Gene Therapy in Treating Patients With Cancer - Full Text View

Sponsor:	Roger Williams Medical Center
Collaborator:	Beth Israel Deaconess Medical Center
Information provided by:	Roger Williams Medical Center
ClinicalTrials.gov Identifier:	NCT00004178

Purpose

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.

Condition	Intervention	Phase
Cancer	Biological: therapeutic autologous lymphocytes	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer Help Me Understand Genetics

MedlinePlus related topics: Bladder Cancer Cancer Cervical Cancer Esophageal Cancer Esophagus Disorders Liver Cancer Lung Cancer Pancreatic Cancer Prostate Cancer Stomach Cancer Vaginal Cancer

U.S. FDA Resources

Further study details as provided by Roger Williams Medical Center:

Study Start Date:	April 1998
Study Completion Date:	December 2001
Primary Completion Date:	December 2000 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004178

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Roger Williams Medical Center

Beth Israel Deaconess Medical Center

Investigators

Study Chair:

Richard P. Junghans, MD, PhD

Beth Israel Deaconess Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Richard Junghans, Roger Williams Medical Center
ClinicalTrials.gov Identifier:	NCT00004178 History of Changes
Other Study ID Numbers:	CDR0000067388, BIDMC-941101148, NEDH-941101148, NCI-V99-1577
Study First Received:	January 21, 2000
Last Updated:	June 9, 2011
Health Authority:	United States: Federal Government

Keywords provided by Roger Williams Medical Center:

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

Additional relevant MeSH terms:

Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012