Large Cell Lymphoma Pilot Study III

Study Overview
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Brief Summary
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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
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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

Official Title
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Large Cell Lymphoma, Pilot Study III

Conditions
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Lymphoma, Large Cell, Lymphoma, Non-Hodgkin

Intervention / Treatment
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* Drug: Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Vinblastine
* Procedure: Stem cell transplant,
* Radiation: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Vinblastine<br>* See Detailed Description section for details of treatment interventions.<br>Procedure: Stem cell transplant,<br>* See Detailed Description section for details of treatment interventions.<br>Radiation: Radiation Therapy<br>* See Detailed Description section for details of treatment interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | July 2001 |