Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA

Phase 1

Completed

• Conditions: Colon Cancer; Lung Cancer; Breast Cancer
• Interventions: Biological: AD5 CEA Vaccine

• Registration Number: NCT01147965
• Lead Sponsor: Etubics Corporation

Brief Summary

The purpose of this study is to find out what effects (good and bad) that a cancer vaccine has on you and your cancer. The cancer vaccine is called Ad5 \[E1-, E2b-\]-CEA(6D)or ETBX-011 and is made by Etubics. This vaccine is based on a virus called an adenovirus but it has been changed to express the protein CEA that is found on some cancer cells. Therefore, the vaccine can tell the immune system to attack cancer cells which make CEA. The investigators are trying to determine whether giving this virus is safe and whether this causes a strong immune system attack on the cancer. ETBX-011 is an investigational drug.

Detailed Description

This is a phase I/II study with the primary purpose to determine the safety of immunization with Ad5 \[E1-, E2B-\]-CEA(6D), in patients with advanced or metastatic CEA-expressing malignancies. The secondary objectives are to evaluate CEA-specific immune responses to the immunizations and to obtain preliminary data on clinical response rate. The study population consists of patients with a histologically confirmed diagnosis of metastatic malignancy that is CEA positive who were previously treated with standard therapy known to have a possible survival benefit or refused such therapy. The study will determine the safety of three dosage levels of Ad5 \[E1-, E2B-\]-CEA(6D) vaccine (phase I component), and the maximally tolerated dose of Ad5 \[E1-, E2B-\]-CEA(6D) vaccine (phase II component). The study drug is Ad5 \[E1-, E2B-\]-CEA(6D) given by subcutaneous (SQ) injection every 3 weeks for 3 immunizations. We will evaluate safety in each cohort at least 3 weeks after the last patient in the previous cohort has received their first injection. A dosing scheme will be considered safe if \<33% of patients treated at a dosage level experience DLT (e.g., 0 of 3, ≤1 of 6, ≤3 of 12 or ≤5 of 18 patients).

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-15
• Study First Submitted QC: 2010-06-18
• Study First Posted: 2010-06-22
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ad5 CEA Vaccine	AD5 CEA Vaccine	Single arm dose escalation study

Primary Outcome Measures

Name	Time	Method
The primary objective of this protocol is to determine the safety of immunization with Ad5 [E1-, E2B-]-CEA(6D), in patients with advanced or metastatic CEA-expressing malignancies, including Maximum Tolerated Dose (MTD).	1 Year

Secondary Outcome Measures

Name	Time	Method
The secondary objectives of this protocol are to evaluate CEA-specific immune responses to the immunizations and to obtain preliminary data on clinical response rate.	1 Year

Trial Locations

Locations (2)

Duke Cancer Research Institute, Duke University; 🇺🇸 Durham, North Carolina, United States

Medical Oncology Associates, PS; 🇺🇸 Spokane, Washington, United States