Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer

Phase 1

Completed

• Conditions: Liver Cancer; Breast Cancer; Gallbladder Cancer; Colorectal Cancer; Head and Neck Cancer; Gastric Cancer; Pancreatic Cancer; Ovarian Cancer; Testicular Germ Cell Tumor
• Interventions: Biological: TRICOM-CEA(6D)

• Registration Number: NCT00027534
• Lead Sponsor: Michael Morse, MD

Brief Summary

RATIONALE: Vaccines made from a person's white blood cells that have been treated in the laboratory may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer.

Detailed Description

OBJECTIVES:

* Determine the safety and feasibility of active immunotherapy comprising autologous dendritic cells infected with recombinant fowlpox-CEA-TRICOM vaccine in patients with advanced or metastatic malignancies expressing CEA.

* Assess the CEA-specific immune response of patients treated with this regimen.

* Assess, in a preliminary manner, the clinical response rate of patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Autologous dendritic cells (ADCs) are harvested and infected with fowlpox-CEA-TRICOM vaccine. Patients receive the infected ADCs intradermally and subcutaneously (SC) followed by ADCs mixed with CMV pp65 peptide and ADCs mixed with tetanus toxoid SC and intradermally on day 1. Treatment repeats every 3 weeks for a total of 4, 8, or 12 immunizations in the absence of unacceptable toxicity.

Cohorts of 6 patients receive an escalating number of immunizations until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.

Study Timeline

• Study First Submitted: 2001-12-07
• Study Start: 2002-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRICOM-CEA(6D)	TRICOM-CEA(6D)	Subjects receiving TRICOM-CEA(6D)

Primary Outcome Measures

Name	Time	Method
Safety	12-36 weeks	The primary objective of this protocol is to determine the safety and feasibility of rF-CEA(6D)-TRICOM loaded DC in, subjects with metastatic, CEA expressing malignancies.

Secondary Outcome Measures

Name	Time	Method
Immune response	12-36 weeks	The immune response to the injections of the TRICOM-CEA(6D) antigen loaded DC will be evaluated

Trial Locations

Locations (1)

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States