Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia

July 24, 2014 updated by: Children's Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemotherapy Treatment
See detailed description.
Drug: cyclophosphamide
Other Names:
  • Cytoxan
  • CTX
  • NSC #026271
  • IND #7089
Drug: leucovorin calcium
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: asparaginase
Other Names:
  • E. coli
  • Elspar
  • NSC #109229
Drug: cytarabine
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #063878
Drug: daunorubicin hydrochloride
Other Names:
  • Cerubidine
  • daunomycin
  • DNR
  • NSC #82151
Drug: dexamethasone
Other Names:
  • Decadron
  • NSC #034521
Drug: methotrexate
Other Names:
  • amethopterin
  • MTX
  • NSC #000740
  • IND #4291
Drug: vincristine sulfate
Other Names:
  • VCR
  • Oncovin
  • NSC #067574
  • IND #7161
Drug: mercaptopurine
Other Names:
  • 6-MP
  • Purinethol
  • NSC #000755
Drug: thioguanine
Other Names:
  • 6-thioguanine
  • 6-TG
  • NSC #752

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event-free survival
Time Frame: 7 years
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1998

Primary Completion (Actual)

November 1, 2002

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

September 10, 2004

First Posted (Estimate)

September 13, 2004

Study Record Updates

Last Update Posted (Estimate)

July 25, 2014

Last Update Submitted That Met QC Criteria

July 24, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9705
  • POG-9705 (Other Identifier: Pediatric Oncology Group)
  • CDR0000066768 (Other Identifier: Clinical Trials.gov)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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