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Gene Therapy in Treating Patients With Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Beth Israel Deaconess Medical Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004178
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: therapeutic autologous lymphocytes
Phase I

Genetics Home Reference related topics:   Benign Tumors   Cancer  

MedlinePlus related topics:   Cancer   Cervical Cancer   Esophageal Cancer   Esophagus Disorders   Lung Cancer   Pancreatic Cancer   Salivary Gland Disorders   Vaginal Cancer  

ChemIDplus related topics:   Globulin, Immune   Immunoglobulins   Pancrelipase   Ultrase  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   April 1998

Detailed Description:

OBJECTIVES:

  • Determine the safety and maximum tolerated dose of T cells activated in vitro and modified with chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR) in patients with CEA expressing adenocarcinoma.
  • Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients.
  • Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR.
  • Assess immunologic parameters which correlate with the efficacy of this regimen in these patients.
  • Evaluate, in a preliminary manner, the efficacy of this regimen in patients with CEA bearing tumors.

OUTLINE: This is a dose escalation study.

Peripheral blood lymphocytes (PBL) are harvested. PBL are activated in vitro and then modified with recombinant chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR). Ig TCR modified T cells are reinfused over 30-60 minutes.

The estimated maximum tolerated dose (MTD) is defined as the dose at which 2 of 6 patients experience unacceptable toxicity. If the MTD is not reached within the first cohort, a second cohort of 3 patients then receives 4 doses of modified T cells at a higher dose.

Patients are followed every 2 weeks for 2 months.

PROJECTED ACCRUAL: A total of 6-9 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004178

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center    
      Boston, Massachusetts, United States, 02215

Sponsors and Collaborators
Beth Israel Deaconess Medical Center

Investigators
Study Chair:     Richard P. Junghans, MD, PhD     Beth Israel Deaconess Medical Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067388, BIDMC-941101148, NEDH-941101148, NCI-V99-1577
First Received:   January 21, 2000
Last Updated:   June 28, 2008
ClinicalTrials.gov Identifier:   NCT00004178
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer  
stage IV colon cancer  
stage III gastric cancer  
stage IV gastric cancer  
recurrent gastric cancer  
recurrent non-small cell lung cancer  
stage II pancreatic cancer  
stage III pancreatic cancer  
recurrent pancreatic cancer  
stage III rectal cancer  
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer
stage III cervical cancer
recurrent cervical cancer
stage IVB cervical cancer

Study placed in the following topic categories:
Cystadenocarcinoma, Serous
Pancreatic Neoplasms
Esophageal Neoplasms
Liver neoplasms
Kidney cancer
Ovarian epithelial cancer
Pancrelipase
Liver Neoplasms
Uterine Cervical Neoplasms
Adenocarcinoma of lung
Adenocarcinoma, Clear Cell
Lung Neoplasms
Stomach Neoplasms
Metaplasia
Endometrial cancer
Rectal cancer
Salivary Gland Diseases
Esophageal neoplasm
Immunoglobulins
Bladder neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 03, 2008




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