Combination Chemotherapy in Treating Pediatric Patients With Stage III or IV Non-Hodgkin's Lymphoma
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
asparaginase
cyclophosphamide
cytarabine
daunorubicin hydrochloride
dexamethasone
etoposide
leucovorin calcium
mesna
methotrexate
vincristine sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, stage III childhood small noncleaved cell lymphoma, stage III childhood large cell lymphoma, stage IV childhood large cell lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: See General Eligibility Criteria PATIENT CHARACTERISTICS: See General Eligibility Criteria
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002691
First Posted
November 1, 1999
Last Updated
June 24, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00002691
Brief Title
Combination Chemotherapy in Treating Pediatric Patients With Stage III or IV Non-Hodgkin's Lymphoma
Official Title
LSA5 PROTOCOL FOR THE TREATMENT OF ADVANCED PEDIATRIC AND ADOLESCENT NON-HODGKIN'S LYMPHOMA (NHL)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 1995 (undefined)
Primary Completion Date
June 2000 (Actual)
Study Completion Date
June 2000 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, stage III childhood small noncleaved cell lymphoma, stage III childhood large cell lymphoma, stage IV childhood large cell lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
asparaginase
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
daunorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
mesna
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya Trippett, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combination Chemotherapy in Treating Pediatric Patients With Stage III or IV Non-Hodgkin's Lymphoma
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