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| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma |
| Estimated Enrollment: | 400 |
| Study Start Date: | December 1999 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven standard-risk (SR) or high-risk (HR) anaplastic large cell lymphoma
HR disease defined by any of the following:
First randomization (SR or HR disease):
Second randomization (HR disease only):
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Immunologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and 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 | |||||
| Institut Gustave Roussy |
| Study Chair: | Laurence Brugieres, MD | Institut Gustave Roussy |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| 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 |
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