Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00003210


Primary Contact:

Principal Investigator
Anas Younes
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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