Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
- Conditions
- Recurrent MelanomaStage IV Melanoma
- Interventions
- Biological: recombinant interleukin-12Biological: recombinant interferon alfaOther: laboratory biomarker analysis
- Registration Number
- NCT00026143
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
Phase II trial to study the effectiveness of combining interleukin-12 and interferon alfa in treating patients who have metastatic malignant melanoma. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Interferon alfa may interfere with the growth of the cancer cells. Combining interleukin-12 and interferon alfa may kill more tumor cells.
- Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the clinical response rates in patients with metastatic malignant melanoma treated with rhIL-12 and interferon alfa-2b.
II. To estimate the progression-free survival in patients with metastatic malignant melanoma treated with rhIL-12 and interferon alfa-2b.
SECONDARY OBJECTIVES:
I. To measure serum levels of interferon-gamma. II. To measure levels of JAK-STAT signaling intermediates in patient PBMCs and tumor samples.
III. To analyze interferon-alpha-induced STAT signaling in patient PBMCs. IV. To determine the expression of IFN-regulated genes in patient PBMCs and tumor tissues.
V. To determine the pattern of gene expression induced by treatment with IL-12 and interferon-alpha using DNA microarray techniques in patient PBMCs.
OUTLINE: This is a multicenter study.
Patients receive interleukin-12 IV over 5-15 seconds on day 1 and interferon alfa subcutaneously on days 2-6. Treatment repeats every 2 weeks in the absence of unacceptable toxicity. Patients are reassessed after 6 courses. Patients with a complete response receive 2 additional courses. Patients with a partial response or stable disease continue treatment in the absence of disease progression.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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Histological or cytological diagnosis of cutaneous melanoma and clinical evidence of distant, metastatic, non-resectable regional lymphatic, or extensive in transit recurrent disease
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Patients must have measurable disease; measurable disease is defined as the presence of at least one measurable lesion; if the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology; measurable lesions are defined as lesions that can be accurately measured in at least one dimension with the longest diameter >= 20 mm using conventional techniques or >= 10 mm with spiral CT scan
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Lesions that are considered intrinsically non-measurable include the following:
- Bone lesions;
- Leptomeningeal disease;
- Ascites;
- Pleural/pericardial effusion;
- Inflammatory breast disease;
- Lymphangitis cutis/pulmonis;
- Abdominal masses that are not confirmed and followed by imaging techniques;
- Lytic lesions;
- Lesions that are situated in a previously irradiated area
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No history of peripheral neuropathy, brain metastases or other central nervous system disease
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No history of/active autoimmune disease, hemolytic anemia or concurrent requirement for corticosteroids, including topical or inhaled
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No hepatitis BSAg, known HIV disease or other major active illness; patients with risk factors for HIV should be tested; patients with these illnesses are more likely to experience significant side effects from the study treatment
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No history of severe peptic ulcer disease or gastrointestinal bleeding unless there is objective evidence that the condition is inactive or resolved
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No uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection
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No chemotherapy, radiotherapy, or anti-hormonal therapy within three weeks prior to the initiation of therapy on this study
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No prior therapy with IL-12
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No prior therapy with IFN-alpha for metastatic disease (e.g., biochemotherapy); prior adjuvant therapy with IFN-a is acceptable as long as the patient remained disease-free for 12 months or longer following the last IFN-a treatment
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No prior cytokine therapy for metastatic disease (e.g., high-dose IL-2)
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No more than one prior chemotherapy regimen
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CTC (ECOG) performance status 0-1
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Non-pregnant, non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control; women of child-bearing age will undergo pregnancy testing
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ANC >= 1500/μL
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Platelets >= 100,000/μL
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Hemoglobin > 9 g/dL (may be post transfusion or may receive EPO)
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U-HCG or Serum HCG Negative (if patient of child-bearing potential)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I recombinant interleukin-12 Patients receive interleukin-12 IV over 5-15 seconds on day 1 and interferon alfa subcutaneously on days 2-6. Treatment repeats every 2 weeks in the absence of unacceptable toxicity. Patients are reassessed after 6 courses. Patients with a complete response receive 2 additional courses. Patients with a partial response or stable disease continue treatment in the absence of disease progression. Arm I recombinant interferon alfa Patients receive interleukin-12 IV over 5-15 seconds on day 1 and interferon alfa subcutaneously on days 2-6. Treatment repeats every 2 weeks in the absence of unacceptable toxicity. Patients are reassessed after 6 courses. Patients with a complete response receive 2 additional courses. Patients with a partial response or stable disease continue treatment in the absence of disease progression. Arm I laboratory biomarker analysis Patients receive interleukin-12 IV over 5-15 seconds on day 1 and interferon alfa subcutaneously on days 2-6. Treatment repeats every 2 weeks in the absence of unacceptable toxicity. Patients are reassessed after 6 courses. Patients with a complete response receive 2 additional courses. Patients with a partial response or stable disease continue treatment in the absence of disease progression.
- Primary Outcome Measures
Name Time Method Response rate Up to 2 years PFS From registration until time of documented progression of disease or death from any cause, assessed up to 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cancer and Leukemia Group B
🇺🇸Chicago, Illinois, United States