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NCT Number: NCT00187070

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

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Key information

Conditions

Lymphoma, Large Cell Dendritic Cell Sarcoma, Interdigitating Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Jude Children's Reaearch Hospital

Memphis, Tennessee, 38105, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Vinblastine

Drug

See Detailed Description section for details of treatment interventions.

Stem cell transplant,

Procedure

See Detailed Description section for details of treatment interventions.

radiation therapy

Radiation

See Detailed Description section for details of treatment interventions.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Official study title

Large Cell Lymphoma, Pilot Study III

Important dates

Study start
1997
Primary completion
2001
Study completion
2001
First posted
Sep 16, 2005
Registry last updated
May 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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