Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Waldenström Macroglobulinemia; Recurrent Adult Hodgkin Lymphoma; Recurrent Small Lymphocytic Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Splenic Marginal Zone Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma

Treatments: Biological: recombinant interleukin-12; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: NIH

Identifiers

NCT00003210

DM-97073 (Other Identifier)

N01CM17003 (U.S. NIH Grant/Contract)

CDR0000066067

T97-0050 (Other Identifier)

NCI-T97-0050

NCI-2012-02264 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. Determine the response rate of interleukin-12 in previously treated patients with non-Hodgkin's lymphoma or Hodgkin's disease.

II. To determine the in vivo regulatory effect of interleukin-12 on Fas lingand (FasL) expression on patients' peripheral blood lymphocytes.

OUTLINE: Patients are stratified according to disease characteristics: low grade non-Hodgkin's lymphoma (follicular small cleaved, follicular mixed, small lymphocytic, and variants) versus intermediate grade non-Hodgkin's lymphoma (follicular large, diffuse large, diffuse mixed, immunoblastic, peripheral T-cell, and mantle cell) versus Hodgkin's disease.

Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 36-105 patients will be accrued for this study.

Enrollment: 105 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

105 participants in 1 patient group

Treatment (interleukin-12)

Experimental group

Description:

Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Treatment:

Other: laboratory biomarker analysis

Biological: recombinant interleukin-12