Gene Therapy in Treating Patients With Cancer

R

Roger Williams Medical Center

Status and phase

Completed
Phase 1

Conditions

Cancer

Treatments

Biological: therapeutic autologous lymphocytes

Study type

Interventional

Funder types

Other

Identifiers

NCT00004178
NCI-V99-1577
BIDMC-941101148
NEDH-941101148
CDR0000067388

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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