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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003210
First received: November 1, 1999
Last updated: January 22, 2013
Last verified: January 2013

November 1, 1999
January 22, 2013
February 1998
November 2003   (final data collection date for primary outcome measure)
Response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Simon's two-stage model will be used.
Not Provided
Complete list of historical versions of study NCT00003210 on ClinicalTrials.gov Archive Site
Toxicity as assessed by CTC version 2.0 [ Time Frame: Up to 5 years after completion of study treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    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
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.
Interventions:
  • Biological: recombinant interleukin-12
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
Not Provided
November 2003   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003210
NCI-2012-02264, MDA-DM-97073, N01CM17003, CDR0000066067
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Anas Younes M.D. Anderson Cancer Center
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP