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Gene Therapy in Treating Patients With Cancer

This study is ongoing, but not recruiting participants.
Study NCT00004178.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Gene Therapy in Treating Patients With Cancer
Official Title  Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
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.

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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cancer
Intervention  Drug: therapeutic autologous lymphocytes
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  April 1998
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00004178
Organization ID CDR0000067388
Secondary IDs †† BIDMC-941101148, NEDH-941101148, NCI-V99-1577
Study Sponsor  Beth Israel Deaconess Medical Center
Collaborators ††
Investigators 
Study Chair:     Richard P. Junghans, MD, PhD     Beth Israel Deaconess Medical Center    
Information Provided By National Cancer Institute (NCI)
Verification Date May 2006
First Received Date  January 21, 2000
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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