Vaccine Therapy In Treating Patients With Advanced Or Metastatic Cancer

Study Overview

Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer

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.

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.

Breast Cancer
Colorectal Cancer
Gallbladder Cancer
Gastric Cancer
Head and Neck Cancer
Liver Cancer
Ovarian Cancer
Pancreatic Cancer
Testicular Germ Cell Tumor

BIOLOGICAL: TRICOM-CEA(6D)

2840
1R21CA094523 (U.S. NIH Grant/Contract)
2840 (OTHER Identifier) (OTHER: Duke IRB)
CDR0000069041

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2001-12-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-09-04
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-09-08
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2014-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: TRICOM-CEA(6D) Subjects receiving TRICOM-CEA(6D)	BIOLOGICAL: TRICOM-CEA(6D) dendritic cells loaded with TRICOM-CEA(6D)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: TRICOM-CEA(6D)

Subjects receiving TRICOM-CEA(6D)

BIOLOGICAL: TRICOM-CEA(6D)

dendritic cells loaded with TRICOM-CEA(6D)

Primary Outcome Measures	Measure Description	Time Frame
Safety	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.	12-36 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Immune response	The immune response to the injections of the TRICOM-CEA(6D) antigen loaded DC will be evaluated	12-36 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed advanced or metastatic malignancy expressing CEA

Metastatic disease meeting one of the following criteria:

Measurable or nonmeasurable
History of metastases but no current evidence of disease, meeting one of the following criteria:

Unresectable peritoneal or lymph node metastases that cannot be detected by imaging
Treated or resected metastatic disease considered at high risk of recurrence (predicted 5-year disease-free survival of less than 50%)

Must have completed treatment that rendered no evidence of disease within the past year
CEA-expressing malignancy is defined by any of the following:

Immunohistochemical staining (at least 50% of the tumor has at least a moderate intensity of staining)
CEA level in peripheral blood greater than 2.5 µg/L
Tumor known to be universally CEA positive (e.g., colon and rectal cancer)
Received prior therapy with possible survival benefit or refused such therapy
Prior resection of brain metastases allowed provided no metastasis by CT scan or MRI of the brain within 1 month of enrollment
Hormone receptor status:

Not specified

18 and over Sex
Male or female Menopausal status
Not specified Performance status
Karnofsky 70-100% Life expectancy
More than 6 months

WBC at least 3,000/mm^3
Absolute lymphocyte count at least 1,000/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed) Hepatic
Bilirubin less than 2.0 mg/dL
SGOT/SGPT less than 1.5 times upper limit of normal
No active acute or chronic viral hepatitis
Hepatitis B surface antigen negative
Hepatitis C negative
No other hepatic disease that would preclude study entry

Creatinine less than 2.5 mg/dL
No active acute or chronic urinary tract infection

No New York Heart Association class III or IV heart disease Immunologic
HIV negative
No history of autoimmune disease, including, but not limited to, the following:

Inflammatory bowel disease
Systemic lupus erythematosus
Rheumatoid arthritis
Ankylosing spondylitis
Scleroderma
Multiple sclerosis
No allergy to eggs or any component of study vaccine Other
No active acute or chronic infection
No concurrent serious acute or chronic illness that would preclude study entry
No other medical or psychological impediment that would preclude study entry
No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

At least 4 weeks since prior biologic therapy and recovered
No other concurrent immunotherapy

At least 4 weeks since prior chemotherapy and recovered
No concurrent chemotherapy

At least 4 weeks since prior hormonal therapy and recovered
At least 6 weeks since prior steroids except steroids used as premedication for chemotherapy or for contrast-enhanced studies
No concurrent steroids

Prior palliative radiotherapy (including systemic radiolabeled compounds) for unstable or painful bone metastases in weight-bearing bones may be allowed
At least 4 weeks since prior radiotherapy and recovered
No concurrent radiotherapy

Not specified

At least 4 weeks since any other prior therapy (including experimental therapy) and recovered
No concurrent immunosuppressives (e.g., azathioprine or cyclosporine)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Herbert K. Lyerly, MD, Duke Cancer Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record