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

This study has been completed.
Sponsor:
Information provided by:
NovaRx Corporation
ClinicalTrials.gov Identifier:
NCT01058785
First received: January 27, 2010
Last updated: July 28, 2010
Last verified: January 2010
  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:


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

  Show Detailed Description

  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:
Publications:
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:
Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014