Clinical Trial: Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer
This study is currently recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
|Non-small cell lung cancer |
Small Cell Lung Cancer
| Gene Transfer: DOTAP:Chol-fus1 ||Phase I |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lung Cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I Study Of Intravenous DOTAP:Cholesterol-Fus1 Liposome Complex (DOTAP:Chol-fus1) In Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy
Expected Total Enrollment: 30
Study start: March 2003
Genders Eligible for Study: Both
- Histologically or cytologically documented non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).
- For NSCLC Patients: 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.
- For SCLC Patients: Extensive disease or recurrent disease after initial treatment for limited disease. Patients must have received prior platinum-based chemotherapy or chemoradiotherapy.
- All patients: There is no limit to the number of prior chemotherapy regimens received. 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.
- 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). Subjects are requied to practice effective birth control during the study period.
- Negative serology for Human Immunodeficiency Virus.
- Must have recovered from any surgical procedure.
- ANC > 1500 x 10**9/mm**3, plt count > 100,000 x 10**9/mm**3.
- PT and PTT are within institutional normal parameters
- 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 and SGPT </= 1.5 x upper limit of normal.
- Patients with asymptomatic brain metastases that have been treated are eligible if the following criteria are met: No history of seizures. Definitive treatment must have been completed >/= 4weeks prior to registration. Subjects must be off steroids for >/= 2 weeks. Post-treatment imaging within 2 weeks of registration must demonstrate stability or regression of the brain metastases.
- Stable cardiac condition with a left ventricular fraction > 50%.
- FEV1 and DLCO of >/= 40% of predicted.
- Females who are pregnant or breast-feeding.
- Individuals who received chemotherapy or radiotherapy within 30 days of entry into the protocol.
- Active systemic viral, bacterial or fungal infections requiring treatment.
- Brain metastases (except as allowed in the above inclusion criteria). Neurological assessment will be used to determine 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.
- History of myocardial infarction within 6 months, angina, or a history of arrhythmias on active therapy.
Location and Contact Information
Rhodette Francisco, RN 713-745-1093
University of Texas M.D. Anderson Cancer Center, Houston, Texas, 77030, United States; Recruiting
Rhodette Francisco, RN 713-745-1093
Charles Lu, MD, Principal Investigator
Jack Roth, MD, Sub-Investigator
Record last reviewed: January 2005
Last Updated: January 31, 2005
Record first received: April 29, 2003
ClinicalTrials.gov Identifier: NCT00059605
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005