Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma

Completed · Phase 2

Conditions studied: Recurrent Melanoma, Stage IV Melanoma

In brief

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.

Key facts

Study ID

NCT00026143

Run by

National Cancer Institute (NCI)

People needed

60

Starts

2001-10-01

Last updated by the study team

2013-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Cancer and Leukemia Group B — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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