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

NCT01743157 | Completed Phase 1 DMC

• 1 other identifier: BBI Total Therapy
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy and Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)

  Secondary Objective

Study Arms (1)

Biochemo + Bevacizumab then Ipilimumab

EXPERIMENTAL

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

Interventions

Biochemo + bevacizumab then ipilimumab DRUG

Bevacizumab 7.5mg/kg week 1,repeat weeks 4,7,10 (cycles 2, 3, \& 4)

Also known as: Avastin,, Temodar,, Platinol,, Velban,, interleukin-2,, Intron-A,, Yervoy

Biochemo + Bevacizumab then Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• California Pacific Medical Center Research Institute: lead

Study Sites (1)

San Francisco Oncology Associates

San Francisco, California, 94115, United States

Location

Related Publications (1)

• 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)

  RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Bevacizumab; Temozolomide; Cisplatin; Vinblastine; Interleukin-2; Introns; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Lymphokines; Biological Factors; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• David R Minor, MD

  California Pacific Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: December 6, 2012
• Study Start: December 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

US (1)