Combination Chemotherapy in Treating Pediatric Patients With Stage III or IV Non-Hodgkin's Lymphoma

Lymphoma Clinical Trial

Official title:

LSA5 PROTOCOL FOR THE TREATMENT OF ADVANCED PEDIATRIC AND ADOLESCENT NON-HODGKIN'S LYMPHOMA (NHL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002691
• Other study ID #: 95-065
• Secondary ID: CDR0000064426NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 24, 2013
• Start date: August 1995
• Est. completion date: June 2000

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and using drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating pediatric patients with stage III or stage IV non-Hodgkin's lymphoma.

Description:

OBJECTIVES: I. Assess the feasibility of treating all histologic subgroups of pediatric non-Hodgkin's lymphoma on one protocol, with the addition of asparaginase during the induction and consolidation phases for diffuse lymphoblastic lymphoma and T-cell, large noncleaved cell diffuse lymphoma. II. Assess whether intensification of cyclophosphamide during induction therapy will achieve a complete response rate of 95% in 1 to 1.5 months for all histologies. III. Assess whether achieving remission induction in 1 month, administering cytarabine/methotrexate by continuous infusion during consolidation therapy, and increasing the number of intrathecal methotrexate injections throughout protocol therapy decreases central nervous system relapse in these patients. IV. Assess whether a 5-year recurrence-free survival of 85% is achievable for all histologies on this protocol. V. Assess whether duration of maintenance chemotherapy may be stratified by stage and histology of disease to avoid unnecessarily prolonged chemotherapy.

OUTLINE: The following acronyms are used: ARA-C Cytarabine, NSC-63878 ASP Asparaginase, NSC-109229 CF Leucovorin, NSC-3590 CTX Cyclophosphamide, NSC-26271 DM Dexamethasone, NSC-34521 DNR Daunorubicin, NSC-82151 G-CSF Granulocyte Colony-Stimulating Factor, NSC-614629 LBL Lymphoblastic Lymphoma LCALKi1B Large Cell Anaplastic B-cell Lymphoma LCALKi1T Large Cell Anaplastic T-cell Lymphoma LCL Large Cell Lymphoma Mesna Mercaptoethane Sulfonate, NSC-113891 MTX Methotrexate, NSC-740 TMP-SMX Trimethoprim-Sulfamethoxazole VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 Induction: 2-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy followed by 2- or 3-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy. Part I: CTX/DNR; plus IT ARA-C; followed by Part II: DM/VCR; plus ASP for patients with LBL, T-cell LCL, or LCALKi1T; plus IT MTX. Consolidation: 2- or 3-Drug Combination Systemic Chemotherapy with Leucovorin Rescue followed by 2- or 3-Drug Combination Systemic Chemotherapy. Part I: ARA-C/MTX with CF; plus ASP for patients with LBL, T-cell LCL, or LCALKi1T; followed by Part II: ARA-C/VP-16; plus, for patients with LBL, T-cell LCL, or LCALKi1T. Maintenance. Single-Agent Systemic Chemotherapy with Leucovorin Rescue plus Single-Agent Intrathecal Chemotherapy followed sequentially by 3 2-Drug Combination Systemic Chemotherapy Regimens. Part I: MTX; with CF; plus IT MTX; followed by Part II: CTX/VCR; followed by Part III: ARA-C/VP-16; followed by Part IV: DNR/DM.

PROJECTED ACCRUAL: 25 patients/stratum are expected to be accrued over 3 years. This study will be reviewed for early closure if more than 1 patient has PD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2000
• Est. primary completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• filgrastim

Drug:
• asparaginase

• cyclophosphamide

• cytarabine

• daunorubicin hydrochloride

• dexamethasone

• etoposide

• leucovorin calcium

• mesna

• methotrexate

• vincristine sulfate

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States,