Large Cell Lymphoma Pilot Study III
Information source: St. Jude Children's Research Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma, Large Cell; Lymphoma, Non-Hodgkin
Intervention: Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Vinblastine (Drug); Stem cell transplant, (Procedure); Radiation Therapy (Radiation)
Phase: N/A
Status: Completed
Sponsored by: St. Jude Children's Research Hospital Official(s) and/or principal investigator(s):
John T. Sandlund, M.D., Principal Investigator, Affiliation: St. Jude Children's Research Hospital
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
Clinical Details
Official title: Large Cell Lymphoma, Pilot Study III
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
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
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient must be previously untreated, except for steroids or emergency radiation
therapy.
- Patient must be less than or equal to 18 years of age.
- Patient must have a histologic diagnosis of large cell Non-Hodgkin lymphoma.
- The immunophenotype of tumor cells must be either T-cell or non-B-cell, non-T-cell.
Exclusion Criteria:
- Participants with B-cell immunophenotype NHL.
Locations and Contacts
St. Jude Children's Reaearch Hospital, Memphis, Tennessee 38105, United States
Additional Information
St. Jude Children's Research Hospital
Starting date: December 1997
Ending date: July 2001
Last updated: May 6, 2008
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