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

July 28, 2010 updated by: NovaRx Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a 2-stage, open-label, three-arm, Phase II study. It is designed to evaluate the efficacy of immunization with increasing doses of an allogeneic tumor cell vaccine, Lucanix™, in patients with non-curable NSCLC. Patients will be followed for clinical response, immunogenicity and safety.

Eligible patients will receive 4 monthly intradermal injections with a cell cocktail comprised of equal numbers of four irradiated allogeneic TGF-beta2 antisense gene modified NSCLC cell lines. Patients will be randomized to one of the three study cohorts. Patients will receive 12,500,000, 25,000,000, 50,000,000 gene modified cells respectively. Treated patients will be evaluated four months after they enter therapy. Patients that respond to therapy will receive an additional four to twelve injections to evaluate whether their response to therapy can be amplified. Response, time to tumor progression, and tumor free survival will be monitored in patients and compared with historical controls and patients receiving other forms of therapy. Patients will be monitored and evaluated according to standard evaluation criteria of no response, stable disease, partial response and complete response.

PRIMARY OBJECTIVE

-Evaluate the ability of increasing doses of Lucanix™, a gene-modified tumor cell vaccine, to induce tumor response in patients with non-curable NSCLC

SECONDARY OBJECTIVES

  • Evaluate the ability of the Lucanix™ vaccination regimen to induce an immune response (cellular and humoral)
  • Estimate the response duration for the Lucanix™ regimen
  • Evaluate the effects of repeated inoculations on immune infiltrates
  • Evaluate the safety of the Lucanix™ regimen

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 then 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 greater than or equal to 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

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

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
      • Newport Beach, California, United States, 92658
        • Hoag Cancer Center
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Jayne Gurtler MD, Laura Brinz MD, Angelo Russo MD, and Janet Burroff MD APM
    • Texas
      • Dallas, Texas, United States, 75201
        • Mary Crowley Medical Research Center

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

No

Genders Eligible for Study

All

Description

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

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • belagenpumatucel-L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Week 16, quarterly during treatment and first year of post-intervention follow-up

Collaborators and Investigators

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

Sponsor

NovaRx Corporation

Investigators

  • Study Director: Habib Fakhrai, PhD, 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 Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Estimate)

July 29, 2010

Last Update Submitted That Met QC Criteria

July 28, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB-IND 8868

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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