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

Metastatic Melanoma Clinical Trial

— BBI  

Official title:

A Phase I-II Study of Treatment of Metastatic Melanoma Using Induction Therapy With Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab (BBI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743157
• Other study ID #: BBI Total Therapy
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 4, 2011
• Last updated: August 28, 2013
• Start date: December 2010
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Drug:
• Biochemo + bevacizumab then ipilimumab
Bevacizumab 7.5mg/kg week 1,repeat weeks 4,7,10 (cycles 2, 3, & 4)

Locations

Country	Name	City	State
United States	San Francisco Oncology Associates	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

3. Minor DR, Wang W, Kashani-Sabet: Concurrent bevacizumab (BEV) with biochemotherapy (BIO) followed by ipilimumab for advanced melanoma: a phase I-II trial. J Clin Onc 2013 (suppl; abstr e200001)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy and Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)	Determine the incidence of grade 4 bevacizumab-related toxicities and grade 3 proteinuria when bevacizumab is given with biochemotherapy to patients with metastatic melanoma for up to 3 years.	Primary Objective
Secondary	A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy and Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)	Compare median and overall progression-free survival to previously published historical control group of 135 patients receiving biochemotherapy followed by pulse IL-2, and also patients in the study of Weber et al (Reference 9) of ipilimumab in previously untreated patients for up to 4 years.	Secondary Objective