Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00012298
Phase
PHASE1/PHASE2
Status
Terminated

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 Grade 3 Follicular Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Waldenström Macroglobulinemia

Eligibility Criteria

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

Interventions

  • rituximab — BIOLOGICAL
    Given IV
  • yttrium Y 90 ibritumomab tiuxetan — BIOLOGICAL
    Given IV
  • indium In 111 ibritumomab tiuxetan — BIOLOGICAL
    Given IV
  • oprelvekin — BIOLOGICAL
    Given subcutaneously
  • filgrastim — BIOLOGICAL
    Given subcutaneously

Study Details

Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibody therapy and rituximab with and without filgrastim and interleukin-11 in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal antibodies can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Biological therapies such as filgrastim and interleukin-11 use different ways to stimulate the immune system and stop cancer cells from growing.

Key Dates

Start date
Apr 30, 2001
Status verified
Jul 2018
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010

Study Design

Enrollment
81 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (radiolabeled monoclonal antibody therapy)
    Patients receive rituximab IV on days 1 and 8, indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1, and yttrium Y 90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) and interleukin-11 SC until blood counts recover.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I) [ Time Frame: At 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MN

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