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

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ClinicalTrials.gov Identifier: NCT00002691
Recruitment Status : Completed
First Posted : July 1, 2004
Last Update Posted : June 25, 2013
Sponsor:
Information provided by:
Memorial Sloan Kettering Cancer Center

November 1, 1999
July 1, 2004
June 25, 2013
August 1995
June 2000   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002691 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy in Treating Pediatric Patients With Stage III or IV Non-Hodgkin's Lymphoma
LSA5 PROTOCOL FOR THE TREATMENT OF ADVANCED PEDIATRIC AND ADOLESCENT NON-HODGKIN'S LYMPHOMA (NHL)

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Lymphoma
  • Biological: filgrastim
  • Drug: asparaginase
  • Drug: cyclophosphamide
  • Drug: cytarabine
  • Drug: daunorubicin hydrochloride
  • Drug: dexamethasone
  • Drug: etoposide
  • Drug: leucovorin calcium
  • Drug: mesna
  • Drug: methotrexate
  • Drug: vincristine sulfate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2000
June 2000   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria

Sexes Eligible for Study: All
up to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002691
95-065
CDR0000064426 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-V95-0763
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Memorial Sloan Kettering Cancer Center
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Study Chair: Tanya Trippett, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP