Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: See General Eligibility Criteria PATIENT CHARACTERISTICS: See General Eligibility Criteria


Study is Available At:


Original ID:

95-065


NCT ID:

NCT00002691


Secondary ID:

CDR0000064426


Study Acronym:


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)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Tanya Trippett, MD
Study Chair
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:August 1995
Completion Date:June 2000
Completion Type:Actual
Primary Completion Date:June 2000
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 24, 2013
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:filgrastim
Intervention Type:Drug
Name:asparaginase
Intervention Type:Drug
Name:cyclophosphamide
Intervention Type:Drug
Name:cytarabine
Intervention Type:Drug
Name:daunorubicin hydrochloride
Intervention Type:Drug
Name:dexamethasone
Intervention Type:Drug
Name:etoposide
Intervention Type:Drug
Name:leucovorin calcium
Intervention Type:Drug
Name:mesna
Intervention Type:Drug
Name:methotrexate
Intervention Type:Drug
Name:vincristine sulfate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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