Phase II Study of Lucanix™ in Patients With Stages II-IV Non-Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Lung Neoplasm, Carcinoma, Bronchogenic

In brief

In this Phase II clinical trial the investigators will use four human non-small cell lung cancer cell lines that have been previously established in tissue culture laboratory. The investigators will gene modify these tumor cells in the laboratory to block their TGF-beta secretion. The investigators will inject the genetically engineered cells as vaccines in patients with stages II to IV non-small cell lung cancer. Our rationale for using other people's tumor cells is that lung tumor cell lines belonging to different people have been shown to share common characteristics that are recognized by non-self immune systems.

Key facts

Study ID

NCT01058785

Run by

NovaRx Corporation

People needed

75

Starts

2003-03-01

Expected to finish

2005-12-01

Last updated by the study team

2010-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• 18 years
• Histologically confirmed non-curable NSCLC with an estimated total tumor burden volume of less than or equal to 125 cc, confirmed to be stage II, III, or IV.
• Must have completed or refused conventional therapy
• Performance status (ECOG) less than 2.
• Absolute granulocyte count greater than or equal to 1,500/mm3
• Platelet count greater than or equal to 100,000/mm3
• Total Bilirubin less than or equal to 2 mg/dL
• AST and ALT less than or equal to 2x Upper Limit of Normal
• Creatinine less than or equal to 1.5 mg/Dl

You may not qualify if…

• Concurrent systemic steroids greater than 2 mg prednisone/day
• Prior splenectomy
• Any surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy or immunotherapy less than 4 weeks of study entry
• Brain metastases or meningeal lymphomatosis unless treated and stable for ≥ 2 months
• Known HIV positive
• Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives.
• Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission for greater than or equal to 2 years
• Treatment with an investigational drug within 30 days prior to study entry
• History of psychiatric disorder that would impede adherence to protocol
• Pregnant or nursing women or refusal to practice contraception if of reproductive potential

Where it is running

• Hoag Cancer Center — Newport Beach, California, United States
• Jayne Gurtler MD, Laura Brinz MD, Angelo Russo MD, and Janet Burroff MD APM — Metairie, Louisiana, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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