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Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
This study has been completed.
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00016302
  Purpose

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: This phase II trial is studying several different combination chemotherapy regimens to see how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia.


Condition Intervention Phase
Leukemia
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: nelarabine
Drug: pegaspargase
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Procedure: radiation therapy
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Cytarabine Cytarabine hydrochloride Mercaptopurine 6-Mercaptopurine L-Asparaginase Daunorubicin hydrochloride Daunorubicin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Prednisone Vincristine sulfate Vincristine Calcium gluconate Thioguanine Pegaspargase Nelarabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: The Use Of Modified BFM +/- Compound 506U78 (NSC# 686673) In an Intensive Chemotherapy Regimen For The Treatment Of T-Cell Leukemia

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Feasibility [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics and intracellular pharmacology [ Designated as safety issue: No ]

Study Start Date: April 2001
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed T-cell acute lymphoblastic leukemia with greater than 25% bone marrow blasts (M3)

    • High-risk disease, defined as meeting at least 1 of the following criteria:

      • WBC at least 50,000/mm^3
      • Age 10 years or over
  • Patients with WBC at least 25,000/mm^3 AND at least 50% peripheral blood blasts are eligible provided bone marrow aspiration was contraindicated (e.g., patient was not eligible for anesthesia or sedation due to respiratory distress secondary to anterior mediastinal mass)
  • Concurrent registration to POG 9900 within the past 8 days required

PATIENT CHARACTERISTICS:

Age:

  • 1 to 21

Performance status:

  • Karnofsky 50-100% (over 10 years of age) OR
  • Lansky 50-100% (10 years of age and under)

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGPT less than 5 times normal

Renal:

  • Creatinine normal OR
  • Creatinine clearance or glomerular filtration rate at least 60 mL/min

Other:

  • No pre-existing neuropathy of grade 2 or worse unless due to leukemic infiltration
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy

Chemotherapy:

  • No more than 72 hours since prior intrathecal cytarabine
  • No other prior chemotherapy

Endocrine therapy:

  • Prior steroids allowed
  • No chronic steroid treatment for another disease

Radiotherapy:

  • Prior emergency radiotherapy to mediastinum for severe respiratory distress allowed

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016302

  Show 231 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Kimberly Dunsmore, MD Children's Medical Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Dunsmore K, Devidas M, Borowitz MJ, et al.: Nelarabine can be safely incorporated into an intensive, multiagent chemotherapy regimen for the treatment of T-cell acute lymphocytic leukemia (ALL) in children: a report of the Children's Oncology Group (COG) AALL00P2 protocol for T-cell leukemia. [Abstract] Blood 108 (11): A-1864, 2006.

Study ID Numbers: CDR0000068620, COG-AALL00P2
Study First Received: May 6, 2001
Last Updated: August 23, 2008
ClinicalTrials.gov Identifier: NCT00016302  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated childhood acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia

Study placed in the following topic categories:
Dexamethasone
Asparaginase
Prednisone
Daunorubicin
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Thioguanine
Vincristine
Leucovorin
6-Mercaptopurine
Cyclophosphamide
Doxorubicin
Folic Acid
Calcium, Dietary
Pegaspargase
Leukemia
Lymphatic Diseases
Leukemia, T-Cell
Methotrexate
Lymphoproliferative Disorders
Lymphoma
Cytarabine
Dexamethasone acetate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Antibiotics, Antineoplastic
Hormones
Vitamins
Therapeutic Uses
Abortifacient Agents
Micronutrients
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Vitamin B Complex
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Growth Substances
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009