Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab for Metastatic Melanoma (BBI)
|ClinicalTrials.gov Identifier: NCT01743157|
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : August 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: Biochemo + bevacizumab then ipilimumab||Phase 1 Phase 2|
Access to an investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Experimental: Biochemo + Bevacizumab then Ipilimumab
Single arm: Biochemotherapy with 4 cycles at 3 week intervals of Temozolamide 150mg/m2 x4, cisplatin 20mg/m2 x 4, vinblastine 1.2mg/m2 x 4, bevacizumab 7.5-15 mg/kg x 1, interferon 5mg/m2 x5 and aldesleukin 36,18,9, % 9 miu/day over 4 days each cycle; then ipilimumab 3mg/kg q 21 days x 4, then q 3 months x 8 for total 3 years.
Drug: Biochemo + bevacizumab then ipilimumab
Bevacizumab 7.5mg/kg week 1,repeat weeks 4,7,10 (cycles 2, 3, & 4)
- A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy and Bevacizumab followed by consolidation therapy with Ipilimumab (BBI) [ Time Frame: Primary Objective ]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.
- A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy and Bevacizumab followed by consolidation therapy with Ipilimumab (BBI) [ Time Frame: Secondary Objective ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743157
|United States, California|
|San Francisco Oncology Associates|
|San Francisco, California, United States, 94115|
|Principal Investigator:||David R Minor, MD||California Pacific Medical Center|