Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL

• Status: Completed
• Trial end date: 2014-10-10
• Target enrollment: 0
• Participant gender: All

Summary

Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, 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. Giving bortezomib together with rituximab may kill more cancer cells.

This phase II trial is studying how well giving bortezomib together with rituximab works as first-line therapy in treating patients with low-grade B-cell non-Hodgkin's lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: Robert H. Lurie Cancer Center
• Treatments: Bortezomib; Rituximab

Criteria

Inclusion Criteria:

• Histologically confirmed low-grade B-lymphocyte non-Hodgkins lymphoma

• Life expectancy > 12 months

Exclusion Criteria:

• No known history of HIV infection

• No other active infection

• No peripheral neuropathy ≥ grade 2 within the past 14 days

• No uncontrolled hypertension

• None of the following cardiac conditions:

• Myocardial infarction within the past 6 months

• No heart failure

• Uncontrolled angina

• Severe uncontrolled ventricular arrhythmias

• Electrocardiographic evidence of acute ischemia

• Active conduction system abnormalities

• No serious medical or psychiatric illness that would preclude study compliance

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior therapy for non-Hodgkins lymphoma

• No prior bortezomib or rituximab

• At least 3 weeks since prior chemotherapy, radiation therapy, immunotherapy, systemic anticancer biologic therapy, or anticancer hormonal therapy

• At least 2 weeks since prior investigational drugs

• No other concurrent systemic cytotoxic chemotherapy or investigational agents + No leukemia