Rituximab and Interleukin-12 in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma

In brief

Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-12 may kill more cancer cells. This randomized phase II trial is comparing how well giving rituximab together with two different schedules of interleukin-12 works in treating patients with B-cell non-Hodgkin lymphoma.

Key facts

Study ID

NCT00026182

Run by

National Cancer Institute (NCI)

People needed

99

Starts

2001-10-01

Last updated by the study team

2013-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma
• Previously treated low-grade lymphoma considered incurable with standard therapy
• Grade I or II follicular lymphoma*
• Lymphoplasmacytic lymphoma*
• Small lymphocytic lymphoma*
• Nodal marginal zone lymphoma*
• Extranodal marginal zone lymphoma of MALT type*
• Splenic marginal zone lymphoma*
• Previously treated mantle cell lymphoma allowed
• Meets one of the following criteria for measurable disease:
• Bidimensional diameter at least 1.5 cm by 1.5 cm on physical exam
• At least 2 cm in one dimension by CT scan, MRI, or plain radiograph imaging
• Palpable spleen at least 5 cm below the left costal margin
• No CNS involvement by lymphoma
• Performance status - ECOG 0-1
• At least 12 weeks
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 75,000/mm\^3
• Hemoglobin ≥ 8 g/dL
• Bilirubin ≤ 3 times upper limit of normal (ULN)
• AST and ALT ≤ 3 times ULN
• Alkaline phosphatase ≤ 3 times ULN
• Creatinine ≤ 2 times ULN
• No New York Heart Association class III or IV heart disease
• No history of angina

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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