Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma - Full Text View

Purpose

RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. Giving yttrium Y 90 ibritumomab tiuxetan together with rituximab may be an effective treatment for marginal zone lymphoma.

PURPOSE: This phase II trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with previously untreated marginal zone lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: rituximab Drug: yttrium Y 90 ibritumomab tiuxetan	Phase II

MedlinePlus related topics:

Cancer Lymphoma

ChemIDplus related topics:

Rituximab Ibritumomab tiuxetan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label

Official Title:	Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Clinical response rate (complete response [CR], unconfirmed CR, and partial response) [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	February 2006
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Assess the clinical response rate (complete response [CR], unconfirmed CR, and partial response) in patients with previously untreated marginal zone lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab.

Secondary

Determine progression-free survival, in terms of time to relapse or progression, of patients treated with this regimen.
Determine overall survival of patients treated with this regimen.
Assess local disease control in these patients
Evaluate the safety and tolerability of this regimen in these patients.

OUTLINE: Patients receive rituximab IV and indium In 111 ibritumab tiuxetan IV over 10 minutes on day 1. Patients with acceptable biodistribution receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV on day 7, 8, or 9.

After the completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed marginal zone lymphoma (MZL)
- Extranodal, splenic, or nodal MZL
- All stages allowed
Meets 1 of the following criteria:
- Previously untreated nongastric MZL
- Gastric MZL that did not respond to antibiotic therapy given 2-6 months ago
Measurable or evaluable disease
Must not have ≥ 25% bone marrow involvement by MZL

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 6 months
Platelet count ≥ 100,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
No known HIV positivity
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after completion of study treatment
No physical or mental condition that precludes study compliance

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior or concurrent chemotherapy
No prior radiotherapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy
No concurrent corticosteroids
No other concurrent systemic antineoplastic therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453102

Locations


United States, Florida
	University of Miami Sylvester Comprehensive Cancer Center - Miami	Recruiting
	Miami, Florida, United States, 33136
	Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com

Sponsors and Collaborators

Sylvester Cancer Center

Investigators


Study Chair:	Izidore S. Lossos, MD	Sylvester Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000537500, SCCC-2005133, SCCC-20060249, SCCC-20060078
First Received:	March 27, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00453102
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue

nodal marginal zone B-cell lymphoma

splenic marginal zone lymphoma

stage III marginal zone lymphoma

stage IV marginal zone lymphoma

contiguous stage II marginal zone lymphoma

noncontiguous stage II marginal zone lymphoma

stage I marginal zone lymphoma

Study placed in the following topic categories:

Antibodies, Monoclonal

Lymphoma, B-Cell

Lymphatic Diseases

Antibodies

Immunoproliferative Disorders

Rituximab

B-cell lymphomas

Lymphoma, B-Cell, Marginal Zone

Lymphoproliferative Disorders

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immunologic Factors

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Antirheumatic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2008

Sponsored by:	Sylvester Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00453102