Gene Therapy in Treating Patients With Non-Small Cell Lung Cancer That Cannot Be Surgically Removed
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Purpose
RATIONALE: Exposing tumor cells to the p53 gene may improve the body's ability to fight non-small cell lung cancer.
PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have non-small cell lung cancer that cannot be surgically removed.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: Ad5CMV-p53 gene |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Pilot Trial of Adenovirus p53 in Bronchioloalveolar Cell Lung Carcinoma (BAC) Administered by Bronchoalveolar Lavage |
| Study Start Date: | November 1998 |
OBJECTIVES:
- Evaluate the safety of multiple endobronchial treatments with adenovirus p53 bronchoalveolar lavage of a single lobe of the lung in patients with bronchoalveolar cell lung carcinoma.
- Evaluate expression of the p53 gene and induction of apoptosis in tumor and normal tissues exposed to the virus in these patients.
- Evaluate whether transbronchial administration of adenovirus p53 results in improved local tumor control in these patients.
OUTLINE: This is a dose escalation study.
Patients undergo biopsy and receive adenovirus p53 by bronchoalveolar lavage on days 1 and 15. Patients repeat biopsy on days 3 and 28. If there is evidence of clinical benefit or response without significant toxicity, patients may receive a maximum of 3 courses. Treatment beyond 3 courses must be approved by protocol investigator.
Cohorts of 3 patients are treated at escalating dose levels of adenovirus p53. Patients in each cohort are followed for dose limiting toxicity (DLT) for 2 weeks after completion of one course before dose escalation proceeds in subsequent cohorts. If 1 of 3 patients at a dose level experiences dose limiting toxicity (DLT), then 2 additional patients are entered at the same dose level. If more than 1 of 5 patients experience DLT, the previous dose is the maximum tolerated dose (MTD). An additional 10 patients are treated at the MTD.
Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and annually thereafter.
PROJECTED ACCRUAL: There will be 15 patients accrued into this study over 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed unresectable non-small cell lung cancer with a growth pattern allowing access to the majority of tumor cells via the airway (e.g., bronchioloalveolar or papillary adenocarcinoma)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- Prothrombin time and partial thromboplastin time normal
Hepatic:
- Bilirubin less than 1.5 mg/dL
Renal:
- Creatinine less than 1.5 mg/dL
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Pulmonary:
- Room air oxygen saturation greater than 90%
- FEV1 greater than 1.0 L pCO2 less than 50
Other:
- HIV negative
- No active systemic viral, bacterial, or fungal infections requiring treatment
- No concurrent illness requiring hospitalization or intravenous medication
- Not pregnant or nursing
- Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior adenovirus gene therapy
- At least 2 weeks since any systemic biologic therapy including prior biologic response modifiers and recovered
Chemotherapy:
- At least 2 weeks since any prior systemic chemotherapy and recovered
Endocrine therapy:
- Recovered from any prior endocrine therapy
Radiotherapy:
- Recovered from any prior radiotherapy
Surgery:
- At least 2 weeks since any surgical procedure requiring anesthesia
- At least 4 weeks since prior surgical resection of lung tissues
Other:
- No other concurrent therapy
Contacts and Locations| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Wisconsin | |
| CCOP - Green Bay | |
| Green Bay, Wisconsin, United States, 54301 | |
| Study Chair: | David P. Carbone, MD, PhD | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003649 History of Changes |
| Other Study ID Numbers: | CDR0000066741, E-6597 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer bronchoalveolar cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013