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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Pacific Medical Center Research Institute
• Treatments: Antibodies, Monoclonal; Bevacizumab; Interleukin-2; Ipilimumab

Criteria

Inclusion Criteria:

1. Stage 4 or unresectable stage 3 metastatic melanoma with or without measurable disease

2. Age 18-70 years old

3. Adequate pulmonary and cardiac function for high-dose IL-2

4. PS 0-2

5. Previous ipilimumab therapy will not exclude patients, but patients with previous ipilimumab will have separate efficacy analysis

Exclusion Criteria:

1. Brain metastases

2. Creatinine > 2x ULN; bilirubin > 3, WBC < 3500, Platelets < 100,000, Hgb < 9

3. Another active malignancy

4. Gastrointestinal tract metastases except rectal metastases or primary are allowable

5. Previous therapy for metastatic disease with chemotherapy of duration over 3 months or with high-dose interleukin-2

6. History of colitis or autoimmune disease such as lupus or rheumatoid arthritis

7. Bevacizumab-related contraindications: Hemoptysis or history of severe bleeding, uncontrolled hypertension, proteinuria with protein/creatinine ratio > 1, acute myocardial infarction within 6 months