Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L)

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. Identifier: NCT01279798
Expanded Access Status : No longer available
First Posted : January 19, 2011
Last Update Posted : March 1, 2011
Information provided by:
NovaRx Corporation

Brief Summary:
This is an expanded access protocol designed to make Lucanix® available to subjects with advanced non-small cell lung cancer (NSCLC) who are not eligible for the Phase III Protocol, NR001-03. A total of 45 patients will be enrolled into the study.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Biological: Lucanix® (belagenpumatucel-L)

Detailed Description:

The primary objective of this study is to increase the overall survival of the study subjects by providing expanded access to Lucanix. Overall survival and progression-free survivals will be compared with historical controls.

The secondary objectives of this study are:

  • Evaluate the best overall tumor response.
  • Evaluate progression-free survival (PFS).
  • Evaluate treatment toxicity.

Study Type : Expanded Access
Official Title: Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer.

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Intervention Details:
  • Biological: Lucanix® (belagenpumatucel-L)
    Subjects will receive up to 12 monthly (28-35 day interval) Lucanix injections at a dose of 2.5 × 10e7 cells per injection.
    Other Name: Lucanix

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Signed informed consent
  • ≥ 18 years
  • Histological confirmed non-curable stage III or IV NSCLC.
  • Must have completed at least one (1) regimen of anti-cancer therapy.
  • Following frontline therapy, subjects must observe the following wash- out periods:

    • Subjects with stable disease or better must have received the last anti-cancer therapy not less than five months prior to enrollment.
    • Subjects with progressive disease must have received the last anti-cancer therapy at least one (1) month prior to enrollment.
  • All subjects who have received two (2) or more regimens of therapy must have received the last anti-cancer therapy at least one (1) month prior to enrollment.
  • Performance status (ECOG) ≤ 2
  • Absolute granulocyte count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Total Bilirubin ≤ 2× Upper Limit of Normal
  • AST and ALT ≤ 2× Upper Limit of Normal
  • Creatinine ≤ 2× Upper Limit of Normal
  • Negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

  • Concurrent systemic steroids > 2 mg prednisone/day
  • Prior splenectomy
  • Any chemotherapy, steroid therapy, or investigational anti-cancer agent within 4 weeks of study entry.
  • Subjects who received prior monotherapy with Lucanix.
  • Symptomatic brain metastases unless treated and stable for ≥ 2 months
  • Known HIV positivity
  • 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 non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years
  • History of psychiatric disorder that would impede adherence to protocol
  • Pregnant or nursing women or refusal to practice contraception if of reproductive potential

Information from the National Library of Medicine

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 identifier (NCT number): NCT01279798

United States, California
Innovative Research Center of California
San Diego, California, United States, 92103
Sponsors and Collaborators
NovaRx Corporation

Publications of Results:
Responsible Party: Habib Fakhrai, PhD, Chief Scientific Officer and Executive Vice Chairman of the Board, NovaRx Corporation Identifier: NCT01279798     History of Changes
Other Study ID Numbers: NR001-04
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: January 2011

Keywords provided by NovaRx Corporation:
Lung Cancer
stage III or IV NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms