Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer

Completed · Phase 1

Conditions studied: Lung Cancer

In brief

The goal of this clinical research study is to find out the highest safe dose of DOTAP:Chol-fus1 that can be given to participants in the treatment of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). This study is an attempt to transfer a gene (fus1) into cancer cells, using the drug DOTAP:Cholesterol-fus1. Researchers will also study the side effects of this experimental gene transfer at different doses, and will conduct tests to see if there are any effects on tumor size at different doses. Experimental transfer of the fus1 gene into humans has never been tried before. Objectives: * Assess the toxicity of DOTAP:Cholesterol-fus1 Liposome Complex (DOTAP:Chol-fus1) administered intravenously. * To determine the maximal tolerated dose and recommended phase II dose of DOTAP:Chol-fus1 administered intravenously. * Assess the expression of fus1 following intravenous delivery of DOTAP:Chol-fus1 in tumor and normal bronchial epithelial cell biopsies. * Assess any anti-cancer activity for DOTAP:Chol-fus1.

Key facts

Study ID: NCT00059605
Run by: M.D. Anderson Cancer Center
People needed: 32
Starts: 2003-03-01
Expected to finish: 2011-04-01
Last updated by the study team: 2012-02-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically documented non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
For NSCLC subjects: Locally advanced, unresectable, incurable stage IIIB (pleural effusion) or stage IV NSCLC, or recurrent NSCLC that is not potentially curable by radiotherapy or surgery. Patients must have received at least one prior platinum-based chemotherapy regimen for NSCLC. For SCLC subjects: Extensive disease or recurrent disease after initial treatment for limited disease. Patients must have received prior platinum-based chemotherapy or chemoradiotherapy. All subjects: There is no limit to the number of prior chemotherapy regimens received.
Preference will be given to patients with tumors amenable to biopsy. In the expansion cohort at MTD, all patients must have tumor amenable to biopsy and must consent to biopsy.
Karnofsky Performance Status >= 70%, or Zubrod Performance Status <= 1.
Negative serum pregnancy test (serum HCG) if female and of childbearing potential. Since beta-HCG may be falsely elevated as a result of malignancy, women of child-bearing potential who have an elevated serum beta-HCG level are eligible for enrollment if they have two Transvaginal Ultrasound (TVUS) scans one week apart and serial beta-HCG levels two weeks apart that are inconsistent with pregnancy and a Gynecology consult to ensure that the beta- HCG level was at a value high enough to see pregnancy with TVUS. Subjects must agree to practice effective birth control during the study period.
Negative serology for Human Immunodeficiency Virus.
Patients must be >/= 4 weeks beyond major surgical procedures such as thoracotomy, laparotomy or joint replacement, and must be >/= 1.5 weeks beyond minor surgical procedures such as biopsy of subcutaneous tumors, pleuroscopy, etc, and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery. Absolute neutrophil count (ANC) > 1500 * 10**9/mm**3, platelet count > 100,000 * 10**9/mm**3. Prothrombin time (PT) and Partial thromboplastin time (PTT) < 1.25 times the institutional upper limit of normal.
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 * upper limit of normal.
FEV1 and corrected DLCO of >/= 40% of predicted.
Patients with asymptomatic brain metastases that have been treated are eligible if the following criteria are met: No history of seizures in the preceding 6 months. Definitive treatment must have been completed ≥4weeks prior to registration. Subjects must be off steroids that were being administered because of brain metastases or related symptoms 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 ejection fraction > 50%.
Patients must have voluntarily signed an informed consent in accordance with institutional policies.

You may not qualify if…

Females who are pregnant or breast-feeding.
Patients who received investigational therapy, monoclonal antibody such as bevacizumab or cetuximab, or who received radiotherapy to the skull, spine, thorax or pelvis within 30 days of entry into the protocol. Patients are permitted to have received palliative radiotherapy to an extremity provided at least 14 days has elapsed since completion of therapy, provided the patient received no more than 10 radiotherapy fractions and a dose no higher than 30 Gy to that site, and provided skull, spine, thorax or pelvis were not in the radiotherapy field.
Patients with brain metastases (except as allowed in inclusion criterion #11). Neurological assessment will be used to determine brain metastases.
Active systemic viral, bacterial or fungal infections requiring treatment.
Patients with serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the investigator, would 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 within the past 6 months, or a history of arrhythmias on active therapy.
Patients who have received standard chemotherapy with FDA approved agents within 21 days of entry into the protocol.
Patients who have received therapy with an oral tyrosine kinase inhibitor (eg, erlotinib) within 14 days prior to entry into the protocol.

Where it is running

University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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