A Phase 1 interventional study of Ad5CMV-p53 gene in Lung Cancer, sponsored by Eastern Cooperative Oncology Group. Completed at 3 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Eastern Cooperative Oncology Group · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
Browse Lung Neoplasms studies →Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Eastern Cooperative Oncology Group