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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
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: 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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014