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Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical research trials and Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer. Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer  Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
For Condition: recurrent non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - Determine the feasibility and tolerability of adenovirus p53 gene therapy and radiotherapy in patients with non-small cell lung cancer with or without prior radiotherapy to the indicator lesion(s). - Determine p53 and p21 expression and induction of apoptosis and necrosis in patients treated with this regimen. - Assess any vector incorporation, antitumor response, local control, viral dissemination, and development of adenovirus antibodies in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified by prior radiotherapy to the indicator lesion(s) (yes vs no). Adenovirus p53 is injected directly into an endobronchial lesion via bronchoscopy or into locoregional tumors via multiple percutaneous punctures under fluoroscopic, ultrasonic, or CT scan guidance on days 1, 3, and 8. Patients undergo radiotherapy beginning on day 2 and continuing for a total of 10 days. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoanSchiller, Study Chair, University of Wisconsin Comprehensive Cancer Center
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-6838
United States
Additional Information:
Study ID Numbers: CDR0000067466; ECOG-8597
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004225
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
2. Lometrexol Plus Folic Acid in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
3. Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Unresectable Brain Metastases From Non-Small Cell Lung Cancer
4. CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer
5. T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Tennessee Clinical Trials
Other Nashville Clinical Trials
Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
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