Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
18 Years
N/A
Both
Cancer
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 Center | Boston, Massachusetts 02215 |
