Phase II Study of Lucanix™ in Patients With Stages II-IV Non-Small Cell Lung Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01058785 |
Recruitment Status :
Completed
First Posted : January 29, 2010
Last Update Posted : July 29, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Neoplasm Carcinoma, Bronchogenic | Biological: Lucanix | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | March 2003 |
Actual Primary Completion Date : | December 2005 |
Actual Study Completion Date : | December 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: Lucanix
Patients will receive injections of Lucanix for each dose cohort.
|
Biological: Lucanix
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.
Other Name: belagenpumatucel-L |
- Evaluate the ability of increasing doses of Lucanix™, a gene-modified tumor cell vaccine, to induce tumor response in patients with non-curable NSCLC [ Time Frame: Week 16, quarterly during treatment and first year of post-intervention follow-up ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058785
United States, California | |
Hoag Cancer Center | |
Newport Beach, California, United States, 92658 | |
United States, Louisiana | |
Jayne Gurtler MD, Laura Brinz MD, Angelo Russo MD, and Janet Burroff MD APM | |
Metairie, Louisiana, United States, 70006 | |
United States, Texas | |
Mary Crowley Medical Research Center | |
Dallas, Texas, United States, 75201 |
Study Director: | Habib Fakhrai, PhD | NovaRx Corporation |
Publications of Results:
Other Publications:
Responsible Party: | Habib Fakhrai, Ph.D., NovaRx Corporation |
ClinicalTrials.gov Identifier: | NCT01058785 |
Other Study ID Numbers: |
BB-IND 8868 |
First Posted: | January 29, 2010 Key Record Dates |
Last Update Posted: | July 29, 2010 |
Last Verified: | January 2010 |
Gene therapy Flow cytometry Immunoenzyme technique Laboratory biomarker analysis Tumor cell-derivative vaccine therapy |
Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |