TheranosticTrials.org

Clinical Trial · NCT00334438

Bortezomib, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory Low-Grade, Follicular, or Mantle Cell Non-Hodgkin's Lymphoma

Overview

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, and radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan in treating patients with relapsed or refractory low-grade, follicular, or mantle cell non-Hodgkin's lymphoma.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Phase

Phase 1

Contacts

Thomas C. Shea, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00334438

Drug / Compound

ibritumomab tiuxetan

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies
Chelator: tiuxetan

ibritumomab tiuxetan

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies
Chelator: tiuxetan

Eligibility

Inclusion

  • Total bilirubin ≤ 2.5 times ULN
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, or surgical resection of malignancy
  • Histologically confirmed low-grade, follicular B-cell, or mantle cell non-Hodgkin's lymphoma
  • More than 4 weeks since prior major surgery
  • Bone marrow biopsy required for pretreatment evaluation
  • More than 14 days since prior and no other concurrent investigational agents
  • Fertile patients must use effective contraception
  • Negative pregnancy test
  • ECOG performance status 0-2
  • In situ malignancy that has been completely resected
  • Uncontrolled angina
  • Severe uncontrolled ventricular arrhythmias
  • Concurrent participation in a nontreatment study allowed
  • Hepatitis B surface antigen negative
  • AST ≤ 2.5 times upper limit of normal (ULN)
  • Myocardial infarction within the past 6 months
  • Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • New York Heart Association class III-IV heart failure
  • Creatinine clearance ≥ 50 mL/min
  • Core biopsies allowed if they contain adequate tissue for primary diagnosis and immunophenotyping
  • Recovered from all prior therapy
  • Relapsed or refractory disease as defined by disease progression after initial complete response (CR) or failure to achieve CR
  • Unilateral bone marrow biopsy allowed
  • More than 14 days since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Basal cell or squamous cell carcinoma of the skin that has been completely resected
  • Platelet count ≥ 100,000/mm\^3
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm\^3

Exclusion

  • No neuropathy or neuropathic pain ≥ grade 2
  • No other malignancy within the past 5 years except for the following:
  • Not pregnant or nursing
  • No current infection with hepatitis B virus
  • No pleural effusion or significant ascites
  • No HIV positivity
  • No prior radioimmunotherapy
  • No limitations on the number of prior therapies
  • No bone marrow involvement ≥ 25% within the past 30 days
  • No other condition, including any of the following:
  • No active serious infection or medical or psychiatric illness that would preclude study therapy
  • No history of allergic reaction to boron or mannitol
  • No active CNS involvement