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

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 plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI).

Study Overview

• Status: Completed
• Conditions: Metastatic Melanoma
• Intervention / Treatment: Drug: Biochemo + bevacizumab then ipilimumab

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)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • San Francisco Oncology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Other Names: Yervoy; Platinol,; Avastin,; Temodar,; Velban,; interleukin-2,; Intron-A,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: California Pacific Medical Center Research Institute
• Investigators: Principal Investigator: David R Minor, MD, California Pacific Medical Center

Publications and helpful links

General Publications

• 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)

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): August 29, 2013
• Last Update Submitted That Met QC Criteria: August 28, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Immune Checkpoint Inhibitors; Bevacizumab; Ipilimumab; Interleukin-2
• Other Study ID Numbers: BBI Total Therapy