Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease
Study Details
Study Description
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:
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Determine the response rate of interleukin-12 in previously treated patients with non-Hodgkin's lymphoma or Hodgkin's disease.
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
|
Outcome Measures
Primary Outcome Measures
- Response rate [Up to 5 years]
Simon's two-stage model will be used.
Secondary Outcome Measures
- Toxicity as assessed by CTC version 2.0 [Up to 5 years after completion of study treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Previously treated non-Hodgkin's lymphoma (all histologies except lymphoblastic and Burkitt's lymphoma) or Hodgkin's disease
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Maximum of 4 previous treatment regimens
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Measurable disease
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No CNS involvement
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Performance status - Zubrod 0-1
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Performance status - Karnofsky 80-100%
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At least 12 weeks
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Platelet count at least 75,000/mm^3
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Absolute neutrophil count greater than 1500/mm^3
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Lymphocyte count greater than 500/mm^3
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Hemoglobin at least 8.0 g/dL
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Bilirubin less than 1.5 mg/dL
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SGOT/SGPT less than 2 times normal
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Creatinine no greater than 1.6 mg/dL
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Creatinine clearance at least 60 mL/min
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No severe cardiovascular disease including active ischemic heart disease, congestive heart failure, or major arrhythmias
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No severe pulmonary disease including dyspnea with moderate to severe exertion
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HIV negative
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No active infection
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Not pregnant or nursing
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Fertile patients must use adequate contraception
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No clinically significant autoimmune disease (e.g. rheumatoid arthritis)
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No clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer
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No prior allogeneic bone marrow or stem cell transplant
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At least 3 weeks since prior biologic therapy for lymphoma
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At least 3 weeks since prior chemotherapy for lymphoma
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No concurrent steroid therapy
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At least 3 weeks since prior endocrine therapy for lymphoma
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At least 3 weeks since prior radiotherapy for lymphoma
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At least 2 weeks since prior surgery
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Anas Younes, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2012-02264
- NCI-2012-02264
- CDR0000066067
- NCI-T97-0050
- DM-97073
- T97-0050
- N01CM17003