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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00026182
Phase
PHASE2
Status
Completed

Conditions

  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    Given IV
  • recombinant interleukin-12 — BIOLOGICAL
    Given SC
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • questionnaire administration — OTHER
    Ancillary studies
  • quality-of-life assessment — PROCEDURE
    Ancillary studies

Study Details

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 Dates

Start date
Oct 31, 2001
Status verified
Aug 2013
Primary completion
Feb 28, 2005

Study Design

Enrollment
99 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (rituximab and recombinant interleukin-12)
    Patients receive rituximab IV on days 1, 8, 15, and 22. Patients receive interleukin-12 SC twice weekly beginning on day 2 and continuing until disease progression.
  • Experimental: Arm II (rituximab and recombinant interleukin-12)
    Patients receive rituximab as in arm I. Patients are evaluated at week 12. Patients with stable or progressive disease receive interleukin-12 SC twice weekly until disease progression or for 24 weeks. Patients with a complete or partial response after rituximab are monitored until disease progression and then begin interleukin-12 SC twice weekly until further disease progression.

Primary Outcome Measure

Objective response [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
North Central Cancer Treatment GroupRochesterMinnesota55905-

Find similar trials in Rochester, MN

By research site
North Central Cancer Treatment Group· Rochester, MN

Related Studies