NCT00187070

Large Cell Lymphoma Pilot Study III

Large Cell Lymphoma, Pilot Study III

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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. Induction 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. Consolidation 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. Maintenance chemotherapy Vinblastine 6 mg/m2 IV weekly for one year

Conditions

• Lymphoma, Large Cell
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Vinblastine	See Detailed Description section for details of treatment interventions.
PROCEDURE	Stem cell transplant,	See Detailed Description section for details of treatment interventions.
RADIATION	Radiation Therapy	See Detailed Description section for details of treatment interventions.

Timeline

• Start date: 1997-12-01
• Primary completion: 2001-07-01
• Completion: 2001-07-01
• First posted: 2005-09-16
• Last updated: 2008-05-07

Locations

1 site across 1 country: United States