We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00187122
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 23, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment for Newly Diagnosed Patients With Stage III/IV Non-Hodgkin Lymphoma-Study XIII (A Therapeutic Pilot Study)
Study Start Date : March 1993
Primary Completion Date : June 2004
Study Completion Date : June 2004


Arms and Interventions

Arm Intervention/treatment
1
See Detailed Description section for description of treatment plan.
Drug: Vincristine
See Detailed Description section for description of treatment plan.
Other Name: Oncovin®, Vincasar Pfs®
Procedure: Radiation Therapy
See Detailed Description section for description of treatment plan.
Drug: Daunomycin
See Detailed Description section for description of treatment plan.
Other Name: Cerubidine®
Drug: L-Asparaginase
See Detailed Description section for description of treatment plan.
Other Name: Elspar®, Kidrolase®
Drug: Cytarabine
See Detailed Description section for description of treatment plan.
Other Name: Cytosar-U®
Drug: Methotrexate
See Detailed Description section for description of treatment plan.
Other Name: Rheumatrex®, TrexallTM
Drug: Mercaptopurine
See Detailed Description section for description of treatment plan.
Other Name: Purinethol ®
Drug: Etoposide
See Detailed Description section for description of treatment plan.
Other Name: Toposar®, VePesid®, Etopophos®
Drug: Cyclophosphamide
See Detailed Description section for description of treatment plan.
Other Name: Cytoxan®, Neosar®
Drug: Prednisone
See Detailed Description section for description of treatment plan.
Other Name: Deltasone®, Liquid Pred®, Meticorten®, Orasone®
Drug: Dexamethasone
See Detailed Description section for description of treatment plan.
Other Name: Decadron, Diodex, Hexadrol, Maxidex


Outcome Measures

Primary Outcome Measures :
  1. To determine toxicity and feasibility of intensified multiagent chemotherapy and high dose methotrexate. [ Time Frame: Within first 30 days following pre-induction chemotherapy ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Raul C. Ribeiro, M.D./Principal Investigator, St.Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187122     History of Changes
Other Study ID Numbers: NHL13
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 23, 2008
Last Verified: April 2008

Keywords provided by St. Jude Children's Research Hospital:
Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Dexamethasone
Prednisone
Cyclophosphamide
Methotrexate
Etoposide
Cytarabine
Vincristine
Asparaginase
6-Mercaptopurine
Daunorubicin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists