NCT00004604

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic cancer that has not responded to previous treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Feb 1997

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

Study Start

First participant enrolled

February 1, 1997

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

April 28, 2004

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

4.3 years

First QC Date

May 2, 2000

Last Update Submit

February 21, 2013

Conditions

Breast CancerColorectal CancerExtrahepatic Bile Duct CancerGallbladder CancerGastric CancerHead and Neck CancerLiver CancerLung CancerMetastatic CancerOvarian CancerPancreatic CancerTesticular Germ Cell Tumor

Keywords

stage IV colon cancerstage IV breast cancerrecurrent breast cancerstage IV gastric cancerrecurrent gastric cancerrecurrent non-small cell lung cancerrecurrent pancreatic cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerinflammatory breast cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerextensive stage small cell lung cancerrecurrent small cell lung cancerunresectable gallbladder cancerrecurrent gallbladder cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerstage III malignant testicular germ cell tumorrecurrent malignant testicular germ cell tumorthyroid gland medullary carcinomastage IV non-small cell lung cancerstage IV salivary gland cancerrecurrent salivary gland cancerPaget disease of the breast with invasive ductal carcinomaadult primary hepatocellular carcinomatesticular yolk sac tumorlung metastasesliver metastasescholangiocarcinoma of the gallbladdercholangiocarcinoma of the extrahepatic bile ductmale breast cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Safety

    To determine the safety and dose limiting toxicity of intravenous injections of autologous, cultured, dendritic cells pulsed with CEA RNA.

    12 months

Secondary Outcomes (1)

  • Immune response

    12 weeks

Study Arms (1)

CEA RNA-pulsed DC cancer vaccine

EXPERIMENTAL

carcinoembryonic antigen RNA-pulsed dendritic cells

Biological: CEA RNA-pulsed DC cancer vaccine

Interventions

CEA RNA-pulsed DC cancer vaccineBIOLOGICAL

carcinoembryonic antigen RNA-pulsed dendritic cells

CEA RNA-pulsed DC cancer vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma expressing carcinoembryonic antigen (CEA) that has failed conventional therapy Measurable or evaluable disease May include elevated CEA level No previously irradiated or known new CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 6 months Hematopoietic: WBC at least 3,000/mm3 Absolute lymphocyte count at least 1,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 PT less than 1.25 times normal limit PTT less that 1.66 times normal limit Fibrinogen greater than 0.75 times normal limit Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.5 mg/dL Cardiovascular: No NYHA class III or IV Pulmonary: FEV1 greater than 70% of predicted FVC greater than 70% of predicted DLCO greater than 70% of predicted No asthma or chronic obstructive pulmonary disease Other: No active or chronic infection (including urinary tract infection) No viral hepatitis HIV negative No concurrent second malignancy other than nonmelanoma skin cancer or controlled superficial bladder cancer No hepatic disease No history of other autoimmune disease such as inflammatory bowel disease, systemic lupus erythematous, ankylosing spondylitis, scleroderma, or multiple sclerosis PRIOR CONCURRENT THERAPY: Must have recovered from all acute toxic effects Biologic therapy: No concurrent biologic therapy At least 6 weeks since biologic therapy No concurrent immunotherapy No more than 1 prior biologic regimen Chemotherapy: No concurrent chemotherapy At least 6 weeks since chemotherapy No more than 1 prior chemotherapy regimen Endocrine therapy: At least 6 weeks since steroid therapy Radiotherapy: No concurrent radiotherapy At least 12 weeks since therapy including Sr 89 At least 6 weeks since other radiotherapy No prior cranial radiotherapy Surgery: Not specified Other: No concurrent immunosuppressives such as 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, 27710, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsBile Duct NeoplasmsGallbladder NeoplasmsStomach NeoplasmsHead and Neck NeoplasmsLiver NeoplasmsLung NeoplasmsNeoplasm MetastasisOvarian NeoplasmsPancreatic NeoplasmsTesticular Germ Cell TumorColonic NeoplasmsCarcinoma, Non-Small-Cell LungRectal NeoplasmsInflammatory Breast NeoplasmsCarcinoma, Ovarian EpithelialSmall Cell Lung CarcinomaTesticular NeoplasmsCarcinoma, MedullarySalivary Gland NeoplasmsCarcinoma, HepatocellularEndodermal Sinus TumorBreast 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 NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesLiver DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular DiseasesCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalAdenocarcinomaNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve TissueMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesMesonephroma

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2000

First Posted

April 28, 2004

Study Start

February 1, 1997

Primary Completion

June 1, 2001

Study Completion

July 1, 2002

Last Updated

February 22, 2013

Record last verified: 2013-02

Locations

US(1)