NCT00012246

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of two different vaccines in treating patients who have cancer of the gastrointestinal tract.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started Jul 2002

Typical duration for phase_2 colorectal-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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2001

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

Enrollment Period

4 years

First QC Date

March 3, 2001

Last Update Submit

May 15, 2013

Conditions

Colorectal CancerEsophageal CancerExtrahepatic Bile Duct CancerGallbladder CancerGastric CancerPancreatic CancerSmall Intestine Cancer

Keywords

stage II colon cancerstage III colon cancerstage IV colon cancerstage II gastric cancerstage III gastric cancerstage IV gastric cancerrecurrent gastric cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancerstage II rectal cancerstage III rectal cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerstage II esophageal cancerstage III esophageal cancerstage IV esophageal cancerrecurrent esophageal canceradenocarcinoma of the stomachsmall intestine adenocarcinomalocalized gallbladder cancerunresectable gallbladder cancerrecurrent gallbladder cancerlocalized extrahepatic bile duct cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine canceradenocarcinoma of the esophagusadenocarcinoma of the colonadenocarcinoma of the rectumadenocarcinoma of the gallbladderadenocarcinoma of the extrahepatic bile ductadenocarcinoma of the pancreasstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (4)

  • Production of CAP 1-6D T cells

  • Production of cytotoxic T cells

  • Antitumor response

  • Frequency and severity of toxic effects

Interventions

carcinoembryonic antigen peptide 1-6DBIOLOGICAL
incomplete Freund's adjuvantBIOLOGICAL
sargramostimBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed stage II, III, or IV adenocarcinoma of the gastrointestinal tract originating in 1 of the following: * Esophagus * Stomach * Pancreas * Small intestine * Colon or rectum * Gall bladder * Extrahepatic bile ducts * Ampulla of Vater * Completed standard therapy and at risk of recurrent disease OR has relatively stable metastatic disease and a life expectancy of at least 6 months * Carcinoembryonic antigen (CEA)-producing tumor as evidenced by detectable blood levels of CEA or positive for CEA on immunohistochemical staining * Human Leukocyte Antigen (HLA)-A2+ PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Southwest Oncology Group (SWOG) 0-1 Life expectancy: * See Disease Characteristics Hematopoietic: * White Blood Count (WBC) at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8 g/dL Hepatic: * Serum Glutamic Oxalacetic Transaminase (SGOT) or Serum Glutamic Pyruvic Transaminase (SGPT) no greater than 3 times upper limit of normal * Hepatitis B and C negative Renal: * Creatinine no greater than 2.0 mg/dL Other: * No other prior malignancy unless currently disease free and off all therapy for that malignancy * Early skin cancer allowed * No AIDS * HIV negative * Not pregnant or nursing * Fertile patients must use effective contraception during and for 30 days after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * At least 4 weeks since prior surgery Other: * No other concurrent therapy for malignancy

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

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsEsophageal NeoplasmsBile Duct NeoplasmsGallbladder NeoplasmsStomach NeoplasmsPancreatic NeoplasmsColonic NeoplasmsRectal NeoplasmsAdenocarcinoma Of Esophagus

Interventions

incomplete Freund's adjuvantsargramostim

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesHead and Neck NeoplasmsEsophageal DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Robert P. Whitehead, MD

    University of Texas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2001

First Posted

January 27, 2003

Study Start

July 1, 2002

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

May 16, 2013

Record last verified: 2013-05

Locations

US(1)