Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003671
Recruitment Status : Completed
First Posted : September 13, 2004
Last Update Posted : July 25, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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
Leukemia Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: thioguanine Drug: vincristine sulfate 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
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 : December 1998
Actual Primary Completion Date : November 2002
Actual Study Completion Date : February 2009

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

Primary Outcome Measures :
  1. Event-free survival [ Time Frame: 7 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003671

  Show 57 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Naomi J. Winick, MD Simmons Cancer Center

Responsible Party: Children's Oncology Group Identifier: NCT00003671     History of Changes
Other Study ID Numbers: 9705
POG-9705 ( Other Identifier: Pediatric Oncology Group )
CDR0000066768 ( Other Identifier: Clinical )
First Posted: September 13, 2004    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: July 2014

Keywords provided by Children's Oncology Group:
untreated childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal