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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
NovaRx Corporation
ClinicalTrials.gov Identifier:
NCT01279798
First received: October 29, 2010
Last updated: February 25, 2011
Last verified: January 2011
  Purpose

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 Intervention
Non-small Cell Lung Cancer
Biological: Lucanix® (belagenpumatucel-L)

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

Resource links provided by NLM:


Further study details as provided by NovaRx Corporation:

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
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279798

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

Additional Information:
Publications:
Responsible Party: Habib Fakhrai, PhD, Chief Scientific Officer and Executive Vice Chairman of the Board, NovaRx Corporation
ClinicalTrials.gov Identifier: NCT01279798     History of Changes
Other Study ID Numbers: NR001-04
Study First Received: October 29, 2010
Last Updated: February 25, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 21, 2014