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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Simon's two-stage model will be used.
Secondary Outcome Measures:
- Toxicity as assessed by CTC version 2.0 [ Time Frame: Up to 5 years after completion of study treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 105 |
| Study Start Date: | February 1998 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Biological: recombinant interleukin-12
Given subcutaneously
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
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| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003210 History of Changes |
| Other Study ID Numbers: | NCI-2012-02264, MDA-DM-97073, N01CM17003, CDR0000066067 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hodgkin Disease Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Waldenstrom Macroglobulinemia Mycoses Mycosis Fungoides Sezary Syndrome Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoma, B-Cell, Marginal Zone |
Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Leukemia, Lymphoid Leukemia Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |
ClinicalTrials.gov processed this record on May 16, 2013