Clinical trial · Interventional
Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Phase I Pilot Trial of Adenovirus p53 and Radiotherapy on Nonsmall Cell Lung Cancer
NCT00004225CI-TRIAL-00003640completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Inserting the gene for p53 into a person's cancer cells may improve the body's ability to fight cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I trial to study the effectiveness of gene therapy plus radiation therapy in treating patients who have non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ad5CMV-p53 gene | Biological | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven non-small cell lung cancer with at least 1 lesion accessible for endobronchial or percutaneous injection * Measurable or evaluable disease * Must have a requirement for palliative radiotherapy to the thorax * Clinically stable enough to undergo 3 adenovirus injections PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0 or 1 Life expectancy: * At least 12 weeks Hematopoietic: * Platelet count greater than 100,000/mm\^3 Hepatic: * PT and PTT normal Renal: * Not specified Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * No active systemic viral, bacterial, or fungal infection requiring treatment * No concurrent illness requiring hospitalization or IV medications or psychologic, familial, sociologic, geographic, or other concurrent condition that would preclude adequate follow up and compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior adenoviral gene therapy * Any number of any type of other prior biologic therapy allowed Chemotherapy: * Any number of any type of prior chemotherapy allowed * At least 2 weeks since prior systemic cancer therapy and no worse than grade 2 toxicity in any organ Endocrine therapy: * Any number of any type of prior endocrine therapy allowed Radiotherapy: * See Disease Characteristics * No prior radiotherapy greater than 50 Gy if prior and concurrent radiation fields include the spinal cord * No prior radiotherapy in fraction sizes greater than 2 Gy with the spinal cord in the concurrent radiation field Surgery: * At least 4 weeks since surgical resection of lung tissue * At least 2 weeks since any other prior surgery requiring general anesthesia and recovered
References
Publications (0)
Data not yet available
No reference posted for this study.