Non-Small Cell Lung Cancer - Completely ResectablePhase 1/2NCT00298298
DNP-Modified Autologous Tumor Cell Vaccine for Resectable Non-Small Cell Lung Cancer
A Phase 1/2 study testing L-Vax: Autologous, DNP-Modified NSCLC Vaccine in people with Non-Small Cell Lung Cancer - Completely Resectable, run by AVAX Technologies at 2 sites in United States.
Trial summary
To determine if a vaccine made from patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Cancer - Completely Resectable
- What is being tested?
- L-Vax: Autologous, DNP-Modified NSCLC Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2006to Jan 2014
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically documented stage IA, IB, IIA, IIB or IIIA NSCLC that is completely resectable and does not require post-operative radiation therapy or peri-operative chemotherapy
- Excision of the tumor and harvesting of tumor mass yielding adequate cells for vaccine manufacture and DTH testing
- Successful preparation and lot release of vaccines and of DTH testing material containing DNP-modified tumor cells
- Minimum of 3 and maximum of 8 weeks since the surgery
- Expected survival of at least 6 months
- Karnofsky performance status ³ 80
- Signed informed consent
Who cannot join
- Alkaline phosphatase > 2.5 x ULN
- Total bilirubin > 2.0 mg/dL
- Creatinine > 2.0 mg/dL
- Hemoglobin < 10.0 g/dL
- WBC < 3,000 /mm3
- Platelet count < 100,000/mm3
Show all 25Show fewer
- Chemotherapy - pre-operative or post-operative (except as designated in protocol)
- Radiation therapy to lung - pre-operative or post-operative
- Any major field radiotherapy within 6 months prior to participation in the study
- Immunotherapy (interferons, tumor necrosis factor, other cytokines [e.g., interleukins], biological response modifiers, or monoclonal antibodies) within 4 weeks prior to participation in the study
- Prior splenectomy
- Concurrent use of systemic steroids, except for the period of administration of the adjuvant chemotherapy, as per Section 8.6 (months 4-7)(Note: Topical steroid therapies [applied to the skin] are allowed, provided these are not applied to limbs injected with vaccine or skin test materials. Inhaled aerosol steroids are allowed.)
- Concurrent use of immunosuppressive drugs, except for the period of administration of the adjuvant chemotherapy (months 4-7)
- Concurrent use of antitubercular drugs (isoniazid, rifampin, streptomycin)
- Other malignancy within 5 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ of the uterine cervix, or early stage (stage A or B1) prostate cancer
- Concurrent autoimmune diseases, e.g., systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis
- Concurrent medical condition that would preclude compliance or immunologic response to study treatment
- Concurrent serious infection or other serious medical condition
- Receipt of any investigational medication within 4 weeks prior to participation in the study
- Pregnancy or lactation (serum b-human chorionic gonadotropin [b-HCG] test must be negative in fertile women at screening visit)
- Active tuberculosis or a past history of tuberculosis
- PPD positive (³ 5 mm to 5TU)
- Known gentamicin sensitivity
- Anergic, defined by the inability to make a DTH to at least one of the following: candida, mumps, tetanus or trichophyton (based, except for the period of administration of the adjuvant chemotherapy (months 4-7) upon availability)
- Vaccine lot release failure
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Highlands Oncology Group
Fayetteville, Arkansas, 72703
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: L-Vax: A Feasibility Study Using a DNP-Modified Autologous Tumor Cell Vaccine as Therapy in Patients With Resectable Non-Small Cell Lung Cancer
To determine if a vaccine made from patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine
Read the detailed description
Study Objectives: To study the toxicity, safety and delayed-type hypersensitivity (DTH) responses of DNP-modified autologous tumor cell vaccine (L-Vax) in patients with resectable NSCLC:
- To determine the tolerability and toxicity of L-Vax
- To determine whether L-Vax induces a DTH response to autologous, DNP-modified NSCLC cells of similar magnitude to responses observed with melanoma
- Determine whether L-Vax induces a DTH response to autologous unmodified NSCLC cells
- To determine whether the DTH responses to autologous, unmodified NSCLC cells that have been fixed with ethanol correlate with DTH responses to autologous, unmodified NSCLC cells that are not fixed
Study Population: Patients with resectable NSCLC whose therapeutic tumor surgery provides a mass, which yields adequate tumor, cells for vaccine preparation and DTH testing
Study Design: A Phase I/IIa double-blind, three-dose, single center study
Investigational Product: L-Vax: DNP-modified autologous NSCLC cell vaccine
Dosage Form: Cell suspension
Route of Administration: Intradermal
Dosage and Treatment Schedule: Prior to vaccine administration, patients will be tested for DTH to autologous NSCLC cells that have been: DNP-modified, or unmodified and irradiated, or unmodified and irradiated and fixed with ethanol (if sufficient cells available) Three doses of vaccine will be tested: 5 x 105, 2.5 x 106, or 5 x 106 DNP-modified autologous NSCLC cells. An initial dose of DNP-modified autologous NSCLC cells* without Bacillus of Calmette and Guérin (BCG) followed by cyclophosphamide (CY) then weekly doses of DNP-modified autologous NSCLC tumor cells mixed with BCG for 6 weeks, and completed with one dose of DNP-modified autologous NSCLC tumor cells mixed with BCG as a 6-month booster, if adequate number of cells available.
- count determined prior to aliquoting for cryopreservation
Endpoints: Treatment-emergent and related adverse events, serious adverse events, and Grade 3 and 4 laboratory abnormalities for safety assessments
Other Parameters: · DTH skin reactions for assessing the induction of immune responses to DNP-modified and unmodified autologous NSCLC tumor cells· Survival· Exploratory analysis of in vitro studies of peripheral blood lymphocytes obtained from study subjects
Duration of Treatment: Up to 9 months
Duration of Subject Participation in Study: Three months from the patient's last vaccine
Duration of Follow-up: Survival information and disease status will be collected via phone or visit on a quarterly basis for each patient beginning 30 days after the last scheduled visit until the last patient has been followed for three months from his/her last vaccine
Number of Subjects Required to Meet Protocol Objectives: Up to 42 evaluable subjects
Number of Study Centers: Three
Number of Individual Blood Draws: 15 draws over nine months
Volume of Blood Drawn: 13 Draws of 30 mL/draw (total 360 mL) and two draws of 50mL in heparinized tubes
- Being tested
- L-Vax: Autologous, DNP-Modified NSCLC Vaccine
- Keywords
- lung cancer, non-small cell lung cancere, vaccine, immunotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Vax: Autologous, DNP-Modified NSCLC VaccineBiological
autologous, DNP-modified NSCLC cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 5 million autologous, DNP-modified NSCLC cells Receives: Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine |
| 2 | Experimental | 2.5 million autologous, DNP-modified NSCLC cells Receives: Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine |
| 3 | Experimental | 0.5 million autologous, DNP-modified NSCLC cells Receives: Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell-mediated immunity to autologous tumor cells.
Measured: 3 months
Safety
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Suspended until capitalization is completed
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 Cancer - Completely ResectableStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVAX Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry E Schea, Study director, AVAX Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298298
- Sponsor's protocol ID
- A/100/0601
- Status last verified
- Dec 2015
- First submitted
- 28 Feb 2006
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berd D, Sato T, Cohn H, Maguire HC Jr, Mastrangelo MJ. Treatment of metastatic melanoma with autologous, hapten-modified melanoma vaccine: regression of pulmonary metastases. Int J Cancer. 2001 Nov;94(4):531-9. doi: 10.1002/ijc.1506.abs.
PubMed 11745440
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Vax: A Feasibility Study Using a DNP-Modified Autologous Tumor Cell Vaccine as Therapy in Patients With Resectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00298298
- Acronym / sponsor ID
- A/100/0601
- Keywords
- lung cancer, non-small cell lung cancere, vaccine, immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended until capitalization is completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AVAX TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Mar 2006 (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.
To determine if a vaccine made from patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine
Detailed description
Study Objectives: To study the toxicity, safety and delayed-type hypersensitivity (DTH) responses of DNP-modified autologous tumor cell vaccine (L-Vax) in patients with resectable NSCLC:
- To determine the tolerability and toxicity of L-Vax
- To determine whether L-Vax induces a DTH response to autologous, DNP-modified NSCLC cells of similar magnitude to responses observed with melanoma
- Determine whether L-Vax induces a DTH response to autologous unmodified NSCLC cells
- To determine whether the DTH responses to autologous, unmodified NSCLC cells that have been fixed with ethanol correlate with DTH responses to autologous, unmodified NSCLC cells that are not fixed
Study Population: Patients with resectable NSCLC whose therapeutic tumor surgery provides a mass, which yields adequate tumor, cells for vaccine preparation and DTH testing
Study Design: A Phase I/IIa double-blind, three-dose, single center study
Investigational Product: L-Vax: DNP-modified autologous NSCLC cell vaccine
Dosage Form: Cell suspension
Route of Administration: Intradermal
Dosage and Treatment Schedule: Prior to vaccine administration, patients will be tested for DTH to autologous NSCLC cells that have been: DNP-modified, or unmodified and irradiated, or unmodified and irradiated and fixed with ethanol (if sufficient cells available) Three doses of vaccine will be tested: 5 x 105, 2.5 x 106, or 5 x 106 DNP-modified autologous NSCLC cells. An initial dose of DNP-modified autologous NSCLC cells* without Bacillus of Calmette and Guérin (BCG) followed by cyclophosphamide (CY) then weekly doses of DNP-modified autologous NSCLC tumor cells mixed with BCG for 6 weeks, and completed with one dose of DNP-modified autologous NSCLC tumor cells mixed with BCG as a 6-month booster, if adequate number of cells available.
- count determined prior to aliquoting for cryopreservation
Endpoints: Treatment-emergent and related adverse events, serious adverse events, and Grade 3 and 4 laboratory abnormalities for safety assessments
Other Parameters: · DTH skin reactions for assessing the induction of immune responses to DNP-modified and unmodified autologous NSCLC tumor cells· Survival· Exploratory analysis of in vitro studies of peripheral blood lymphocytes obtained from study subjects
Duration of Treatment: Up to 9 months
Duration of Subject Participation in Study: Three months from the patient's last vaccine
Duration of Follow-up: Survival information and disease status will be collected via phone or visit on a quarterly basis for each patient beginning 30 days after the last scheduled visit until the last patient has been followed for three months from his/her last vaccine
Number of Subjects Required to Meet Protocol Objectives: Up to 42 evaluable subjects
Number of Study Centers: Three
Number of Individual Blood Draws: 15 draws over nine months
Volume of Blood Drawn: 13 Draws of 30 mL/draw (total 360 mL) and two draws of 50mL in heparinized tubes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine5 million autologous, DNP-modified NSCLC cells |
| 2 | Experimental | Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine2.5 million autologous, DNP-modified NSCLC cells |
| 3 | Experimental | Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine0.5 million autologous, DNP-modified NSCLC cells |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically documented stage IA, IB, IIA, IIB or IIIA NSCLC that is completely resectable and does not require post-operative radiation therapy or peri-operative chemotherapy
- Excision of the tumor and harvesting of tumor mass yielding adequate cells for vaccine manufacture and DTH testing
- Successful preparation and lot release of vaccines and of DTH testing material containing DNP-modified tumor cells
- Minimum of 3 and maximum of 8 weeks since the surgery
- Expected survival of at least 6 months
Key exclusion criteria (25 listed)
- Alkaline phosphatase > 2.5 x ULN
- Total bilirubin > 2.0 mg/dL
- Creatinine > 2.0 mg/dL
- Hemoglobin < 10.0 g/dL
- WBC < 3,000 /mm3
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 |
|---|---|---|
| L-Vax: Autologous, DNP-Modified NSCLC Vaccineautologous, DNP-modified NSCLC cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months | Biological | 1, 2, 3 |
Primary outcome
Cell-mediated immunity to autologous tumor cells.
Time frame: 3 months
Safety
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Suspended until capitalization is completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Background: PubMed 11745440Berd D, Sato T, Cohn H, Maguire HC Jr, Mastrangelo MJ. Treatment of metastatic melanoma with autologous, hapten-modified melanoma vaccine: regression of pulmonary metastases. Int J Cancer. 2001 Nov;94(4):531-9. doi: 10.1002/ijc.1506.abs.
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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.
Henry E Schea study director
AVAX Technologies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing L-Vax: Autologous, DNP-Modified NSCLC Vaccine in people with Non-Small Cell Lung Cancer - Completely Resectable, run by AVAX Technologies at 2 sites 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 7 inclusion and 25 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: stopped early, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Suspended until capitalization is completed). 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.
What does the primary outcome measure?
Cell-mediated immunity to autologous tumor cells. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298298, 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 3 Dec 2015.