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Large Cell Lymphoma, Pilot Study III


N/A
N/A
18 Years
Not Enrolling
Both
Lymphoma, Large Cell, Lymphoma, Non-Hodgkin

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Trial Information

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.

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

July 2001

Safety Issue:

Yes

Principal Investigator

John T. Sandlund, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

LCLIII

NCT ID:

NCT00187070

Start Date:

December 1997

Completion Date:

July 2001

Related Keywords:

  • Lymphoma, Large Cell
  • Lymphoma, Non-Hodgkin
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin

Name

Location
St. Jude Children's Reaearch Hospital Memphis, Tennessee  38105