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Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003729
  Purpose

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

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


Condition Intervention Phase
Leukemia
Drug: cytarabine
Drug: fludarabine phosphate
Drug: idarubicin
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Childhood   

ChemIDplus related topics:   Cytarabine    Cytarabine hydrochloride    Idarubicin    Idarubicin hydrochloride    Fludarabine    Fludarabine monophosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children

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

Estimated Enrollment:   45
Study Start Date:   December 1998

Detailed Description:

OBJECTIVES: I. Evaluate the complete response rate to combination fludarabine, idarubicin, and cytarabine in children with relapsed or refractory acute lymphocytic leukemia. II. Evaluate the safety and tolerance of this treatment in these patients. III. Evaluate the time to progression, disease free survival, and overall survival of these patients.

OUTLINE: This is an open label, multicenter study. Patients receive idarubicin IV over 1 hour on days 1-3. Fludarabine IV is administered over 30 minutes on days 1-5. Cytarabine IV is administered over 4 hours on days 1-5. If partial response is obtained, patients receive a second course of treatment. Patients receive a consolidation course in the absence of disease progression and unacceptable toxicity. Idarubicin IV is administered over 1 hour on days 1 and 2. Fludarabine IV is administered over 30 minutes, followed by cytarabine IV over 4 hours on days 1-5. Patients are followed every 3 months for 2 years or until death.

PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 27 months.

  Eligibility
Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Cytologically diagnosed relapsed or refractory acute lymphocytic leukemia previously treated with front line therapy FAB L1 or L2 Bone marrow relapse either isolated or associated with CNS or testicular relapse Bone marrow blast cells greater than 10% No isolated CNS relapse

PATIENT CHARACTERISTICS: Age: Under 18 Performance status: WHO 0-2 Play-performance scale at least 60% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.5 times normal Renal: Creatinine less than 2.5 times normal Cardiovascular: No symptoms of cardiac failure No decline of ejection fraction by more than 20% of the lower limit of normal Shortening fraction at least 25% Other: No psychological, familial, sociological or geographical condition that would hamper compliance No uncontrolled infection

PRIOR CONCURRENT THERAPY: At least 6 months since prior autologous bone marrow transplantation No prior allogeneic bone marrow transplantation No concurrent treatment with other experimental drug

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003729

Locations
Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel    
      Brussels (Bruxelles), Belgium, 1090
Algemeen Ziekenhuis Middelheim    
      Antwerp, Belgium, 2020
Centre Hospitalier Regional de la Citadelle    
      Liege (Luik), Belgium, 4000
Clinique de l'Esperance    
      Montegnee, Belgium, 4420
Hopital Universitaire Des Enfants Reine Fabiola    
      Brussels (Bruxelles), Belgium, 1020
U.Z. Gasthuisberg    
      Leuven, Belgium, B-3000
Universitair Ziekenhuis Gent    
      Ghent (Gent), Belgium, B-9000
France
Centre Antoine Lacassagne    
      Nice, France, 06189
Centre Hospitalier Regional de Lille    
      Lille, France, 59037
Centre Hospitalier Regional et Universitaire d'Angers    
      Angers, France, 49033
CHR de Besancon - Hopital Saint-Jacques    
      Besancon, France, 25030
CHR de Grenoble - La Tronche    
      Grenoble, France, 38043
CHR Hotel Dieu    
      Nantes, France, 44093
CHU de Caen    
      Caen, France, 14033
Hopital Americain    
      Reims, France, 51092
Hopital Arnaud de Villeneuve    
      Montpellier, France, 34295
Hopital Debrousse    
      Lyon, France, 69322
Hopital des Enfants (Purpan Enfants)    
      Toulouse, France, 31026
Hopital Jean Bernard    
      Poitiers, France, 86021
Hopital Robert Debre    
      Paris, France, 75019
Hopital Universitaire Hautepierre    
      Strasbourg, France, 67098
Institut Curie - Section Medicale    
      Paris, France, 75248
Portugal
Hospital Escolar San Joao    
      Porto, Portugal, 4200

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Antoine Thyss, MD     Centre Antoine Lacassagne    
  More Information


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

Study ID Numbers:   CDR0000066841, EORTC-58953
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003729
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia  
L1 childhood acute lymphoblastic leukemia  
L2 childhood acute lymphoblastic leukemia  

Study placed in the following topic categories:
Lymphatic Diseases
Leukemia
Idarubicin
Leukemia, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Fludarabine
Fludarabine monophosphate
Lymphoproliferative Disorders
Lymphoma
Cytarabine
Recurrence

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses

ClinicalTrials.gov processed this record on October 15, 2008




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