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Large Cell Lymphoma Pilot Study III

Primary Purpose

Lymphoma, Large Cell, Lymphoma, Non-Hodgkin

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Vinblastine
Stem cell transplant,
Radiation Therapy
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large Cell

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Jude Children's Reaearch Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
May 6, 2008
Sponsor
St. Jude Children's Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00187070
Brief Title
Large Cell Lymphoma Pilot Study III
Official Title
Large Cell Lymphoma, Pilot Study III
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
December 1997 (undefined)
Primary Completion Date
July 2001 (Actual)
Study Completion Date
July 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St. Jude Children's Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large Cell, Lymphoma, Non-Hodgkin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Vinblastine
Intervention Description
See Detailed Description section for details of treatment interventions.
Intervention Type
Procedure
Intervention Name(s)
Stem cell transplant,
Intervention Description
See Detailed Description section for details of treatment interventions.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
See Detailed Description section for details of treatment interventions.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John T. Sandlund, M.D.
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Reaearch Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital

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Large Cell Lymphoma Pilot Study III

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