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

NCT00187122 | Completed

• 1 other identifier: NHL13
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoblastic Lymphoma

Keywords

Non-Hodgkin; Lymphoma

Outcome Measures

Primary Outcomes (1)

• To determine toxicity and feasibility of intensified multiagent chemotherapy and high dose methotrexate.

  Within first 30 days following pre-induction chemotherapy

Study Arms (1)

1

OTHER

See Detailed Description section for description of treatment plan.

Drug: Vincristine; Procedure: Radiation Therapy; Drug: Daunomycin; Drug: L-Asparaginase; Drug: Cytarabine; Drug: Methotrexate; Drug: Mercaptopurine; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Prednisone; Drug: Dexamethasone

Interventions

Vincristine DRUG

See Detailed Description section for description of treatment plan.

Also known as: Oncovin®, Vincasar Pfs®

1

Radiation Therapy PROCEDURE

See Detailed Description section for description of treatment plan.

1

Daunomycin DRUG

See Detailed Description section for description of treatment plan.

Also known as: Cerubidine®

1

L-Asparaginase DRUG

See Detailed Description section for description of treatment plan.

Also known as: Elspar®, Kidrolase®

1

Cytarabine DRUG

See Detailed Description section for description of treatment plan.

Also known as: Cytosar-U®

1

Methotrexate DRUG

See Detailed Description section for description of treatment plan.

Also known as: Rheumatrex®, TrexallTM

1

Mercaptopurine DRUG

See Detailed Description section for description of treatment plan.

Also known as: Purinethol ®

1

Etoposide DRUG

See Detailed Description section for description of treatment plan.

Also known as: Toposar®, VePesid®, Etopophos®

1

Cyclophosphamide DRUG

See Detailed Description section for description of treatment plan.

Also known as: Cytoxan®, Neosar®

1

Prednisone DRUG

See Detailed Description section for description of treatment plan.

Also known as: Deltasone®, Liquid Pred®, Meticorten®, Orasone®

1

Dexamethasone DRUG

See Detailed Description section for description of treatment plan.

Also known as: Decadron, Diodex, Hexadrol, Maxidex

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma

Interventions

Vincristine; Radiotherapy; Daunorubicin; Asparaginase; Cytarabine; Methotrexate; Mercaptopurine; Etoposide; etoposide phosphate; Cyclophosphamide; Prednisone; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aminopterin; Pterins; Pteridines; Sulfhydryl Compounds; Sulfur Compounds; Purines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids

Study Officials

• Raul C. Ribeiro, M.D.

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 1993
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: April 23, 2008

Record last verified: 2008-04

Locations

US (1)