Large Cell Lymphoma Pilot Study III
The main purpose of this study is to find out if it is feasible to deliver a multi-agent chemotherapy regimen which features a shorter, more intensive, immunophenotype-directed approach, and includes an intensification phase with hematopoietic stem cell support for children with large cell lymphoma
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 cycles.
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 adjusted dosages.
COPADM chemotherapy for 2 cycles - cyclophosphamide, vincristine, prednisone, adriamycin, high-dose methotrexate
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, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Lymphoma, Large Cell
Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Vinblastine, Stem cell transplant,, Radiation Therapy
St. Jude Children's Reaearch Hospital
St. Jude Children's Research Hospital
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00187070
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Congener of CYTARABINE that is metabolized to cytarabine and thereby maintains a more constant antineoplastic action.
A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)
An organoplatinum compound that possesses antineoplastic activity.
Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.
An anti-inflammatory 9-fluoro-glucocorticoid.
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