Back to resultsExpanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L)
Primary Purpose
Non-small Cell Lung Cancer
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Lucanix® (belagenpumatucel-L)
Sponsored by
About this trial
This is an expanded access trial for Non-small Cell Lung Cancer focused on measuring Lung Cancer, NSCLC, stage III or IV NSCLC
Eligibility 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
Sites / Locations
- Innovative Research Center of California
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01279798
Brief Title
Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L)
Official Title
Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer.
Study Type
Expanded Access
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
NovaRx Corporation
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Lung Cancer, NSCLC, stage III or IV NSCLC
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Lucanix® (belagenpumatucel-L)
Other Intervention Name(s)
Lucanix
Intervention Description
Subjects will receive up to 12 monthly (28-35 day interval) Lucanix injections at a dose of 2.5 × 10e7 cells per injection.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Facility Information:
Facility Name
Innovative Research Center of California
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16966690
Citation
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.
Results Reference
result
Links:
URL
http://www.novarx.com/
Description
NovaRx Website
Learn more about this trial
Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L)
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