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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies, Monoclonal; Bortezomib; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed low-grade, follicular B-cell, or mantle cell non-Hodgkin's lymphoma

• Bone marrow biopsy required for pretreatment evaluation

• Unilateral bone marrow biopsy allowed

• Core biopsies allowed if they contain adequate tissue for primary diagnosis and immunophenotyping

• Relapsed or refractory disease as defined by disease progression after initial complete response (CR) or failure to achieve CR

• No bone marrow involvement ≥ 25% within the past 30 days

• No pleural effusion or significant ascites

• No active CNS involvement

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 3 months

• Platelet count ≥ 100,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• AST ≤ 2.5 times upper limit of normal (ULN)

• Total bilirubin ≤ 2.5 times ULN

• Creatinine clearance ≥ 50 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Hepatitis B surface antigen negative

• No current infection with hepatitis B virus

• No HIV positivity

• No neuropathy or neuropathic pain ≥ grade 2

• No history of allergic reaction to boron or mannitol

• No active serious infection or medical or psychiatric illness that would preclude study therapy

• No other malignancy within the past 5 years except for the following:

• Basal cell or squamous cell carcinoma of the skin that has been completely resected

• In situ malignancy that has been completely resected

• T1-T2a, N0, M0 prostate cancer treated with a prostatectomy or radiotherapy within the past 2 years with an undetectable PSA level

• No other condition, including any of the following:

• Myocardial infarction within the past 6 months

• New York Heart Association class III-IV heart failure

• Uncontrolled angina

• Severe uncontrolled ventricular arrhythmias

• Electrocardiographic evidence of acute ischemia or active conduction system abnormalities

PRIOR CONCURRENT THERAPY:

• Recovered from all prior therapy

• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, or surgical resection of malignancy

• No limitations on the number of prior therapies

• More than 4 weeks since prior major surgery

• More than 14 days since prior filgrastim (G-CSF) or sargramostim (GM-CSF)

• More than 14 days since prior and no other concurrent investigational agents

• Concurrent participation in a nontreatment study allowed

• No prior radioimmunotherapy