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Home > "P" Clinical Trials Conditions > Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer  Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer
Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer
For Condition: Non-small cell lung cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: DOTAP:Chol-fus1 is a drug that helps transfer the fus1 gene into cancer cells. It is thought that the absence of the fus1 gene may be involved in the development of lung cancer tumors. The idea is to try to replace this gene in lung cancer cells. The purpose of this study is to assess the toxicity of the drug DOTAP:Chol-fus1 and to determine the best dose of this drug for future studies.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion critera: - Histologically or cytologically documented non-small cell lung cancer (NSCLC). - Recurrent or locally advanced, unresectable stage IIIB (pleural effusion) or stage IV NSCLC. - Must have received at least one prior chemotherapy regimen for recurrent or locally advanced, unresectable stage IIIB (pleural effusion) or stage IV NSCLC. There is no limit to the number of prior chemotherapy regimens received. - Preference will be given to individuals with excellent performance status and tumors amenable to biopsy. - Must have a life expectancy of at least 12 weeks. - Karnofsky Performance Status > 70%. - Negative serum pregnancy test (serum HCG) if female and of childbearing potential (non-childbearing is defined as greater than one year post-menopausal or surgically sterilized). - Negative serology for Human Immunodeficiency Virus. - Must have recovered from any surgical procedure. - ANC > 1500 x 109/mm3, plt count > 100,000 x 109/mm3. - PT < 14 sec, PTT < 38 sec. - Adequate renal function documented by serum creatinine of < 1.5 mg/dl or calculated creatinine clearance > 50 ml/min. - Adequate hepatic function as documented by serum bilirubin< 1.5 mg/dl and SGOT (ALT). - Stable cardiac condition (New York Heart Classification 30% of predicted. Exclusion criteria: - Pregnant or lactating females. - Individuals who received chemotherapy within 30 days of entry into the protocol. - Active systemic viral, bacterial or fungal infections requiring treatment. - Brain metastases. - Serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that do not permit adequate follow-up and compliance with the study protocol. - Use of any investigational agent within four weeks of study treatment. - Prior gene therapy.
Total Enrollment: 30
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting A Sarabia 713-792-4345
Additional Information:
Study ID Numbers: ID00-123;
Study Start Date: March 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059605
Other Non-Small Cell Lung Cancer Studies:
1. Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma
2. Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
3. KRN7000 in Treating Patients With Solid Tumors
4. Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer
5. Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer
Related Studies:
Other Non-small cell lung cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer
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