Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab for Metastatic Melanoma

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Melanoma

In brief

A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI).

Key facts

Study ID

NCT01743157

Run by

California Pacific Medical Center Research Institute

People needed

24

Starts

2010-12-01

Expected to finish

2013-05-01

Last updated by the study team

2013-08-29

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• San Francisco Oncology Associates — San Francisco, California, United States

Full record on ClinicalTrials.gov

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