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Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), February 2008

Sponsored by: 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

MedlinePlus related topics:   Cancer    Lymphoma   

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

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
Official Title:   International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma

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  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     44-1223-216-878        

Sponsors and Collaborators
Institut Gustave Roussy

Investigators
Study Chair:     Laurence Brugieres, MD     Institut Gustave Roussy    
  More Information


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

Study ID Numbers:   CDR0000068133, FRE-IGR-ALCL99, EU-20031, NHL2000/06
First Received:   November 6, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006455
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  

Study placed in the following topic categories:
Dexamethasone
Hydrocortisone
Leucovorin
Vinblastine
Cyclophosphamide
Etoposide phosphate
Lymphoma, large-cell
Lymphoma, B-Cell
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Methotrexate
Etoposide
Lymphoma
Cytarabine
Dexamethasone acetate
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Cortisol succinate
Recurrence
Doxorubicin
Folic Acid
Lymphatic Diseases
Ifosfamide
B-cell lymphomas
Anaplastic large cell lymphoma
Hydrocortisone acetate
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Isophosphamide mustard

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Antibiotics, Antineoplastic
Hormones
Vitamins
Therapeutic Uses
Abortifacient Agents
Micronutrients
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Vitamin B Complex
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Growth Substances
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on December 03, 2008




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