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

NCT01279798 | Unknown

• 1 other identifier: NR001-04
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Lung Cancer; NSCLC; stage III or IV NSCLC

Interventions

Lucanix® (belagenpumatucel-L) BIOLOGICAL

Subjects will receive up to 12 monthly (28-35 day interval) Lucanix injections at a dose of 2.5 × 10e7 cells per injection.

Also known as: Lucanix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NovaRx Corporation: lead

Study Sites (1)

Innovative Research Center of California

San Diego, California, 92103, United States

Location

Related Publications (1)

• Nemunaitis J, Dillman RO, Schwarzenberger PO, Senzer N, Cunningham C, Cutler J, Tong A, Kumar P, Pappen B, Hamilton C, DeVol E, Maples PB, Liu L, Chamberlin T, Shawler DL, Fakhrai H. Phase II study of belagenpumatucel-L, a transforming growth factor beta-2 antisense gene-modified allogeneic tumor cell vaccine in non-small-cell lung cancer. J Clin Oncol. 2006 Oct 10;24(29):4721-30. doi: 10.1200/JCO.2005.05.5335. Epub 2006 Sep 11.

  PMID: 16966690 RESULT

Related Links

• NovaRx Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

belagenpumatucel L

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: January 19, 2011
• Last Updated: March 1, 2011

Record last verified: 2011-01

Locations

US (1)