Large Cell Lymphoma Pilot Study III

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

Large Cell Lymphoma, Pilot Study III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187070
• Other study ID #: LCLIII
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: May 6, 2008
• Start date: December 1997
• Est. completion date: July 2001

Study information

• Verified date: May 2008
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2001
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large Cell
• Lymphoma, Non-Hodgkin

Intervention

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.

Locations

Country	Name	City	State
United States	St. Jude Children's Reaearch Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   St. Jude Children's Research Hospital