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

This study is currently recruiting participants.
Verified February 2014 by University of Miami Sylvester Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00453102
First received: March 27, 2007
Last updated: February 28, 2014
Last verified: February 2014
  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: Ibritumomab Tiuxetan
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • Clinical response rate (complete response [CR], unconfirmed CR, and partial response) [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: February 2006
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zevalin + Rituximab Drug: Rituximab
IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Drug: Ibritumomab Tiuxetan

IV injection of In-111 Zevalin® over 10 minutes on Days 1, 7, 8, 9:

0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³

Other Name: Zevalin

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
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Izidore S. Lossos, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00453102     History of Changes
Other Study ID Numbers: UMIAMI-20060078, SCCC-2005133, WIRB-20060249
Study First Received: March 27, 2007
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Rituximab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 23, 2014