Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors

Summary

This pilot phase Ib trial studies the side effects and best dose of recombinant EphB4-HSA fusion protein when given together with standard chemotherapy regimens in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic). Drugs used in chemotherapy, such as recombinant EphB4-HSA fusion protein, paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, docetaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether standard chemotherapy regimens are more effective with recombinant ephB4-HSA fusion protein in treating advanced or metastatic solid tumors.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Metastatic Pancreatic Adenocarcinoma
• Non-Resectable Cholangiocarcinoma
• Pancreatic Adenocarcinoma
• Recurrent Gallbladder Carcinoma
• Recurrent Non-Small Cell Lung Carcinoma
• Stage III Pancreatic Cancer
• Stage IIIA Gallbladder Cancer
• Stage IIIA Non-Small Cell Lung Cancer
• Stage IIIB Gallbladder Cancer
• Stage IIIB Non-Small Cell Lung Cancer
• Stage IV Gallbladder Cancer
• Stage IV Non-Small Cell Lung Cancer
• Stage IV Pancreatic Cancer
• Unresectable Gallbladder Carcinoma
• Unresectable Pancreatic Cancer

Interventions

DRUG

Cisplatin

Given IV

DRUG

Docetaxel

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Given IV

OTHER

Pharmacological Study

Correlative studies

BIOLOGICAL

Recombinant EphB4-HSA Fusion Protein

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Vasgene Therapeutics, Inc

  collaborator INDUSTRY

• University of Southern California

  lead OTHER

Principal Investigators

• Anthony El-Khoueiry · University of Southern California

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-03

Primary Completion

2021-04-01

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations