Large Cell Lymphoma Pilot Study III

This study has been completed.
Sponsor:
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187070
First received: September 12, 2005
Last updated: May 6, 2008
Last verified: May 2008
  Purpose

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


Condition Intervention
Lymphoma, Large Cell
Lymphoma, Non-Hodgkin
Drug: Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Vinblastine
Procedure: Stem cell transplant,
Radiation: Radiation Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Large Cell Lymphoma, Pilot Study III

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: December 1997
Study Completion Date: July 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 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.

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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187070

Locations
United States, Tennessee
St. Jude Children's Reaearch Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: John T. Sandlund, M.D. St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: John T. Sandlund , M.D./Principal Investigator, St.Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187070     History of Changes
Other Study ID Numbers: LCLIII
Study First Received: September 12, 2005
Last Updated: May 6, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Dexamethasone
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on October 20, 2014