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Home > "C" Clinical Trials Conditions > Comparison of Combination Chemotherapy Regimens in Treating Children Who Have Anaplastic Large Cell Lymphoma  Comparison of Combination Chemotherapy Regimens in Treating Children Who Have Anaplastic Large Cell Lymphoma
Comparison of Combination Chemotherapy Regimens in Treating Children Who Have Anaplastic Large Cell Lymphoma
For Condition: stage 2 childhood large cell lymphoma,anaplastic large cell lymphoma,stage 4 childhood large cell lymphoma,stage 3 childhood large cell lymphoma,stage 1 childhood large cell lymphoma,recurrent childhood large cell lymphoma
Status: Recruiting
Sponsor(s): Societe Francaise Oncologie Pediatrique ,
Synopsis: 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 chemotherapyregimen is more effective for treating anaplastic large cell lymphoma. PURPOSE: Randomizedphase III trial to compare the effectiveness of different regimens of combination chemotherapy in treating children who have large cell lymphoma.
Details: OBJECTIVES: - Compare the event-free survival in children with anaplastic large cell lymphoma treated with various induction and maintenance chemotherapy regimens with or without vinblastine. - Compare the impact of different doses and schedules of methotrexate from the Berlin-Frankfurt-Munster-K2 Protocol in terms of overall survival, complete remission rate, CNS relapse rate, and nonlymphoma-related death and early death rates in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to country, vinblastine (VBL) (yes vs no), and prognostic factors (standard-risk (SR) vs high-risk (HR) disease). Beginning immediately after confirmation of diagnosis, patients receive prephase therapy comprising dexamethasone (DM) IV or orally daily on days 1 and 2 and every 12 hours on days 3-5; cyclophosphamide (CTX) IV over 1 hour on days 1 and 2; and methotrexate (MTX) intrathecally (IT), doxorubicin (DOX) IT, and hydrocortisone (HC) IT on day 1. Patients are then assigned to one of two treatment groups based on prognosis: Group 1 (SR disease): - Patients are randomized to arm I or III: - Arm I: Patients receive treatment on arm I as defined below on day 1, and then the following courses as defined below in the following order beginning on day 6: A1, B1, A2, B2, A3, and B3. - Arm III: Patients receive treatment on arm III as defined below on day 1, and then the following courses as defined below in the following order beginning on day 6: regimen AM1, BM1, AM2, BM2, AM3, and BM3. Group 2 (HR disease): - Patients are randomized to arm I or III: - Arm I: Patients receive treatment on arm I as defined below on day 1 and then course A1 as defined below on day 6. - Arm III: Patients receive treatment on arm III as defined below on day 1 and then course AM1 as defined below on day 6. - Patients without disease progression after completion of the above therapy are randomized to arm I, II, III, or IV. - Arm I: Patients receive treatment on arm I as defined below on day 1, and then the following courses as defined below in the following order after blood counts recover: B1, A2, B2, A3, and B3. - Arm II: Patients receive treatment on arm II as defined below on day 1, and then the following courses as defined below in the following order after blood counts recover: BV1, AV2, BV2, AV3, and BV3. - Arm III: Patients receive treatment on arm III as defined below on day 1, and then the following courses as defined below in the following order after blood counts recover: BM1, AM2, BM2, AM3, and BM3. - Arm IV: Patients receive treatment on arm IV as defined below on day 1, and then the following courses as defined below in the following order after blood counts recover: BMV1, AMV2, BMV2, AMV3, and BMV3. Patients are followed every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter. DEFINITIONS: - Arms I-IV are defined below: - Arm I: Patients receive lower dose MTX IV over 24 hours and MTX IT. - Arm II: Patients receive lower dose MTX IV over 24 hours and MTX IT. Patients with HR disease also receive VBL IV weekly for 1 year beginning 3 weeks after initiation of course BV3. - Arm III: Patients receive higher dose MTX IV over 3 hours without intrathecal therapy. - Arm IV: Patients receive treatment as in arm III. Patients with HR disease also receive VBL IV weekly for 1 year beginning 3 weeks after initiation of course BMV3. - Regimens A, B, AV, BV, AM, BM, AMV, and BMV are defined below: - Regimen A (courses A1, A2, and A3): Patients receive DM IV or orally every 12 hours on days 1-5; MTX IV over 24 hours on day 1; MTX IT, DOX IT, and HC IT (beginning 2-4 hours after initiation of MTX infusion) on day 1; leucovorin calcium (CF) IV rescue at 42, 48, and 54 hours after initiation of MTX infusion; ifosfamide (IFF) IV over 1 hour on days 1-5 (before initiation of MTX infusion); cytarabine (ARA-C) IV over 1 hour every 12 hours and etoposide (VP-16) IV over 2 hours once (beginning after completion of ARA-C infusion) on days 4 and 5. Each course lasts 3 weeks. - Regimen B (courses B1, B2, and B3): Patients receive DM, MTX, intrathecal therapy, and CF rescue as in regimen A. Patients also receive CTX IV over 1 hour on days 1-5 and DOX IV over 1 hour on days 4 and 5. Each course lasts 3 weeks. - Regimen AV (courses AV1, AV2, and AV3): Patients receive treatment as in regimen A and VBL IV on day 1. Each course lasts 3 weeks. - Regimen BV (courses BV1, BV2, and BV3): Patients receive treatment as in regimen B and VBL IV as in regimen AV. Each course lasts 3 weeks. - Regimen AM (courses AM1, AM2, and AM3): Patients receive DM IV or orally every 12 hours on days 1-5; MTX IV over 3 hours on day 1; and CF IV rescue every 6 hours for a total of 12 doses beginning 24 hours after initiation of MTX infusion. Patients also receive IFF, ARA-C, and VP-16 as in regimen A. Each course lasts 3 weeks. - Regimen BM (courses BM1, BM2, and BM3): Patients receive CTX and DOX as in regimen B. Patients also receive DM, MTX, and CF rescue as in regimen AM. Each course lasts 3 weeks. - Regimen AMV (courses AMV1, AMV2, and AMV3): Patients receive treatment as in regimen AM and VBL as in regimen AV. Each course lasts 3 weeks. - Regimen BMV (courses BMV1, BMV2, and BMV3): Patients receive treatment as in regimen BM and VBL as in regimen AV. Each course lasts 3 weeks. PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 5.4-6.7 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LaurenceBrugieres, Study Chair, Institut Gustave Roussy
Karolinska Hospital *Recruiting*
Stockholm, , S-171 76
Sweden
Recruiting Olle Bjork 46-8-517-74717
Dutch Childhood Leukemia Study Group *Recruiting*
Den Haag, , 2504 AM
Netherlands
Recruiting Inge Apple 00-31-10-463-6691
Universita di Padova *Recruiting*
Padova, , 35128
Italy
Recruiting Angelo Rosolen 39-049-821-3579
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Anne Uyttebroeck 321-634-3841
Addenbrooke's NHS Trust *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting Denise Williams 44-1223-216-878
Hospital Clinico Universitario de Valencia *Recruiting*
Valencia, , 46010
Spain
Recruiting Rafael Delgado 34-96-386-2624
University Children's Hospital *Recruiting*
Zurich, , CH-8032
Switzerland
Recruiting Felix Niggli 41-1-266-7823
Kinderklinik *Recruiting*
Giessen, , D-35385
Germany
Recruiting Alfred Reiter 49-641-994-3420
Institut Gustave Roussy *Recruiting*
Villejuif, , F-94805
France
Recruiting Laurence Brugieres 00-33-1-42-11-41-80
St. Anna Children's Hospital *Recruiting*
Vienna, , A-1090
Austria
Recruiting Helmut Gadner 43-1-401-70-250
Department of Children Hematology/Oncology *Recruiting*
Wroclaw, , 50345
Poland
Recruiting Janinia Jaworska 00-48-71-328-20-40
Additional Information:
Study ID Numbers: CDR0000068133; NHL2000/06,EU-20031,SFOP-ALCL99
Study Start Date:
Record last reviewed: November 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006455
Other Recurrent Childhood Large Cell Lymphoma Studies:
1. Combination Chemotherapy and Rituximab in Treating Young Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia
2. Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
3. Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma
4. Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma
5. Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent childhood large cell lymphoma Clinical Trials
Other England Clinical Trials
Other Cambridge Clinical Trials
Comparison of Combination Chemotherapy Regimens in Treating Children Who Have Anaplastic Large Cell Lymphoma
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