Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma

This study has been terminated.
(Low accrual due to the approval of new drugs for use in Mantle cell lymphoma.)
Sponsor:
Collaborator:
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01497275
First received: December 20, 2011
Last updated: February 9, 2015
Last verified: February 2015
  Purpose

The purpose of this study is to evaluate the effects (good and bad) of the combination of ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory mantle cell lymphoma.

Zevalin is a monoclonal antibody that is combined with a radioactive substance and given with another monoclonal antibody called rituximab (Rituxan). It works by attaching to cancer cells and releasing radiation to damage those cells. both Zevalin and Rituxan are given in this study, along with Velcade.


Condition Intervention Phase
Mantle-Cell Lymphoma
Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating Combined Zevalin(Ibritumomab Tiuxetan)and Velcade(Bortezomib)in Relapsed/Refractory Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Response rate (Complete response + Partial response) [ Time Frame: at 24 months of treatment ] [ Designated as safety issue: No ]
    Disease will be assessed every 3 months until month 24. The Cheson criteria will be used to define response.


Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Progression-free survival will be defined as time from on-study to disease progression or death, whichever comes first

  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall survival will be defined as the time from on-study to death due to any cause.


Enrollment: 5
Study Start Date: February 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zevalin + Velcade

Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan

Other Names:

Rituxan Velcade Zevalin

Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.

Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan
Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4mCi/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
Other Names:
  • Rituxan
  • Velcade
  • Zevalin

Detailed Description:

This is a non-randomized, unblinded single arm Phase II trial to evaluate the combination of yttrium90 ibritumomab tiuxetan and bortezomib in patients with relapsed/refractory mantle cell lymphoma (MCL). Standard hematology and chemistries, imaging and bone marrow biopsies will be done.

Research tests: 17cc of blood will be collected at screen, Day 8 OR 11 and month 3. Samples will be collected and stored for future analysis. These analyses may include but are not limited to measurements of proteasome inhibition. No genetic studies will be performed on these samples. Samples will be destroyed at the end of the study.

Primary Objective Estimate the overall response rate (CR + PR) of the combination of bortezomib and ibritumomab tiuxetan in patients with relapsed/refractory mantle cell lymphoma.

Secondary Objectives

  • Estimate the progression free and overall survival in patients with relapsed/refractory mantle cell lymphoma who receive bortezomib and ibritumomab tiuxetan.
  • Assess the toxicity of the combination of bortezomib and ibritumomab tiuxetan in patients with relapsed/refractory MCL.
  Eligibility

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

Inclusion Criteria:

  • Patients with relapsed or refractory Mantle Cell lymphoma with measurable disease.
  • Age > 18 years old
  • Expected survival >/= 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at initiation of study (Appendix I).
  • Laboratory tests meet the levels specified in the protocol

Exclusion Criteria:

  • Patients must not have received chemotherapy, radiation or surgical resection of malignancy within 3 weeks of study initiation. However, if they have received nitrosurea or mitomycin C then they should not be enrolled in the study until 6 weeks after therapy was last received.
  • No limitations to number of prior therapies
  • No prior radioimmunotherapy (RIT)
  • Prior bortezomib is allowed
  • Patient must be fully recovered from all toxicities associated with prior surgery, radiation treatment, chemotherapy or immunotherapy.
  • No active, serious infection or medical or psychiatric illness likely to interfere with participation in this clinic trial
  • No known HIV infection
  • No active central nervous system (CNS) involvement
  • Bone Marrow Involvement >/= 25% within 30 days of initiation of study treatment
  • Pregnant or breast feeding
  • No patients who have received Granulocyte colony-stimulating factor (G-CSF) or Granulocyte macrophage colony-stimulating factor (GM-CSF) within the 14 days prior to initiating protocol
  • No patient who has had major surgery within the four weeks prior to initiating protocol therapy
  • No patients with pleural effusion or significant ascites
  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: NCT01497275

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Spectrum Pharmaceuticals, Inc
Investigators
Principal Investigator: Anne Beaven, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01497275     History of Changes
Other Study ID Numbers: Pro00032517
Study First Received: December 20, 2011
Last Updated: February 9, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on March 26, 2015