Clinical trial · Interventional
Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease
A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease
NCT00003210CI-TRIAL-00017532completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Mixed Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Small Cleaved Cell Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Adult Hodgkin Lymphoma | Adult Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Adult Immunoblastic Large Cell Lymphoma | Adult Immunoblastic Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| recombinant interleukin-12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (interleukin-12)
- description
- Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: recombinant interleukin-12
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Up to 5 years
- description
- Simon's two-stage model will be used.
Secondary outcomes (1)
- measure
- Toxicity as assessed by CTC version 2.0
- timeFrame
- Up to 5 years after completion of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * At least 3 weeks since prior chemotherapy for lymphoma * No concurrent steroid therapy * At least 3 weeks since prior endocrine therapy for lymphoma * At least 3 weeks since prior radiotherapy for lymphoma * At least 2 weeks since prior surgery
References
Publications (0)
Data not yet available
No reference posted for this study.