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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Melanoma

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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