Treatment for Patients With Stage III or IV Non-Hodgkin Lymphoma - Full Text View - ClinicalTrials.gov

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Treatment for Patients With Stage III or IV Non-Hodgkin Lymphoma

This study has been completed.

First Received: September 13, 2005 Last Updated: April 21, 2008 History of Changes

Sponsored by:	St. Jude Children's Research Hospital
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00187122

Purpose

The main purpose of this study is to determine if it is feasible to administer an intensified, multi-agent chemotherapy regimen for children with stage III and IV non-Hodgkin lymphoma and to find out what the toxicities are.

Condition	Intervention
Lymphoblastic Lymphoma	Drug: Vincristine Procedure: Radiation Therapy Drug: Daunomycin Drug: L-Asparaginase Drug: Cytarabine Drug: Methotrexate Drug: Mercaptopurine Drug: Etoposide Drug: Cyclophosphamide Drug: Prednisone Drug: Dexamethasone

MedlinePlus related topics: Lymphoma Radiation Therapy

Drug Information available for: Dexamethasone Cyclophosphamide 6-Mercaptopurine Prednisone Vincristine Methotrexate Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Etoposide Dexamethasone acetate Doxiproct plus Etoposide phosphate Cytarabine Dexamethasone Sodium Phosphate Vincristine sulfate Mercaptopurine L-Asparaginase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment for Newly Diagnosed Patients With Stage III/IV Non-Hodgkin Lymphoma-Study XIII (A Therapeutic Pilot Study)

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

To determine toxicity and feasibility of intensified multiagent chemotherapy and high dose methotrexate. [ Time Frame: Within first 30 days following pre-induction chemotherapy ] [ Designated as safety issue: Yes ]

Enrollment:	42
Study Start Date:	March 1993
Study Completion Date:	June 2004
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Assigned Interventions

1

See Detailed Description section for description of treatment plan.

Drug: Vincristine

See Detailed Description section for description of treatment plan.

Procedure: Radiation Therapy

See Detailed Description section for description of treatment plan.

Drug: Daunomycin

See Detailed Description section for description of treatment plan.

Drug: L-Asparaginase

See Detailed Description section for description of treatment plan.

Drug: Cytarabine

See Detailed Description section for description of treatment plan.

Drug: Methotrexate

See Detailed Description section for description of treatment plan.

Drug: Mercaptopurine

See Detailed Description section for description of treatment plan.

Drug: Etoposide

See Detailed Description section for description of treatment plan.

Drug: Cyclophosphamide

See Detailed Description section for description of treatment plan.

Drug: Prednisone

See Detailed Description section for description of treatment plan.

Drug: Dexamethasone

See Detailed Description section for description of treatment plan.

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage III or IV Lymphoblastic Lymphoma
One week or less of prior therapy, only to include steroids, vinca alkaloids, and emergency radiation therapy to the mediastinum in those with severe respiratory.

Exclusion criteria:

Patients with superior vena cava syndrome, significant compression of the trachea requiring more than 40% oxygen or having significant dyspnea at normal activity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187122

Locations

United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators

Principal Investigator:

Raul C. Ribeiro, M.D.

St. Jude Children's Research Hospital

More Information

Additional Information:

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	St.Jude Children's Research Hospital ( Raul C. Ribeiro, M.D./Principal Investigator )
Study ID Numbers:	NHL13
Study First Received:	September 13, 2005
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00187122 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:

Non-Hodgkin
Lymphoma

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Antimetabolites
Daunorubicin
Prednisone
Leukemia, Lymphoid
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Cyclophosphamide
6-Mercaptopurine
Hormones
Lymphoblastic Lymphoma
Etoposide phosphate

Lymphoma, Small Cleaved-cell, Diffuse
Anti-Bacterial Agents
Leukemia
Methotrexate
Alkylating Agents
Lymphoma
Etoposide
Dexamethasone acetate
Cytarabine
Acute Lymphoblastic Leukemia
Asparaginase
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Antineoplastic Agents, Hormonal
Vincristine

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
6-Mercaptopurine
Hormones
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents

Nucleic Acid Synthesis Inhibitors
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Neoplasms
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic
Antimetabolites
Daunorubicin
Leukemia, Lymphoid

ClinicalTrials.gov processed this record on May 07, 2009

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