Gene Therapy in Treating Patients With Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
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Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients.
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Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR.
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Assess immunologic parameters which correlate with the efficacy of this regimen in these patients.
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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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically proven CEA expressing adenocarcinoma
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Serum CEA levels greater than 10 ng/mL
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Failed standard therapy
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000067388
- BIDMC-941101148
- NEDH-941101148
- NCI-V99-1577