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	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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 Myocet 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	Recruiting
Vienna, Austria, A-1090
Contact: Helmut Gadner, MD, FRCPG 43-1-401-70-1250
Belgium
U.Z. Gasthuisberg	Recruiting
Leuven, Belgium, B-3000
Contact: Anne Uyttebroeck, MD 321-634-3841
France
Institut Gustave Roussy	Recruiting
Villejuif, France, F-94805
Contact: Laurence Brugieres, MD 33-1-4211-4180
Germany
Kinderklinik	Recruiting
Giessen, Germany, D-35385
Contact: Alfred Reiter, MD 49-641-994-3420
Italy
Azienda Ospedaliera di Padova	Recruiting
Padova, Italy, 35128
Contact: Angelo Rosolen, MD 39-049-821-3579
Netherlands
Dutch Childhood Leukemia Study Group	Recruiting
Den Haag, Netherlands, 2504 AM
Contact: Inge M. Appel, MD 31-10-463-6691
Spain
Hospital Clinico Universitario de Valencia	Recruiting
Valencia, Spain, 46010
Contact: Rafael Delgado, MD 34-96-386-2624
Sweden
Karolinska University Hospital - Huddinge	Recruiting
Stockholm, Sweden, S-171 76
Contact: Olle Bjork, MD 46-8-517-747-17
Switzerland
University Children's Hospital	Recruiting
Zurich, Switzerland, CH-8032
Contact: Felix Niggli, MD 41-44-266-7823
United Kingdom, England
Addenbrooke's Hospital	Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Denise Williams, MD 44-1223-256-298

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

No publications provided

Study ID Numbers:	CDR0000068133, FRE-IGR-ALCL99, EU-20031, NHL2000/06
Study First Received:	November 6, 2000
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00006455 History of Changes
Health Authority:	Unspecified

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:

Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Hydrocortisone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Vinblastine
Hormones
Therapeutic Uses
Abortifacient Agents
Lymphoma, Large-Cell, Anaplastic
Methotrexate

Dermatologic Agents
Etoposide
Nucleic Acid Synthesis Inhibitors
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Neoplasms
Hydrocortisone acetate
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic
Antimetabolites

ClinicalTrials.gov processed this record on November 09, 2009