Phase II Study of Lucanix™ in Patients With Stages II-IV Non-Small Cell Lung Cancer
Phase II Study of Lucanix™ (TGF-beta2 Antisense Gene Modified Allogeneic Tumor Cell Vaccine) in Patients With Stages II-IV Non-Small Cell Lung Cancer
1 other identifier
interventional
75
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2003
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 27, 2010
CompletedFirst Posted
Study publicly available on registry
January 29, 2010
CompletedJuly 29, 2010
January 1, 2010
2.8 years
January 27, 2010
July 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the ability of increasing doses of Lucanix™, a gene-modified tumor cell vaccine, to induce tumor response in patients with non-curable NSCLC
Week 16, quarterly during treatment and first year of post-intervention follow-up
Study Arms (1)
Lucanix
EXPERIMENTALPatients will receive injections of Lucanix for each dose cohort.
Interventions
Monthly intradermal injections of four irradiated allogeneic TGF-beta2 antisense gene modified NSCLC cell lines. Patients are randomized to receive either 12,500,000, 25,000,000 or 50,000,000 cells per injection for up to 16 injections.
Eligibility Criteria
You may qualify if:
- Signed informed consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hoag Cancer Center
Newport Beach, California, 92658, United States
Jayne Gurtler MD, Laura Brinz MD, Angelo Russo MD, and Janet Burroff MD APM
Metairie, Louisiana, 70006, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75201, United States
Related Publications (2)
Fakhrai H, Mantil JC, Liu L, Nicholson GL, Murphy-Satter CS, Ruppert J, Shawler DL. Phase I clinical trial of a TGF-beta antisense-modified tumor cell vaccine in patients with advanced glioma. Cancer Gene Ther. 2006 Dec;13(12):1052-60. doi: 10.1038/sj.cgt.7700975. Epub 2006 Jul 7.
PMID: 16826191BACKGROUNDNemunaitis J, Dillman RO, Schwarzenberger PO, Senzer N, Cunningham C, Cutler J, Tong A, Kumar P, Pappen B, Hamilton C, DeVol E, Maples PB, Liu L, Chamberlin T, Shawler DL, Fakhrai H. Phase II study of belagenpumatucel-L, a transforming growth factor beta-2 antisense gene-modified allogeneic tumor cell vaccine in non-small-cell lung cancer. J Clin Oncol. 2006 Oct 10;24(29):4721-30. doi: 10.1200/JCO.2005.05.5335. Epub 2006 Sep 11.
PMID: 16966690RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Habib Fakhrai, PhD
NovaRx Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 27, 2010
First Posted
January 29, 2010
Study Start
March 1, 2003
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
July 29, 2010
Record last verified: 2010-01