Large Cell Lymphoma, Pilot Study III
Secondary objectives will include documenting the toxicity associated with the treatment
regimen, and to estimate the response rates and survival of participants with large cell
lymphoma treated on this protocol.
Patients will be treated with induction, consolidation, and maintenance treatment.
MIED chemotherapy - High dose methotrexate, ifosfamide, etoposide, and dexamethasone for 2
High-dose methotrexate 8 gm/m2 on Day 1 with leucovorin rescue Ifosfamide 2 gm/m2/day on
days 2-4 (total of 3 days) Etoposide (VP-16) 200 mg/m2/day on Days 2-4 (total of 3 days)
Dexamethasone 40 mg/m2/day IV on days 1-4 (given IV or PO daily x 4) Intrathecal MHA, age
COPADM chemotherapy for 2 cycles - cyclophosphamide, vincristine, prednisone, adriamycin,
COPAM#1 High dose methotrexate (HD MTX) 5 gm/m2 IV over 4 hours on Day 1 with leucovorin
rescue; Doxorubicin 60 mg/m2 IV over 6 hours on Day 2, Vincristine 2.0 mg/m2 (2.0 mg max)
Day 1, Cyclophosphamide 500 mg/m2/day (divided every 12 hours) Days 2-4, Prednisone 60 mg/m2
(divided bid) Days 1-5, Intrathecal MHA, age adjusted dosages.
COPADM#2 - like COPADM#1 except: 1. cyclophosphamide dose increased to 1 gm/m2/day divided
every 12 hours on Days 2-4, and 2. second dose of vincristine given on Day 6.
DAC chemotherapy x 1 cycle - Dexamethasone, cytarabine, and carboplatin
Carboplatin (AUC of 8) Day 1; Ara-C 2 gm/m2/dose q12 x 2 Day 2 Dexamethasone 40 mg/m2/day
Days 1-4; ITMHA dose age adjusted.
Hematopoietic Stem Cell Transplantation - high-dose cyclophosphamide and etoposide
Involved field radiation to the primary tumor will be given over 3-4 weeks. Participants
with CNS disease at diagnosis will also receive cranial irradiation.
Vinblastine 6 mg/m2 IV weekly for one year
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To demonstrate the feasibility of delivery of a multiagent chemotherapy regimen which features a shorter, more direct approach, and includes a phase that incorporates hematopoietic stem cell support for children with large cell lymphoma.
John T. Sandlund, M.D.
St. Jude Children's Research Hospital
United States: Institutional Review Board
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