Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma |
- Event-free survival [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| Study Chair: | Laurence Brugieres, MD | Institut Gustave Roussy |
More Information
Additional Information:
Publications:
| 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, Non-Hodgkin Lymphoma, Large-Cell, Anaplastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell Cyclophosphamide Cytarabine Methotrexate Ifosfamide Isophosphamide mustard |
Dexamethasone Doxorubicin Etoposide Vinblastine Dexamethasone acetate Cortisol succinate Hydrocortisone acetate Hydrocortisone 17-butyrate 21-propionate Hydrocortisone Dexamethasone 21-phosphate BB 1101 Hydrocortisone-17-butyrate Leucovorin Levoleucovorin Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 16, 2013