Brief Title
Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease
Official Title
A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response rate
Secondary Outcome
Toxicity as assessed by CTC version 2.0
Condition
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Intervention
recombinant interleukin-12
Study Arms / Comparison Groups
Treatment (interleukin-12)
Description: Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
105
Start Date
February 1998
Completion Date
November 2003
Primary Completion Date
November 2003
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
Gender
All
Ages
16 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Anas Younes, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00003210
Organization ID
NCI-2012-02264
Secondary IDs
NCI-2012-02264
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Anas Younes, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
January 2013