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

Primary Purpose

Metastatic Melanoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biochemo + bevacizumab then ipilimumab
Sponsored by
California Pacific Medical Center Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco Oncology Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biochemo + Bevacizumab then Ipilimumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 4, 2011
Last Updated
August 28, 2013
Sponsor
California Pacific Medical Center Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01743157
Brief Title
Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab for Metastatic Melanoma
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Pacific Medical Center Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biochemo + Bevacizumab then Ipilimumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Biochemo + bevacizumab then ipilimumab
Other Intervention Name(s)
Avastin,, Temodar,, Platinol,, Velban,, interleukin-2,, Intron-A,, Yervoy
Intervention Description
Bevacizumab 7.5mg/kg week 1,repeat weeks 4,7,10 (cycles 2, 3, & 4)
Primary Outcome Measure Information:
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)
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.
Time Frame
Primary Objective
Secondary Outcome Measure Information:
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)
Description
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.
Time Frame
Secondary Objective

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage 4 or unresectable stage 3 metastatic melanoma with or without measurable disease Age 18-70 years old Adequate pulmonary and cardiac function for high-dose IL-2 PS 0-2 Previous ipilimumab therapy will not exclude patients, but patients with previous ipilimumab will have separate efficacy analysis Exclusion Criteria: Brain metastases Creatinine > 2x ULN; bilirubin > 3, WBC < 3500, Platelets < 100,000, Hgb < 9 Another active malignancy Gastrointestinal tract metastases except rectal metastases or primary are allowable Previous therapy for metastatic disease with chemotherapy of duration over 3 months or with high-dose interleukin-2 History of colitis or autoimmune disease such as lupus or rheumatoid arthritis Bevacizumab-related contraindications: Hemoptysis or history of severe bleeding, uncontrolled hypertension, proteinuria with protein/creatinine ratio > 1, acute myocardial infarction within 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Minor, MD
Organizational Affiliation
California Pacific Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
result

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

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