Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma - Full Text View

Sponsors and Collaborators:	Duke University GlaxoSmithKline
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00577629

Purpose

The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk NHL.

Condition	Intervention	Phase
Lymphoma, B-Cell	Drug: cyclophosphamide Drug: etoposide Drug: rituximab Drug: cytarabine Drug: doxorubicin Drug: tositumomab	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Cytarabine Cytarabine hydrochloride Etoposide Rituximab Sodium iodide I 131 Tositumomab Etoposide phosphate Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma

Further study details as provided by Duke University:

Primary Outcome Measures:

progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

toxicity [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
All subjects: Experimental Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar	Drug: cyclophosphamide 1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2 Drug: etoposide 300mg/m2 IV over 1 hour q12 on days 1-3 of induction for a total dose of 1.8 g/m2. Drug: rituximab 375mg/m2 qweek x 4 weeks of induction, beginning on day 1 Drug: cytarabine 3g/m2 IV over 1 hour q12 during consolidation for a total of 8 doses Drug: doxorubicin 45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation Drug: tositumomab 450mg unlabeled tositumomab over 1 hour, followed by 5mCi I-131 labeled tositomomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

Arms

Assigned Interventions

All subjects: Experimental

Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar

Drug: cyclophosphamide

1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2

Drug: etoposide

300mg/m2 IV over 1 hour q12 on days 1-3 of induction for a total dose of 1.8 g/m2.

Drug: rituximab

375mg/m2 qweek x 4 weeks of induction, beginning on day 1

Drug: cytarabine

3g/m2 IV over 1 hour q12 during consolidation for a total of 8 doses

Drug: doxorubicin

45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation

Drug: tositumomab

450mg unlabeled tositumomab over 1 hour, followed by 5mCi I-131 labeled tositomomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Untreated, biopsy proven B-cell non-Hodgkin's lymphoma
Age >/= 18 years
No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for one year. The patient cannot have been exposed to chemotherapy to treat any of these diseases for at least 3 years prior to study entry.
Meet staging studies and laboratory tests prior to induction, consolidation and radioimmunotherapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577629

Contacts

Contact: Emily Dill, RN	919- 684-4723	edmon009@mc.duke.edu
Contact: Patty Davis, RN	919-668-1026	davis043@mc.duke.edu

Locations

United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: David Rizzieri, MD

Sponsors and Collaborators

Duke University

GlaxoSmithKline

Investigators

Principal Investigator:

David Rizzieri, MD

Duke Unversity Medical Center

More Information

Duke Hematologic Malignancy Program This link exits the ClinicalTrials.gov site

Responsible Party:	Duke University Health Systems ( David Rizzieri, MD / principal investigator )
Study ID Numbers:	5762, GSK-103421
Study First Received:	December 18, 2007
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00577629
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

high risk nonhodgkins lymphoma
NHL
Bexxar
high dose chemotherapy

Study placed in the following topic categories:

Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse
Iodine-131 anti-B1 antibody
Cyclophosphamide
Etoposide phosphate
Doxorubicin
Antibodies, Monoclonal
Lymphoma, B-Cell

Lymphatic Diseases
Antibodies
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Etoposide
Lymphoma
Cytarabine
Immunoglobulins

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009