Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma - Full Text View

Sponsor:	Institut Gustave Roussy
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006455

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. It is not yet known which combination chemotherapy regimen is more effective for treating anaplastic large cell lymphoma.

PURPOSE: This randomized phase III trial is studying several different regimens of combination chemotherapy to compare how well they work in treating children with anaplastic large cell lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: leucovorin calcium Drug: methotrexate Drug: therapeutic hydrocortisone Drug: vinblastine sulfate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Dexamethasone Hydrocortisone acetate Cyclophosphamide Hydrocortisone Leucovorin Methotrexate Cytarabine hydrochloride Doxorubicin Doxorubicin hydrochloride Etoposide Citrovorum factor Dexamethasone acetate Doxiproct plus Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Etoposide phosphate Hydrocortisone 21-sodium succinate Vinblastine sulfate Cytarabine Hydrocortisone cypionate Vinblastine Leucovorin Calcium Dexamethasone Sodium Phosphate Cortisol succinate Ifosfamide Cortisol 21-phosphate Folinic acid calcium salt pentahydrate

U.S. FDA Resources

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

Primary Outcome Measures:

Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Complete remission achieved after treatment course B3 and lasting ≥ 4 weeks [ Designated as safety issue: No ]
Short- and long-term toxicity [ Designated as safety issue: Yes ]
Nonlymphoma related death and early deaths (excluding deaths occurring after second-line treatment for failure or relapse) [ Designated as safety issue: No ]
CNS relapses [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	December 1999

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven standard-risk (SR) or high-risk (HR) anaplastic large cell lymphoma
- SR disease defined by no involvement of the skin, mediastinum, liver, spleen, or lung
- HR disease defined by any of the following:
  - Biopsy proven skin lesions (except skin lesions overlying an involved node or isolated skin disease)
  - Mediastinal involvement by x-ray or CT scan
  - Involvement of the liver (enlarged by at least 5 cm and/or nodular), spleen (enlarged and/or nodular), or lung (biopsy not needed for obvious lesions)
Histologic or cytologic slides must be available for national pathology review for all patients not meeting the classical criteria for diagnosis (typical histopathology, immunohistochemistry: CD30 positive, endomysial antibody positive, nucleophosmin negative, anaplastic lymphoma kinase (ALK) positive (if available), null or T-immunophenotype) unless proven t(2;5)
Must enroll within 1 week prior to beginning study regimen A
No CNS involvement (CSF or cerebral tumor)
First randomization (SR or HR disease):
- Must have begun prephase therapy
- No isolated primary skin disease
- No low-risk disease defined as completely resected stage I disease
Second randomization (HR disease only):
- Must have completed first randomization therapy without disease progression

PATIENT CHARACTERISTICS:

Age:

Under 22

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics

Hepatic:

See Disease Characteristics

Renal:

Not specified

Pulmonary:

See Disease Characteristics

Immunologic:

No congenital immunodeficiency
No AIDS

Other:

No prior malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Prior corticosteroids for anaplastic large cell lymphoma allowed if given for no more than 8 days

Radiotherapy:

Not specified

Surgery:

No prior organ transplantation

Other:

No other prior therapy for anaplastic large cell lymphoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006455

Locations

Austria
St. Anna Children's Hospital
Vienna, Austria, A-1090
Belgium
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
France
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
Kinderklinik
Giessen, Germany, D-35385
Italy
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Netherlands
Dutch Childhood Leukemia Study Group
Den Haag, Netherlands, 2504 AM
Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Sweden
Karolinska University Hospital - Huddinge
Stockholm, Sweden, S-171 76
Switzerland
University Children's Hospital
Zurich, Switzerland, CH-8032
United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ

Sponsors and Collaborators

Institut Gustave Roussy

Investigators

Study Chair:

Laurence Brugieres, MD

Institut Gustave Roussy

More Information

Additional Information:

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

Publications:

Attarbaschi A, Mann G, Rosolen A, Williams D, Uyttebroeck A, Marky I, Lamant L, Horibe K, Wrobel G, Beishuizen A, Wössmann W, Reiter A, Mauguen A, Le Deley MC, Brugières L; European Intergroup for Childhood Non-Hodgkin Lymphoma (EICNHL) ALCL99 Trial. Limited stage I disease is not necessarily indicative of an excellent prognosis in childhood anaplastic large cell lymphoma. Blood. 2011 May 26;117(21):5616-9. Epub 2011 Mar 28.

Wrobel G, Mauguen A, Rosolen A, Reiter A, Williams D, Horibe K, Brugières L, Le Deley MC; European Inter-Group for Childhood, Non-Hodgkin Lymphoma (EICNHL). Safety assessment of intensive induction therapy in childhood anaplastic large cell lymphoma: report of the ALCL99 randomised trial. Pediatr Blood Cancer. 2011 Jul 1;56(7):1071-7. Epub 2011 Jan 28.

Le Deley MC, Rosolen A, Williams DM, Horibe K, Wrobel G, Attarbaschi A, Zsiros J, Uyttebroeck A, Marky IM, Lamant L, Woessmann W, Pillon M, Hobson R, Mauguen A, Reiter A, Brugières L. Vinblastine in children and adolescents with high-risk anaplastic large-cell lymphoma: results of the randomized ALCL99-vinblastine trial. J Clin Oncol. 2010 Sep 1;28(25):3987-93. Epub 2010 Aug 2.

ClinicalTrials.gov Identifier:	NCT00006455 History of Changes
Other Study ID Numbers:	CDR0000068133, FRE-IGR-ALCL99, EU-20031, NHL2000/06
Study First Received:	November 6, 2000
Last Updated:	August 25, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I childhood anaplastic large cell lymphoma
stage II childhood anaplastic large cell lymphoma
stage III childhood anaplastic large cell lymphoma
stage IV childhood anaplastic large cell lymphoma
recurrent childhood anaplastic large cell lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, T-Cell
Cyclophosphamide
Cytarabine
Methotrexate

Ifosfamide
Isophosphamide mustard
Dexamethasone
Doxorubicin
Etoposide
Vinblastine
Dexamethasone acetate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Dexamethasone 21-phosphate
BB 1101
Leucovorin
Levoleucovorin
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 12, 2012