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Home > "G" Clinical Trials Conditions > Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed  Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed
Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed
For Condition: bronchoalveolar cell lung cancer,stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer,recurrent non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Evaluate expression of the p53 gene and induction of apoptosis in tumor and normal tissues exposed to the virus in these patients. III. Evaluate whether transbronchial administration of adenovirus p53 results in improved local tumor control in these patients. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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) --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 --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: - Platelet count greater than 100,000/mm3 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidCarbone, Study Chair, Eastern Cooperative Oncology Group
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212
United States
CCOP - Green Bay
Green Bay, Wisconsin, 54301
United States
Additional Information:
Study ID Numbers: CDR0000066741; E-6597
Study Start Date: November 1998
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003649
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
2. 10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
3. Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer
4. Gemcitabine, Carboplatin, and Bortezomib in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
5. Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other Tennessee Clinical Trials
Other Nashville Clinical Trials
Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed
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