Gene Therapy in Treating Patients With Cancer

This study has been completed.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by:
Roger Williams Medical Center
ClinicalTrials.gov Identifier:
NCT00004178
First received: January 21, 2000
Last updated: June 9, 2011
Last verified: May 2006

January 21, 2000
June 9, 2011
April 1998
December 2000   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004178 on ClinicalTrials.gov Archive Site
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Gene Therapy in Treating Patients With Cancer
Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
Cancer
Biological: therapeutic autologous lymphocytes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
December 2001
December 2000   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004178
CDR0000067388, BIDMC-941101148, NEDH-941101148, NCI-V99-1577
Not Provided
Richard Junghans, Roger Williams Medical Center
Roger Williams Medical Center
Beth Israel Deaconess Medical Center
Study Chair: Richard P. Junghans, MD, PhD Beth Israel Deaconess Medical Center
Roger Williams Medical Center
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP