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

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: April 14, 2015
Last verified: January 2013
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.

Condition Intervention Phase
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
Biological: recombinant interleukin-12
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Simon's two-stage model will be used.

Secondary Outcome Measures:
  • Toxicity as assessed by CTC version 2.0 [ Time Frame: Up to 5 years after completion of study treatment ] [ Designated as safety issue: Yes ]

Enrollment: 105
Study Start Date: February 1998
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: recombinant interleukin-12
Given subcutaneously
Other Names:
  • cytotoxic lymphocyte maturation factor
  • IL-12
  • interleukin-12
  • natural killer cell stimulatory factor
  • Ro 24-7472
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:


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.


Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003210

United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Anas Younes M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00003210     History of Changes
Other Study ID Numbers: NCI-2012-02264, NCI-2012-02264, CDR0000066067, NCI-T97-0050, DM-97073, T97-0050, N01CM17003
Study First Received: November 1, 1999
Last Updated: April 14, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Mycosis Fungoides
Sezary Syndrome
Waldenstrom Macroglobulinemia
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms, Plasma Cell processed this record on November 30, 2015