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

Northwestern University

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: Rituximab; Drug: bortezomib

Study type: Interventional

Funder types: Other

Identifiers

NCT00369707

STU00005335 (Other Identifier)

NU 06H1

Details and patient eligibility

About

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.

Full description

This is a multicenter, prospective study.

• Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 of all subsequent courses. Treatment repeats every 35 days for 3 courses. Patients achieving a complete response, partial response, or stable disease proceed to maintenance therapy.
• Maintenance therapy: Beginning 6-8 weeks after induction therapy, patients receive bortezomib IV over 3-5 seconds and rituximab IV on day 1. Treatment repeats every 60 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected at baseline and periodically during study treatment.

After completion of study therapy, patients are followed every 3 months for 2 years.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Bortezomib and Rituximab

Experimental group

Description:

On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.

Treatment:

Drug: bortezomib

Drug: Rituximab