6 hours for 3
doses. Patients also receive etoposide IV over 2 hours followed by cyclophosphamide IV over
30 minutes on days 15-19 (week 13). Patients receive G-CSF SC or IV beginning on day 20 and
continuing until blood counts recover. On days 29-31 (week 15), patients receive high-dose
cytarabine IV over 3 hours every 12 hours for 4 doses and asparaginase IM 6 hours after
completion of high-dose cytarabine. Patients receive G-CSF beginning 24 hours after
completion of asparaginase and continuing until blood counts recover.

Patients achieving morphologic remission and blood count recovery while off G-CSF for 48
hours receive continuation therapy comprising vincristine IV on day 1; oral prednisone three
times a day on days 1-5; and triple intrathecal therapy on day 1 (weeks 18 and 22). Patients
also receive methotrexate IM once a week and oral mercaptopurine daily on weeks 19-21, 23,
and 24. On week 25, patients receive etoposide IV over 2 hours daily followed by
cyclophosphamide IV over 30 minutes daily on days 1-5 and G-CSF SC or IV beginning on day 6
and continuing until blood counts recover. Patients receive an additional course of
continuation therapy on weeks 28-35. On weeks 38-48, patients receive another identical
course of continuation therapy with the exclusion of the etoposide and cyclophosphamide
combination regimen.

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, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 58-104 patients will be accrued for this study within 2.1
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia

- No infants less than 36 weeks' gestation

- CNS or testicular disease permitted

- No B-cell ALL or acute myeloid leukemia

- Previously untreated except for the following:

- Steroid treatment within 48 hours of diagnosis allowed with physical examination
and differential CBC immediately prior to beginning steroids

- Concurrent registration on protocol POG-9900 (ALL classification study) required

- Patients registered on POG-9407 are eligible for the pharmacokinetic part of the
study

PATIENT CHARACTERISTICS:

Age:

- Under 1 at diagnosis

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No uncontrolled infection

- Adequate major organ function

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- See Disease Characteristics

- No concurrent chronic steroid treatment

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of intensification

Safety Issue:

No

Principal Investigator

Zoann E. Dreyer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Texas Children's Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064693

NCT ID:

NCT00002756

Start Date:

June 1996

Completion Date:

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Hurley Medical CenterFlint, Michigan  48503
Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
University of Texas Medical BranchGalveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Sutter Cancer CenterSacramento, California  95816
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Nemours Children's ClinicJacksonville, Florida  32207
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Schneider Children's HospitalNew Hyde Park, New York  11042
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Sunrise Hospital and Medical CenterLas Vegas, Nevada  89109-2306
Maimonides Medical CenterBrooklyn, New York  11219
Children's Hospital Medical Center of AkronAkron, Ohio  44308
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Covenant Children's HospitalLubbock, Texas  79410
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Winthrop University HospitalMineola, New York  11501
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Children's Hospital and Research Center - OaklandOakland, California  94609-1809
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Children's Hospital and Health Center - San DiegoSan Diego, California  92123-4282
Santa Barbara Cottage Children's HospitalSanta Barbara, California  93105
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
Broward General Medical Center Cancer CenterFt. Lauderdale, Florida  33316
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Sacred Heart Cancer Center at Sacred Heart HospitalPensacola, Florida  32504
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
St. Luke's Mountain States Tumor Institute - BoiseBoise, Idaho  83712-6297
Advocate Christ Medical CenterOak Lawn, Illinois  60453
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Blank Children's HospitalDes Moines, Iowa  50309
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
CancerCare of Maine at Eastern Maine Medial CenterBangor, Maine  04401
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Floating Hospital for Children at Tufts - New England Medical CenterBoston, Massachusetts  02111
C.S. Mott Children's Hospital at University of MichiganAnn Arbor, Michigan  48109-0238
Spectrum Health Cancer Care - Butterworth CampusGrand Rapids, Michigan  49503-2560
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
University of Minnesota Medical Center - FairviewMinneapolis, Minnesota  55455
Children's Hospitals and Clinics of MinneapolisMinneapolis, Minnesota  55404
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Mount Sinai Medical CenterNew York, New York  10029
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
Tod Children's Hospital - Forum HealthYoungstown, Ohio  44501
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
Texas Tech University Health Sciences Center School of Medicine - AmarilloAmarillo, Texas  79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Naval Medical Center - PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
Carilion Cancer Center of Western VirginiaRoanoke, Virginia  24029
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
Edwards Comprehensive Cancer Center at Cabell Huntington HospitalHuntington, West Virginia  25701
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508