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Gene Therapy in Treating Patients With Cancer

Primary Purpose

Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
therapeutic autologous lymphocytes
Sponsored by
Roger Williams Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 21, 2000
Last Updated
June 9, 2011
Sponsor
Roger Williams Medical Center
Collaborators
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00004178
Brief Title
Gene Therapy in Treating Patients With Cancer
Official Title
Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
December 2000 (Actual)
Study Completion Date
December 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roger Williams Medical Center
Collaborators
Beth Israel Deaconess Medical Center

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
therapeutic autologous lymphocytes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard P. Junghans, MD, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Gene Therapy in Treating Patients With Cancer

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