Clincosm LogoSign in Get a demo

Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00003671
Collaborator
National Cancer Institute (NCI) (NIH)
59
Enrollment
57
Locations
1
Arm
122.1
Duration (Months)
1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphocytic leukemia.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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 for ten years.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Protocol for Patients With Newly Diagnosed Better Risk Acute Lymphoblastic Leukemia (ALL): A POG Pilot Study
Study Start Date :
Dec 1, 1998
Actual Primary Completion Date :
Nov 1, 2002
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chemotherapy Treatment

See detailed description.

Drug: asparaginase
Other Names:
  • E. coli
  • Elspar
  • NSC #109229

    • Drug: cyclophosphamide
    Other Names:
  • CTX
  • Cytoxan
  • NSC #026271
  • IND #7089

    • Drug: cytarabine
    Other Names:
  • cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #063878

    • Drug: daunorubicin hydrochloride
    Other Names:
  • daunomycin
  • DNR
  • Cerubidine
  • NSC #82151

    • Drug: dexamethasone
    Other Names:
  • Decadron
  • NSC #034521

    • Drug: leucovorin calcium
    Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590

    • Drug: mercaptopurine
    Other Names:
  • 6-MP
  • Purinethol
  • NSC #000755

    • Drug: methotrexate
    Other Names:
  • MTX
  • amethopterin
  • NSC #000740
  • IND #4291

    • Drug: thioguanine
    Other Names:
  • 6-thioguanine
  • 6-TG
  • NSC #752

    • Drug: vincristine sulfate
    Other Names:
  • VCR
  • Oncovin
  • NSC #067574
  • IND #7161

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Event-free survival [7 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Cancer Center Tucson Arizona United States 85724
    2 Lucile Packard Children's Hospital at Stanford Palo Alto California United States 94304
    3 Sutter Cancer Center Sacramento California United States 95816
    4 Kaiser Permanente-Southern California Permanente Medical Group San Diego California United States 92120
    5 Naval Medical Center - San Diego San Diego California United States 92134-3202
    6 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051-5386
    7 Nemours Children's Clinic Jacksonville Florida United States 32207
    8 Sylvester Cancer Center, University of Miami Miami Florida United States 33136
    9 Baptist Hospital of Miami Miami Florida United States 33176-2197
    10 Walt Disney Memorial Cancer Institute Orlando Florida United States 32803
    11 St. Mary's Hospital West Palm Beach Florida United States 33407
    12 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    13 Tripler Army Medical Center Honolulu Hawaii United States 96859-5000
    14 Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612
    15 Children's Memorial Hospital, Chicago Chicago Illinois United States 60614
    16 Christ Hospital Oak Lawn Illinois United States 60453
    17 Saint Jude Midwest Affiliate Peoria Illinois United States 61602
    18 Via Christi Regional Medical Center-Saint Francis Campus Wichita Kansas United States 67214
    19 Tulane University School of Medicine New Orleans Louisiana United States 70112
    20 Eastern Maine Medical Center Bangor Maine United States 04401
    21 Maine Children's Cancer Program Portland Maine United States 04101
    22 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    23 St. John's Hospital and Medical Center Detroit Michigan United States 48236
    24 Hurley Medical Center Flint Michigan United States 48503
    25 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    26 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
    27 University of Missouri-Columbia Hospital and Clinics Columbia Missouri United States 65212
    28 Washington University School of Medicine Saint Louis Missouri United States 63110
    29 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756
    30 University of New Mexico School of Medicine Albuquerque New Mexico United States 87131
    31 State University of New York Health Sciences Center - Stony Brook Stony Brook New York United States 11790-9832
    32 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    33 Oklahoma Memorial Hospital Oklahoma City Oklahoma United States 73126-0307
    34 Natalie Warren Bryant Cancer Center Tulsa Oklahoma United States 74136
    35 James H. Quillen College of Medicine Johnson City Tennessee United States 37614-0622
    36 Medical City Dallas Hospital Dallas Texas United States 75230
    37 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    38 Cook Children's Medical Center - Fort Worth Fort Worth Texas United States 76104
    39 University of Texas Medical Branch Galveston Texas United States 77555-1329
    40 Baylor College of Medicine Houston Texas United States 77030
    41 San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base Texas United States 78236-5300
    42 Scott and White Clinic Temple Texas United States 76508
    43 Vermont Cancer Center Burlington Vermont United States 05401-3498
    44 Inova Fairfax Hospital Falls Church Virginia United States 22046
    45 Carilion Roanoke Memorial Hospital Roanoke Virginia United States 24029
    46 Madigan Army Medical Center Tacoma Washington United States 98431-5000
    47 West Virginia University Medical School, Charleston Division Charleston West Virginia United States 25304
    48 West Virginia University Hospitals Morgantown West Virginia United States 26506-9162
    49 St. Vincent Hospital Green Bay Wisconsin United States 54307-3508
    50 Midwest Children's Cancer Center Milwaukee Wisconsin United States 53226
    51 Alberta Children's Hospital Calgary Alberta Canada T2T 5C7
    52 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
    53 Montreal Children's Hospital Montreal Quebec Canada H3H 1P3
    54 Centre Hospitalier de L'Universite Laval Sainte Foy Quebec Canada GIV 4G2
    55 Academisch Ziekenhuis Groningen Groningen Netherlands 9713 EZ
    56 San Jorge Childrens Hospital Santurce Puerto Rico 00912
    57 Clinique de Pediatrie Geneva Switzerland 1211

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Naomi J. Winick, MD, Simmons Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00003671
    Other Study ID Numbers:
    • 9705
    • POG-9705
    • CDR0000066768
    First Posted:
    Sep 13, 2004
    Last Update Posted:
    Jul 25, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by Children's Oncology Group
    untreated childhood acute lymphoblastic leukemia
    B-cell childhood acute lymphoblastic leukemia
    Additional relevant MeSH terms:
    Leukemia
    Leucovorin
    Cytarabine
    Dexamethasone
    Cyclophosphamide
    Methotrexate
    Vincristine
    Daunorubicin
    Asparaginase
    Mercaptopurine
    Thioguanine
    Levoleucovorin

    Study Results

    No Results Posted as of Jul 25, 2014