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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| 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 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children |
| Estimated Enrollment: | 45 |
| Study Start Date: | December 1998 |
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 |
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| Belgium | |
| Algemeen Ziekenhuis Middelheim | |
| Antwerp, Belgium, 2020 | |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | |
| Brussels (Bruxelles), Belgium, 1090 | |
| Hopital Universitaire Des Enfants Reine Fabiola | |
| Brussels (Bruxelles), Belgium, 1020 | |
| Universitair Ziekenhuis Gent | |
| Ghent (Gent), Belgium, B-9000 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Centre Hospitalier Regional de la Citadelle | |
| Liege (Luik), Belgium, 4000 | |
| Clinique de l'Esperance | |
| Montegnee, Belgium, 4420 | |
| France | |
| Centre Hospitalier Regional et Universitaire d'Angers | |
| Angers, France, 49033 | |
| CHR de Besancon - Hopital Saint-Jacques | |
| Besancon, France, 25030 | |
| CHU de Caen | |
| Caen, France, 14033 | |
| CHR de Grenoble - La Tronche | |
| Grenoble, France, 38043 | |
| Centre Hospitalier Regional de Lille | |
| Lille, France, 59037 | |
| Hopital Debrousse | |
| Lyon, France, 69322 | |
| Hopital Arnaud de Villeneuve | |
| Montpellier, France, 34295 | |
| CHR Hotel Dieu | |
| Nantes, France, 44093 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Institut Curie - Section Medicale | |
| Paris, France, 75248 | |
| Hopital Robert Debre | |
| Paris, France, 75019 | |
| Hopital Jean Bernard | |
| Poitiers, France, 86021 | |
| Hopital Americain | |
| Reims, France, 51092 | |
| Hopital Universitaire Hautepierre | |
| Strasbourg, France, 67098 | |
| Hopital des Enfants (Purpan Enfants) | |
| Toulouse, France, 31026 | |
| Portugal | |
| Hospital Escolar San Joao | |
| Porto, Portugal, 4200 | |
| Study Chair: | Antoine Thyss, MD | Centre Antoine Lacassagne |
More Information
| ClinicalTrials.gov Identifier: | NCT00003729 History of Changes |
| Other Study ID Numbers: | CDR0000066841, EORTC-58953 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
recurrent childhood acute lymphoblastic leukemia L1 childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia |
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Fludarabine monophosphate Vidarabine Fludarabine |
Idarubicin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic |
