Clinical trial NCT00003210: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-08-13
Enrollment: 105
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Response rate
timeFrame: Up to 5 years
Secondary outcomes:
measure: Toxicity as assessed by CTC version 2.0
timeFrame: Up to 5 years after completion of study treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Anas Younes
role: PRINCIPAL_INVESTIGATOR
References: