Non-small Cell Lung CancerNCT01279798
Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L)
A study testing Lucanix® (belagenpumatucel-L) in people with Non-small Cell Lung Cancer, run by NovaRx Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Lucanix® (belagenpumatucel-L)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Innovative Research Center of California
San Diego, California, 92103
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Lucanix® (belagenpumatucel-L)
- Keywords
- Lung Cancer, NSCLC, stage III or IV NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucanix® (belagenpumatucel-L)Biological
Also called Lucanix
Subjects will receive up to 12 monthly (28-35 day interval) Lucanix injections at a dose of 2.5 × 10e7 cells per injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- NovaRx Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279798
- Sponsor's protocol ID
- NR001-04
- Status last verified
- Jan 2011
- First submitted
- 29 Oct 2010
- Last updated
- 1 Mar 2011
- Results posted
- No
Publications
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.
PubMed 16966690
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT01279798
- Acronym / sponsor ID
- NR001-04
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Lung Cancer, NSCLC, stage III or IV NSCLC
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- NovaRx CorporationIndustry (pharma, biotech, devices)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lucanix® (belagenpumatucel-L)Also: LucanixSubjects will receive up to 12 monthly (28-35 day interval) Lucanix injections at a dose of 2.5 × 10e7 cells per injection. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2011.
- Results publication: PubMed 16966690Nemunaitis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lucanix® (belagenpumatucel-L) in people with Non-small Cell Lung Cancer, run by NovaRx Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01279798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2011.