DNP-Modified Autologous Tumor Cell Vaccine for Resectable Non-Small Cell Lung Cancer

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedL-Vax: Autologous, DNP-Modified NSCLC Vaccine

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 3, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?AVAX Technologies

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: AVAX Technologies
Interventions being studied: Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion criteria

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
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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Highlands Oncology GroupFayetteville, Arkansas
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 3, 2015. Always confirm current availability with the study team.

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