Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma
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| ClinicalTrials.gov Identifier: NCT00002618 |
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Recruitment Status :
Completed
First Posted : July 29, 2004
Last Update Posted : July 24, 2014
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: filgrastim Drug: cytarabine Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: vincristine sulfate Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy | Phase 3 |
OBJECTIVES: I. Compare the event free survival of children with advanced stage large cell lymphoma treated with modified APO (doxorubicin/prednisone/vincristine/mercaptopurine) with or without intermediate-dose methotrexate/high dose cytarabine as maintenance therapy following induction therapy with APO. II. Characterize further the immunophenotypic and morphologic correlates of pediatric large cell lymphoma.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms, except for those with CNS disease. These patients are assigned to arm II and receive whole brain irradiation on Regimen B. Arm I: Induction (Modified APO): Patients receive vincristine IV on days 1, 8, 15, 22, and 29, doxorubicin IV over 15 minutes on days 1 and 22, prednisone three times a day on days 1-28, and methotrexate intrathecally (IT) on days 1, 8, and 22. Patients in complete remission on day 43 proceed to maintenance, those in partial remission undergo biopsy then proceed to maintenance, and those with residual disease receive radiotherapy on regimen A concurrently with maintenance. Maintenance (day 1 is day 43 of Induction): Courses of intermediate dose methotrexate/leucovorin calcium and high dose cytarabine (ID MTX/CF/HD ARA-C) and modified APO alternate every 3 weeks. Patients receive a total of 15 courses (8 of ID MTX/CF/HD ARA-C and 7 of Modified APO). ID MTX/CF/HD ARA-C: Patients receive methotrexate IV over 24 hours on day 1, leucovorin calcium IV or orally every 6 hours on days 2 and 3, cytarabine IV over 48 hours on days 2 to 4, and methotrexate IT on day 1 of courses 1, 3, and 5. Filgrastim (G-CSF) is administered beginning on day 5 and continuing until blood counts recover. Modified APO: Patients receive vincristine IV on day 1, oral mercaptopurine on days 1-5, doxorubicin IV over 15 minutes on day 1, and oral prednisone three times a day on days 1-5. Arm II: Induction: Patients receive treatment as in arm I except that patients with CNS disease also receive methotrexate IT on days 15, 29, and 36. Maintenance (day 1 is day 43 of Induction): Modified APO: as in Arm I, with methotrexate administered on day 1 of courses 1, 3, and 5 (days 1-5 for patients with CNS disease). Courses repeat every 21 days for a total of 15 courses. Patients with CNS disease begin radiotherapy on Regimen B on week 2 of maintenance. Regimen A: Patients begin radiotherapy (5 days a week for 4.5 weeks) to residual tumor on day 1 of maintenance. Regimen B: Patients receive whole brain irradiation (5 days a week for 3.1 weeks) beginning on day 1 of maintenance. Patients are followed monthly for 6 months, every 3 months for 18 months, every 6 months for 3 years, and annually thereafter.
PROJECTED ACCRUAL: A total of 242 patients will be accrued for this study over approximately 5.4 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 242 participants |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Study of Large Cell Lymphomas in Children and Adolescents: Comparison of APO vs APO + IDMTX/HDARA-C and Continuous vs Bolus Infusion of Doxorubicin |
| Study Start Date : | December 1994 |
| Actual Primary Completion Date : | September 2000 |
| Actual Study Completion Date : | September 2006 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Regimen A
Patients begin radiotherapy (5 days a week for 4.5 weeks) to residual tumor on day 1 of maintenance.
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Biological: filgrastim
Other Names:
Drug: cytarabine Other Names:
Drug: doxorubicin hydrochloride Other Names:
Drug: leucovorin calcium Other Names:
Drug: mercaptopurine Other Names:
Drug: methotrexate Other Names:
Drug: prednisone Other Names:
Drug: vincristine sulfate Other Names:
Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy |
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Active Comparator: Regimen B
Patients receive whole brain irradiation (5 days a week for 3.1 weeks) beginning on day 1 of maintenance. Patients are followed monthly for 6 months, every 3 months for 18 months, every 6 months for 3 years, and annually thereafter.
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Biological: filgrastim
Other Names:
Drug: cytarabine Other Names:
Drug: doxorubicin hydrochloride Other Names:
Drug: leucovorin calcium Other Names:
Drug: mercaptopurine Other Names:
Drug: methotrexate Other Names:
Drug: prednisone Other Names:
Drug: vincristine sulfate Other Names:
Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy |
- Event free survival [ Time Frame: Length of study ]To study whether intermediate-dose methotrexate/high-dose Ara-C (ID MTX/HDAra-C), administered during the maintenance phase can improve the event free survival (EFS) of patients with advanced-stage large cell lymphoma (LCL).
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| Ages Eligible for Study: | up to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Previously untreated large cell lymphoma, including the following histologic designations: Rappaport classification Diffuse histiocytic Mixed lymphocytic-histiocytic Working Formulation classification Diffuse large cell, cleaved and/or noncleaved Immunoblastic Diffuse, mixed small and large cell Lukes-Collins classification Diffuse large cleaved Diffuse large noncleaved Immunoblastic T or B cell True histiocytic Updated Kiel classification Cytocentric large cell Centroblastic-centrocytic T-zone Lymphoepithelioid cell (Lennert's) Immunoblastic T or B cell Large cell anaplastic Pleomorphic Centroblastic-centrocytic, diffuse Malignant histiocytosis Murphy stage III/IV HIV-associated lymphoma eligible Any degree of bone marrow involvement eligible CNS disease eligible (such patients not randomized)
PATIENT CHARACTERISTICS: Age: Under 22 Performance status: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Adequate contraception required of fertile patients
PRIOR CONCURRENT THERAPY: No prior therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002618
| United States, Kansas | |
| Via Christi Regional Medical Center-Saint Francis Campus | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| MBCCOP - LSU Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, North Carolina | |
| Memorial Mission Hospital | |
| Asheville, North Carolina, United States, 28801 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Texas | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| San Antonio Military Pediatric Cancer and Blood Disorders Center | |
| Lackland Air Force Base, Texas, United States, 78236-5300 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284 | |
| United States, Virginia | |
| Cancer Center, University of Virginia HSC | |
| Charlottesville, Virginia, United States, 22908 | |
| Puerto Rico | |
| University of Puerto Rico School of Medicine Medical Sciences Campus | |
| San Juan, Puerto Rico, 00936-5067 | |
| Switzerland | |
| Clinique de Pediatrie | |
| Geneva, Switzerland, 1211 | |
| Study Chair: | Joseph H. Laver, MD | Medical University of South Carolina |
Other Publications:
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00002618 |
| Other Study ID Numbers: |
9315 POG-9315 ( Other Identifier: Pediatric Oncology Group ) CDR0000063955 ( Other Identifier: NCI ) |
| First Posted: | July 29, 2004 Key Record Dates |
| Last Update Posted: | July 24, 2014 |
| Last Verified: | July 2014 |
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childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma AIDS-related peripheral/systemic lymphoma AIDS-related diffuse large cell lymphoma |
AIDS-related immunoblastic large cell lymphoma AIDS-related diffuse mixed cell lymphoma stage III childhood large cell lymphoma stage IV childhood large cell lymphoma |
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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leucovorin Cobalt Cytarabine Prednisone Doxorubicin Liposomal doxorubicin Methotrexate Vincristine |
Mercaptopurine Levoleucovorin Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Abortifacient Agents, Nonsteroidal |