Gene Therapy in Treating Patients With Cancer

Cancer Clinical Trial

Official title:

Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004178
• Other study ID #: CDR0000067388
• Secondary ID: BIDMC-941101148N
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2000
• Last updated: June 9, 2011
• Start date: April 1998
• Est. completion date: December 2001

Study information

• Verified date: May 2006
• Source: Roger Williams Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2001
• Est. primary completion date: December 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Biological:
• therapeutic autologous lymphocytes

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Roger Williams Medical Center	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States,