- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004178
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Richard P. Junghans, MD, PhD, Beth Israel Deaconess Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV renal cell cancer
- recurrent renal cell cancer
- recurrent non-small cell lung cancer
- extensive stage small cell lung cancer
- recurrent small cell lung 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
- recurrent salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- adenocarcinoma of the rectum
- stage IV rectal cancer
- stage IV colon cancer
- adenocarcinoma of the colon
- recurrent colon cancer
- recurrent rectal cancer
- recurrent pancreatic cancer
- adenocarcinoma of the pancreas
- adenocarcinoma of the lung
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- stage III colon cancer
- adenocarcinoma of the prostate
- stage IV pancreatic cancer
- stage IV gastric cancer
- recurrent gastric cancer
- advanced adult primary liver cancer
- recurrent adult primary liver cancer
- 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 renal cell cancer
- stage III cervical cancer
- stage IVA cervical cancer
- stage III gastric cancer
- stage II esophageal cancer
- stage III esophageal cancer
- adenocarcinoma of the stomach
- adenocarcinoma of the esophagus
- ovarian serous cystadenocarcinoma
- ovarian undifferentiated adenocarcinoma
- ovarian clear cell cystadenocarcinoma
- ovarian endometrioid adenocarcinoma
- ovarian mucinous cystadenocarcinoma
- salivary gland adenocarcinoma
- recurrent esophageal cancer
- recurrent cervical cancer
- stage IVB cervical cancer
- stage III rectal cancer
- cervical adenocarcinoma
- stage III pancreatic cancer
- stage III endometrial carcinoma
- recurrent vaginal cancer
- stage III vaginal cancer
- stage IVA vaginal cancer
- stage IVB vaginal cancer
- stage IV esophageal cancer
- localized unresectable adult primary liver cancer
- duct cell adenocarcinoma of the pancreas
- stage II pancreatic cancer
- adenocarcinoma of the bladder
- endometrial adenocarcinoma
- adenocarcinoma of unknown primary
- adenocarcinoma of the gallbladder
- adenocarcinoma of the extrahepatic bile duct
- adenocarcinoma with squamous metaplasia of the gallbladder
- mucinous adenocarcinoma of the colon
- diffuse adenocarcinoma of the stomach
- intestinal adenocarcinoma of the stomach
- mixed adenocarcinoma of the stomach
- signet ring adenocarcinoma of the colon
- mucinous adenocarcinoma of the rectum
- signet ring adenocarcinoma of the rectum
- vaginal adenocarcinoma
- vaginal clear cell adenocarcinoma
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067388
- BIDMC-941101148
- NEDH-941101148
- NCI-V99-1577
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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