Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease
Completed · Phase 2
Conditions studied: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia
In brief
Phase II trial to study the effectiveness of interleukin-12 in treating patients with previously treated non-Hodgkin's lymphoma or Hodgkin's disease. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill lymphoma cells.
Key facts
- Study ID
- NCT00003210
- Run by
- National Cancer Institute (NCI)
- People needed
- 105
- Starts
- 1998-02-01
- Expected to finish
- 2003-11-01
- Last updated by the study team
- 2015-04-15
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Previously treated non-Hodgkin's lymphoma (all histologies except lymphoblastic and Burkitt's lymphoma) or Hodgkin's disease
- Maximum of 4 previous treatment regimens
- Measurable disease
- No CNS involvement
- Performance status - Zubrod 0-1
- Performance status - Karnofsky 80-100%
- At least 12 weeks
- Platelet count at least 75,000/mm\^3
- Absolute neutrophil count greater than 1500/mm\^3
- Lymphocyte count greater than 500/mm\^3
- Hemoglobin at least 8.0 g/dL
- Bilirubin less than 1.5 mg/dL
- SGOT/SGPT less than 2 times normal
- Creatinine no greater than 1.6 mg/dL
- Creatinine clearance at least 60 mL/min
- No severe cardiovascular disease including active ischemic heart disease, congestive heart failure, or major arrhythmias
- No severe pulmonary disease including dyspnea with moderate to severe exertion
- HIV negative
- No active infection
- Not pregnant or nursing
- Fertile patients must use adequate contraception
- No clinically significant autoimmune disease (e.g. rheumatoid arthritis)
- No clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer
- No prior allogeneic bone marrow or stem cell transplant
- At least 3 weeks since prior biologic therapy for lymphoma
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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