Expired Study
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Chicago, Illinois 60606


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Histological or cytological diagnosis of cutaneous melanoma and clinical evidence of distant, metastatic, non-resectable regional lymphatic, or extensive in transit recurrent disease - 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 - 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 - No history of peripheral neuropathy, brain metastases or other central nervous system disease - No history of/active autoimmune disease, hemolytic anemia or concurrent requirement for corticosteroids, including topical or inhaled - 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 - No history of severe peptic ulcer disease or gastrointestinal bleeding unless there is objective evidence that the condition is inactive or resolved - No uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection - No chemotherapy, radiotherapy, or anti-hormonal therapy within three weeks prior to the initiation of therapy on this study - No prior therapy with IL-12 - 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 - No prior cytokine therapy for metastatic disease (e.g., high-dose IL-2) - No more than one prior chemotherapy regimen - CTC (ECOG) performance status 0-1 - 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 - ANC >= 1500/μL - Platelets >= 100,000/μL - Hemoglobin > 9 g/dL (may be post transfusion or may receive EPO) - U-HCG or Serum HCG Negative (if patient of child-bearing potential)


NCT ID:

NCT00026143


Primary Contact:

Principal Investigator
William Carson
Cancer and Leukemia Group B


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60606
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

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