NCT00003434

Brief Summary

Rational: White blood cells that have been treated with carcinoembryonic antigen peptide-1 may help the body build an immune response to and kill tumor cells that express CEA. Purpose: Phase II trial to study the effectiveness of white blood cells plus carcinoembryonic antigen peptide-1 in treating patients with stage I, stage II, or stage III pancreatic cancer that has been surgically removed.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1 pancreatic-cancer

Timeline
Completed

Started Jun 1998

Typical duration for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

April 27, 2004

Completed
Last Updated

February 10, 2014

Status Verified

February 1, 2014

Enrollment Period

4.2 years

First QC Date

November 1, 1999

Last Update Submit

February 7, 2014

Conditions

Pancreatic Cancer

Keywords

stage I pancreatic cancerstage II pancreatic cancerstage III pancreatic canceradenocarcinoma of the pancreas

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

Interventions

carcinoembryonic antigen peptide 1BIOLOGICAL
hepatitis B antigen peptideBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Disease Characteristics: * Histologically confirmed stage I, II, or III adenocarcinoma of the pancreas Resected with no gross residual disease At least 50% of tumor cells must be CEA positive and stain with at least moderate intensity HLA-A2 positive Patient Characteristics: * Age: 18 and over * Performance status: Karnofsky 70-100% * Life expectancy: Greater than 6 months * Hematopoietic: Absolute neutrophil count at least 1000/mm3 * Hepatic: Bilirubin less than 2.0 mg/dL SGOT and alkaline phosphatase less than 4 times the upper limit of normal No hepatic failure * Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min * Cardiovascular: No New York Heart Association class III or IV heart disease * Pulmonary: No concurrent asthma or chronic obstructive pulmonary disease Other: * No other malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer within the past 5 years. * No history of autoimmune diseases such as inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, rheumatoid arthritis, or multiple sclerosis * No active acute or chronic infection such as urinary tract infection, HIV, or viral hepatitis * No active infectious enteritis or eosinophilic enteritis Not pregnant or nursing Fertile patients must use effective contraception Prior Therapy: * Biologic therapy: At least 4 weeks since immunotherapy. No other concurrent immunotherapy * Chemotherapy: At least 4 weeks since chemotherapy and recovered. No concurrent chemotherapy * Endocrine therapy: No concurrent corticosteroid or immunosuppressive therapy. At least 6 weeks since steroid therapy * Radiotherapy: At least 4 weeks since radiotherapy and recovered * Surgery: Recovered from prior surgery

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

Pancreatic Neoplasms

Interventions

CAP1-6DHepatitis B Surface Antigens

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Hepatitis B AntigensHepatitis AntigensAntigens, ViralViral ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Officials

  • Michael A. Morse, MD

    Duke University

    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

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 27, 2004

Study Start

June 1, 1998

Primary Completion

August 1, 2002

Study Completion

August 1, 2002

Last Updated

February 10, 2014

Record last verified: 2014-02

Locations

US(1)