Melanoma Clinical Trial
Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab for Metastatic Melanoma
Summary
A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI).
Full Description
A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy (Temodar,Cisplatin, Velban,IL2 and IFN)plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)
Eligibility Criteria
Inclusion Criteria:
Stage 4 or unresectable stage 3 metastatic melanoma with or without measurable disease
Age 18-70 years old
Adequate pulmonary and cardiac function for high-dose IL-2
PS 0-2
Previous ipilimumab therapy will not exclude patients, but patients with previous ipilimumab will have separate efficacy analysis
Exclusion Criteria:
Brain metastases
Creatinine > 2x ULN; bilirubin > 3, WBC < 3500, Platelets < 100,000, Hgb < 9
Another active malignancy
Gastrointestinal tract metastases except rectal metastases or primary are allowable
Previous therapy for metastatic disease with chemotherapy of duration over 3 months or with high-dose interleukin-2
History of colitis or autoimmune disease such as lupus or rheumatoid arthritis
Bevacizumab-related contraindications: Hemoptysis or history of severe bleeding, uncontrolled hypertension, proteinuria with protein/creatinine ratio > 1, acute myocardial infarction within 6 months
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There is 1 Location for this study
San Francisco California, 94115, United States
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