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

This study has been completed.
Sponsor:
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187122
First received: September 13, 2005
Last updated: April 21, 2008
Last verified: April 2008
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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)
Arms Assigned Interventions
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.
Other Name: Radiation Therapy
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

  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
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, see Learn About Clinical Studies.

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:
No publications provided

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
Study First Received: September 13, 2005
Last Updated: April 21, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Methotrexate
Dexamethasone
Asparaginase
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on September 22, 2014