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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard P. Junghans, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000067388

NCT ID:

NCT00004178

Start Date:

April 1998

Completion Date:

December 2001

Related Keywords:

  • Cancer
  • 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
  • stage IVA cervical cancer
  • adenocarcinoma of the prostate
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • adenocarcinoma of the stomach
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • stage III vaginal cancer
  • stage IVA vaginal cancer
  • stage IVB vaginal cancer
  • recurrent vaginal cancer
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • small intestine adenocarcinoma
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • recurrent small intestine cancer
  • stage III bladder cancer
  • recurrent bladder cancer
  • stage IV bladder cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • stage IV non-small cell lung cancer
  • stage III salivary gland cancer
  • stage IV salivary gland cancer
  • recurrent salivary gland cancer
  • duct cell adenocarcinoma of the pancreas
  • ovarian undifferentiated adenocarcinoma
  • adenocarcinoma of the lung
  • adenocarcinoma of the esophagus
  • intestinal adenocarcinoma of the stomach
  • adenocarcinoma of the colon
  • diffuse adenocarcinoma of the stomach
  • mixed adenocarcinoma of the stomach
  • mucinous adenocarcinoma of the colon
  • signet ring adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • adenocarcinoma of the gallbladder
  • mucinous adenocarcinoma of the rectum
  • signet ring adenocarcinoma of the rectum
  • adenocarcinoma with squamous metaplasia of the gallbladder
  • adenocarcinoma of the extrahepatic bile duct
  • ovarian serous cystadenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • vaginal adenocarcinoma
  • vaginal clear cell adenocarcinoma
  • endometrial adenocarcinoma
  • cervical adenocarcinoma
  • adenocarcinoma of the bladder
  • salivary gland adenocarcinoma
  • adenocarcinoma of unknown primary
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215