Comparison of Different Combination Chemotherapy Regimens in Treating Infants With Acute Lymphoblastic Leukemia - Full Text View

Sponsor:	Dutch Childhood Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00015873

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. It is not yet known which combination chemotherapy regimen is most effective for treating infants with acute lymphoblastic leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed acute lymphoblastic leukemia.

Condition	Intervention	Phase
Leukemia	Drug: asparaginase Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisolone Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation	Phase III

Study Type:	Interventional
Study Design:	Treatment
Official Title:	International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Leukemia, Childhood

Drug Information available for: Dexamethasone Cyclophosphamide Prednisolone 6-Mercaptopurine Prednisolone acetate Prednisone Depo-medrol Busulfan Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Etoposide Citrovorum factor Dexamethasone acetate Cyclosporine Doxiproct plus Medrol veriderm Cyclosporin Methylprednisolone Etoposide phosphate Prednisolone sodium phosphate Cytarabine Thioguanine Leucovorin Calcium Prednisolone Sodium Succinate Dexamethasone Sodium Phosphate Vincristine sulfate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate Folinic acid calcium salt pentahydrate Mercaptopurine 6-Methylprednisolone L-Asparaginase

U.S. FDA Resources

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

Primary Outcome Measures:

Event-free survival at 3-4 years after diagnosis [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	May 1999

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Eligibility

Ages Eligible for Study:	up to 1 Year
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of acute lymphoblastic leukemia (ALL)
- Newly diagnosed
- Morphological verification by cytochemistry and immunophenotyping
CNS or testicular leukemia at diagnosis allowed
Trisomy 21 allowed

PATIENT CHARACTERISTICS:

Age:

365 days or less

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for leukemia

Endocrine therapy:

At least 4 weeks since prior systemic corticosteroids
Prior inhaled steroids allowed

Radiotherapy:

No prior radiotherapy for leukemia

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015873

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Locations

United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Austria
St. Anna Children's Hospital
Vienna, Austria, A-1090
Belgium
Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Belgium, 1020
Czech Republic
University Hospital Motol
Prague, Czech Republic, 150 06
France
Hopital Saint-Louis
Paris, France, 75475
Germany
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
University Medical Center Hamburg - Eppendorf
Hamburg, Germany, D-20246
Ireland
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
Italy
Nuovo Ospedale San Gerardo at University of Milano-Bicocca
Monza, Italy, 20052
Ospedale San Gerardo
Monza, Italy, 20052
Netherlands
Erasmus MC - Sophia Children's Hospital
Rotterdam, Netherlands, 3015 GJ
Sweden
Ostra Sjukhuset
Gothenburg, Sweden, 41685
United Kingdom, England
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom, M27 4HA
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom, WC1N 3JH
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal London Hospital
London, England, United Kingdom, E1 1BB
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sir James Spence Institute of Child Health
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Southampton University Hospital NHS Trust
Southampton, England, United Kingdom, SO16 6YD
United Kingdom, Northern Ireland
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
United Kingdom, Scotland
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
United Kingdom, Wales
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW

Sponsors and Collaborators

Dutch Childhood Oncology Group

Investigators

Study Chair:

Rob Pieters, MD, MSC, PhD

Erasmus MC - Sophia Children's Hospital

More Information

Additional Information:

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

Publications:

Lönnerholm G, Valsecchi MG, De Lorenzo P, Schrappe M, Hovi L, Campbell M, Mann G, Janka-Schaub G, Li CK, Stary J, Hann I, Pieters R; Interfant-99 study group. Pharmacokinetics of high-dose methotrexate in infants treated for acute lymphoblastic leukemia. Pediatr Blood Cancer. 2009 May;52(5):596-601.

van der Linden MH, Valsecchi MG, De Lorenzo P, Möricke A, Janka G, Leblanc TM, Felice M, Biondi A, Campbell M, Hann I, Rubnitz JE, Stary J, Szczepanski T, Vora A, Ferster A, Hovi L, Silverman LB, Pieters R. Outcome of congenital acute lymphoblastic leukemia treated on the Interfant-99 protocol. Blood. 2009 Oct 29;114(18):3764-8. Epub 2009 Aug 5.

Van der Velden VH, Corral L, Valsecchi MG, Jansen MW, De Lorenzo P, Cazzaniga G, Panzer-Grümayer ER, Schrappe M, Schrauder A, Meyer C, Marschalek R, Nigro LL, Metzler M, Basso G, Mann G, Den Boer ML, Biondi A, Pieters R, Van Dongen JJ; Interfant-99 Study Group. Prognostic significance of minimal residual disease in infants with acute lymphoblastic leukemia treated within the Interfant-99 protocol. Leukemia. 2009 Jun;23(6):1073-9. Epub 2009 Feb 12.

Pieters R, Schrappe M, De Lorenzo P, Hann I, De Rossi G, Felice M, Hovi L, LeBlanc T, Szczepanski T, Ferster A, Janka G, Rubnitz J, Silverman L, Stary J, Campbell M, Li CK, Mann G, Suppiah R, Biondi A, Vora A, Valsecchi MG. A treatment protocol for infants younger than 1 year with acute lymphoblastic leukaemia (Interfant-99): an observational study and a multicentre randomised trial. Lancet. 2007 Jul 21;370(9583):240-50.

Pieters R, Schrappe M, de Lorenzo P, et al.: Outcome of infants less than one year of age with acute lymphoblastic leukemia treated with the Interfant-99 protocol. [Abstract] Blood 108 (11): A-145, 2006.

Study ID Numbers:	CDR0000068529, ICU-INTERFANT99, UKCCSG-LK-1999-05, EU-20063, EU-20588
Study First Received:	May 6, 2001
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00015873 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Prednisone
Anti-Infective Agents
Cyclosporine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
6-Mercaptopurine
Hormones
Cyclosporins
Therapeutic Uses
Abortifacient Agents

Methotrexate
Etoposide
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Thioguanine
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009