TerminatedNCT00298298Updated Dec 3, 2015

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

A Phase 1/2 interventional study of L-Vax: Autologous, DNP-Modified NSCLC Vaccine in Non-Small Cell Lung Cancer - Completely Resectable, sponsored by AVAX Technologies. Terminated at 2 sites in United States. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by AVAX Technologies · Phase 1/2, Interventional, and Treatment

Why this study was terminated

Suspended until capitalization is completed

Phase: Phase 1/2
Study type: Interventional
Enrollment: 6
Allocation: Randomized
Sex: All

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

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

Conditions studied

Non-Small Cell Lung Cancer - Completely Resectable

Browse trials for

Lung Neoplasms 7,333

Keywords

lung cancer
non-small cell lung cancere
vaccine
immunotherapy

In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's enrollment of 6 is below the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

AVAX Technologies is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion 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

Exclusion criteria

Exclusion 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

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 6 participants (actual)

Study arms

Experimental
1
5 million autologous, DNP-modified NSCLC cells
Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine
Experimental
2
2.5 million autologous, DNP-modified NSCLC cells
Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine
Experimental
3
0.5 million autologous, DNP-modified NSCLC cells
Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine

Interventions

BiologicalL-Vax: Autologous, DNP-Modified NSCLC Vaccine
autologous, DNP-modified NSCLC cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months

What researchers measure

Primary outcomes

Cell-mediated immunity to autologous tumor cells.
Time frame: 3 months
Safety
Time frame: 1 year

Study locations

2 sites

Highlands Oncology Group
Fayetteville, Arkansas 72703, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania 19104, United States

References and documents

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 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2006, a primary completion of Jan 2014 and a completion of Jan 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 28, 2006
First posted: Mar 2, 2006
Start: Jan 2006
Primary completionActual: Jan 2014
CompletionActual: Jan 2014
Last update: Dec 3, 2015

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00298298
Lead sponsor: AVAX Technologies
Responsible party: Sponsor
First posted: Mar 2, 2006
Start date: Jan 2006
Primary completion: Jan 2014
Completion: Jan 2014
Last update: Dec 3, 2015

Study contacts

Henry E Schea

study director · AVAX Technologies

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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