Official Title: “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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2001

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

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1

Primary Measures

• 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.
  • Time Frame: July 2001
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: St. Jude Children's Research Hospital

Overall Clinical Trial Officials and Contacts

John T. Sandlund, M.D. Principal Investigator St. Jude Children's Research Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00187070

Study ID Number: LCLIII

ClinicalTrials.gov Identifier: NCT00187070

Health Authority: United States: Institutional Review Board

St. Jude Children's Research Hospital