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

Phase 2

Completed

• Conditions: Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma

• Registration Number: NCT00003210
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 1998-02
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-08-12
• Study First Posted: 2003-08-13
• Primary Completion: 2003-11
• Study Completion: 2003-11
• Status Verified: 2013-01
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate	Up to 5 years	Simon's two-stage model will be used.

Secondary Outcome Measures

Name	Time	Method
Toxicity as assessed by CTC version 2.0	Up to 5 years after completion of study treatment

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States