A Phase I-II Study of Treatment of Metastatic Melanoma Using Induction Therapy With Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab (BBI)
18 Years
N/A
Both
Metastatic Melanoma
Trial Information
A Phase I-II Study of Treatment of Metastatic Melanoma Using Induction Therapy With Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab (BBI)
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)
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy and Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)
Outcome Description:
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.
Outcome Time Frame:
Primary Objective
Safety Issue:
Yes
Principal Investigator
David R Minor, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
California Pacific Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
BBI Total Therapy
NCT ID:
NCT01743157
Start Date:
December 2010
Completion Date:
January 2014
Related Keywords:
- Metastatic Melanoma
- Melanoma
Name | Location |
|---|---|
| San Francisco Oncology Associates | San Francisco, California 94115 |
