Stage IV Melanoma Clinical Trial
Official title:
Phase II Trial of Interleukin-12 (NSC #672423, IND #6798) Followed by Interferon Alfa-2B in Patients With Metastatic Malignant Melanoma
Verified date | June 2013 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | July 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cancer and Leukemia Group B | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | Up to 2 years | No | |
Primary | PFS | From registration until time of documented progression of disease or death from any cause, assessed up to 2 years | No |
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