NCT00004178

Brief Summary

RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have cancer that has not responded to previous therapy.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1998

Typical duration for phase_1 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

April 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2000

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2000

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

April 19, 2004

Completed
Last Updated

June 10, 2011

Status Verified

May 1, 2006

Enrollment Period

2.7 years

First QC Date

January 21, 2000

Last Update Submit

June 9, 2011

Conditions

Cancer

Keywords

stage III colon cancerstage IV colon cancerstage III gastric cancerstage IV gastric cancerrecurrent gastric cancerrecurrent non-small cell lung cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancerstage III rectal cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerstage II esophageal cancerstage III esophageal cancerstage IV esophageal cancerrecurrent esophageal cancerstage III cervical cancerrecurrent cervical cancerstage IVB cervical cancerstage IVA cervical canceradenocarcinoma of the prostatestage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial canceradenocarcinoma of the stomachextensive stage small cell lung cancerrecurrent small cell lung cancerstage III vaginal cancerstage IVA vaginal cancerstage IVB vaginal cancerrecurrent vaginal cancerlocalized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver cancerstage III endometrial carcinomastage IV endometrial carcinomarecurrent endometrial carcinomasmall intestine adenocarcinomaunresectable gallbladder cancerrecurrent gallbladder cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine cancerstage III bladder cancerrecurrent bladder cancerstage IV bladder cancerstage III prostate cancerstage IV prostate cancerrecurrent prostate cancerstage IV non-small cell lung cancerstage III salivary gland cancerstage IV salivary gland cancerrecurrent salivary gland cancerduct cell adenocarcinoma of the pancreasovarian undifferentiated adenocarcinomaadenocarcinoma of the lungadenocarcinoma of the esophagusintestinal adenocarcinoma of the stomachadenocarcinoma of the colondiffuse adenocarcinoma of the stomachmixed adenocarcinoma of the stomachmucinous adenocarcinoma of the colonsignet ring adenocarcinoma of the colonadenocarcinoma of the rectumadenocarcinoma of the gallbladdermucinous adenocarcinoma of the rectumsignet ring adenocarcinoma of the rectumadenocarcinoma with squamous metaplasia of the gallbladderadenocarcinoma of the extrahepatic bile ductovarian serous cystadenocarcinomaovarian mucinous cystadenocarcinomaovarian endometrioid adenocarcinomaovarian clear cell cystadenocarcinomavaginal adenocarcinomavaginal clear cell adenocarcinomaendometrial adenocarcinomacervical adenocarcinomaadenocarcinoma of the bladdersalivary gland adenocarcinomaadenocarcinoma of unknown primaryadenocarcinoma of the pancreasstage IV pancreatic cancer

Interventions

therapeutic autologous lymphocytesBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven CEA expressing adenocarcinoma * Serum CEA levels greater than 10 ng/mL * Failed standard therapy * Measurable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * 0-2 Life expectancy: * Greater than 2 months Hematopoietic: * Not specified Hepatic: * No significant hepatic disease * Bilirubin no greater than 3 mg/dL * No active clinical disease caused by hepatitis B Renal: * No significant renal disease * Creatinine no greater than 3 mg/dL Cardiovascular: * No significant cardiovascular disease Pulmonary: * No significant pulmonary disease Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No significant endocrine, rheumatologic, or allergic disease * No active clinical disease caused by cytomegalovirus or tuberculosis * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

NeoplasmsColonic NeoplasmsStomach NeoplasmsCarcinoma, Non-Small-Cell LungPancreatic NeoplasmsRectal NeoplasmsEsophageal NeoplasmsUterine Cervical NeoplasmsCarcinoma, Renal CellCarcinoma, Ovarian EpithelialSmall Cell Lung CarcinomaVaginal NeoplasmsCarcinoma, HepatocellularEndometrial NeoplasmsGallbladder NeoplasmsBile Duct NeoplasmsUrinary Bladder NeoplasmsProstatic NeoplasmsSalivary Gland NeoplasmsAdenocarcinoma of LungAdenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesStomach DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesRectal DiseasesHead and Neck NeoplasmsEsophageal DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsKidney DiseasesUrologic DiseasesMale Urogenital DiseasesOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGonadal DisordersVaginal DiseasesLiver NeoplasmsLiver DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesBile Duct DiseasesUrinary Bladder DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Study Officials

  • Richard P. Junghans, MD, PhD

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2000

First Posted

April 19, 2004

Study Start

April 1, 1998

Primary Completion

December 1, 2000

Study Completion

December 1, 2001

Last Updated

June 10, 2011

Record last verified: 2006-05

Locations

US(1)