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

NCT ID: NCT00003210

Last Updated: 2015-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-02-28
• Study Completion Date: 2003-11-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (interleukin-12)

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

Group Type: EXPERIMENTAL

recombinant interleukin-12

Intervention Type: BIOLOGICAL

Given subcutaneously

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

recombinant interleukin-12

Given subcutaneously

Intervention Type: BIOLOGICAL

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

cytotoxic lymphocyte maturation factor; IL-12; interleukin-12; natural killer cell stimulatory factor; Ro 24-7472

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anas Younes

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

NCI-2012-02264

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000066067

Identifier Type: -

Identifier Source: secondary_id

NCI-T97-0050

Identifier Type: -

Identifier Source: secondary_id

DM-97073

Identifier Type: OTHER

Identifier Source: secondary_id

T97-0050

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM17003

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-02264

Identifier Type: -

Identifier Source: org_study_id