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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Izidore Lossos, University of Miami
ClinicalTrials.gov Identifier:
NCT00453102
First received: March 27, 2007
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

RATIONALE: A variety of single agent and combination chemotherapy regimens have been examined in MALT lymphomas, including oral alkylating agents, purine analogs, rituximab and combination regimens (e.g. chlorambucil, mitoxantrone, and prednisone). While these treatments lead to high rates of disease control, the majority of patients relapse and progress over time and disseminated MZLs are considered incurable. Radiotherapy in localized MALT and nodal MZL frequently results in long-term local control and prolonged progression-free survival (PFS). However, distant relapses are observed in 10% to 15% of patients with extranodal MALT lymphomas treated with radiotherapy, suggesting the presence of occult dissemination already at the time of initial diagnosis.

Radioimmunotherapy with 90yttrium (90Y) ibritumomab tiuxetan (Zevalin) is currently approved for treatment of patients with relapsed or refractory low grade or follicular NHLs and previously untreated follicular lymphoma who achieve a partial or complete response to first-line chemotherapy. Considering the excellent local control of MZLs with radiotherapy, targeted delivery of radiation by radioimmunotherapy may be the optimal approach for patients with untreated disseminated MZL and even for patients with localized MZL in whom occult distance disease may be present

PURPOSE: Examine efficacy of yttrium Y 90 ibritumomab tiuxetan in patients with untreated newly diagnosed 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:

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 90Y 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 on day 1. Patients receive rituximab IV follow by 90Y ibritumomab tiuxetan IV push on day 7, 8, or 9.

After the completion of study treatment, patients will be seen in clinic every 2 weeks for the first 12 weeks. Then patients will be followed every 3 months for 2 years and then every 6 months for next 3 years or until disease progression.

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

Additional Information:
No publications provided

Responsible Party: Izidore Lossos, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00453102     History of Changes
Other Study ID Numbers: 20060078, SCCC-2005133, WIRB-20060249
Study First Received: March 27, 2007
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014