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

This study is currently recruiting patients.

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center


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.

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

Further Study Details: 

Expected Total Enrollment:  30

Study start: March 2003


Genders Eligible for Study:  Both


Inclusion critera:

  • 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.

Exclusion criteria:

  • 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

Faye Martin, RN      713-563-9156 
Rhodette Francisco, RN      713-745-1093 

      University of Texas M.D. Anderson Cancer Center, Houston,  Texas,  77030,  United States; Recruiting
Faye Martin, RN  713-563-9156 
Rhodette Francisco, RN  713-745-1093 
Charles Lu, MD,  Principal Investigator
Jack Roth, MD,  Sub-Investigator

More Information

Study ID Numbers:  ID00-123
Record last reviewed:  January 2005
Last Updated:  January 31, 2005
Record first received:  April 29, 2003 Identifier:  NCT00059605
Health Authority: United States: Food and Drug Administration processed this record on 2005-04-08

Cache Date: April 9, 2005