Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Stopped early · Phase 1/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 Grade 3 Follicular Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia
In brief
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 facts
- Study ID
- NCT00012298
- Run by
- National Cancer Institute (NCI)
- People needed
- 81
- Starts
- 2001-04-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2018-08-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically proven relapsed or refractory low-grade or follicular CD+ non-Hodgkin lymphoma, including 1 of the following:
- Small lymphocytic lymphoma
- Lymphoplasmacytoid lymphoma
- Follicular center lymphoma (grades I, II, and III)
- Extranodal marginal zone B-cell lymphoma
- Nodal marginal zone B-cell lymphoma
- Splenic marginal zone B-cell lymphoma (monocytoid B-cell lymphoma)
- Less than 25% bone marrow involvement of cellular marrow with lymphoma by bilateral bone marrow aspirate and biopsy
- ECOG performance status 0-2
- Bidimensionally measurable disease with at least 1 lesion >= 2 cm in the greatest diameter
- No prior myeloablative therapy with autologous or allogeneic bone marrow transplantation or peripheral blood stem cell support
- No concurrent corticosteroid therapy, except prednisone (or equivalent) for adrenal failure or < 20mg of prednisone daily
- No prior external beam radiotherapy to >25% of active bone marrow
- More than 4 weeks since prior surgery other than diagnostic surgery
- No other concurrent myelosuppressive antineoplastic agents
- No prior radioimmunotherapy, including yttrium Y 90 ibritumomab tiuxetan or iodine I 131 monoclonal antibody tositumomab or Lym-1
- No CNS lymphoma
- No myelodysplastic syndromes or marrow chromosomal changes suggesting myelodysplasia
- No HIV or AIDS-related lymphoma
- No pleural effusion or ascites with lymphoma cells
- No active infection
- No other serious non-malignant disease that would preclude study participation
- No other active primary malignancy
- No known human anti-mouse or human anti-chimeric antibody
- No prior skin rash (e.g., Stevens-Johnsons syndrome or toxic epidermal necrolysis) from rituximab therapy
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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