NCT00027534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Jan 2002

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2001

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

5.8 years

First QC Date

December 7, 2001

Last Update Submit

September 4, 2014

Conditions

Breast CancerColorectal CancerGallbladder CancerGastric CancerHead and Neck CancerLiver CancerOvarian CancerPancreatic CancerTesticular Germ Cell Tumor

Keywords

recurrent colon cancerstage III colon cancerstage IV colon cancerrecurrent breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent gastric cancerstage III gastric cancerstage IV gastric cancerrecurrent pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent rectal cancerstage III rectal cancerstage IV rectal canceradvanced adult primary liver cancerrecurrent adult primary liver cancerrecurrent gallbladder cancerunresectable gallbladder cancerthyroid gland medullary carcinomarecurrent salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancerPaget disease of the breast with intraductal carcinomaPaget disease of the breast with invasive ductal carcinomaadult primary hepatocellular carcinomadiffuse adenocarcinoma of the stomachintestinal adenocarcinoma of the stomachmixed adenocarcinoma of the stomachadenocarcinoma of the colonadenocarcinoma of the gallbladderadenocarcinoma of the rectumrecurrent malignant testicular germ cell tumorstage II malignant testicular germ cell tumorstage III malignant testicular germ cell tumormale breast canceradenocarcinoma of the pancreascholangiocarcinoma of the gallbladdersalivary gland adenocarcinomaovarian endometrioid adenocarcinomastage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Immune response

    12-36 weeks

Study Arms (1)

TRICOM-CEA(6D)

EXPERIMENTAL

Subjects receiving TRICOM-CEA(6D)

Biological: TRICOM-CEA(6D)

Interventions

TRICOM-CEA(6D)BIOLOGICAL

dendritic cells loaded with TRICOM-CEA(6D)

Also known as: recombinant fowlpox-CEA(6D)/TRICOM vaccine
TRICOM-CEA(6D)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * Karnofsky 70-100% Life expectancy * More than 6 months Hematopoietic * 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 Renal * Creatinine less than 2.5 mg/dL * No active acute or chronic urinary tract infection Cardiovascular * 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 PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior biologic therapy and recovered * No other concurrent immunotherapy Chemotherapy * At least 4 weeks since prior chemotherapy and recovered * No concurrent chemotherapy Endocrine therapy * 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 Radiotherapy * 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 Surgery * Not specified Other * At least 4 weeks since any other prior therapy (including experimental therapy) and recovered * No concurrent immunosuppressives (e.g., azathioprine or cyclosporine)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsGallbladder NeoplasmsStomach NeoplasmsHead and Neck NeoplasmsLiver NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsTesticular Germ Cell TumorColonic NeoplasmsRectal NeoplasmsCarcinoma, HepatocellularCarcinoma, MedullarySalivary Gland NeoplasmsTesticular NeoplasmsBreast Neoplasms, Male

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesLiver DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve TissueMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular Diseases

Study Officials

  • Herbert K. Lyerly, MD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2001

First Posted

January 27, 2003

Study Start

January 1, 2002

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

September 8, 2014

Record last verified: 2014-09

Locations

US(1)