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

Purpose

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.

Condition	Intervention	Phase
Lung Neoplasm Carcinoma, Bronchogenic	Biological: Lucanix	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: Camurati-Engelmann disease

MedlinePlus related topics: Cancer Genes and Gene Therapy Lung Cancer

Genetic and Rare Diseases Information Center resources: Camurati-Engelmann Disease

U.S. FDA Resources

Further study details as provided by NovaRx Corporation:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]


Enrollment:	75
Study Start Date:	March 2003
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058785

Locations


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

Sponsors and Collaborators

NovaRx Corporation

Investigators


Study Director:	Habib Fakhrai, PhD	NovaRx Corporation

More Information

Additional Information:

Clinical trial information This link exits the ClinicalTrials.gov site

Publications:

Nemunaitis 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. Epub 2006 Sep 11.

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. Epub 2006 Jul 7.


Responsible Party:	Habib Fakhrai, Ph.D., NovaRx Corporation
ClinicalTrials.gov Identifier:	NCT01058785 History of Changes
Other Study ID Numbers:	BB-IND 8868
Study First Received:	January 27, 2010
Last Updated:	July 28, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by NovaRx Corporation:


Gene therapy Flow cytometry Immunoenzyme technique Laboratory biomarker analysis Tumor cell-derivative vaccine therapy

Additional relevant MeSH terms:


Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Lung Diseases Lung Neoplasms	Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

ClinicalTrials.gov processed this record on March 02, 2015