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

February 25, 2011 updated by: NovaRx Corporation

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

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • Innovative Research Center of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NovaRx Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 29, 2010

First Submitted That Met QC Criteria

January 18, 2011

First Posted (ESTIMATE)

January 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 1, 2011

Last Update Submitted That Met QC Criteria

February 25, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR001-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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