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

Recurrent Mantle Cell Lymphoma Clinical Trial

Official title:

A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003210
• Other study ID #: NCI-2012-02264
• Secondary ID: NCI-2012-02264CD
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: April 14, 2015
• Start date: February 1998
• Est. completion date: November 2003

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
• Hodgkin Disease
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• 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
• 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
• Sezary Syndrome
• Splenic Marginal Zone Lymphoma
• Waldenstrom Macroglobulinemia
• Waldenström Macroglobulinemia

Intervention

Biological:
• recombinant interleukin-12
Given subcutaneously

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Simon's two-stage model will be used.	Up to 5 years	No
Secondary	Toxicity as assessed by CTC version 2.0		Up to 5 years after completion of study treatment	Yes