DNP-Modified Autologous Tumor Cell Vaccine for Resectable Non-Small Cell Lung Cancer
NCT ID: NCT00298298
Last Updated: 2015-12-03
Study Results
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Basic Information
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TERMINATED
PHASE1/PHASE2
6 participants
INTERVENTIONAL
2006-01-31
2014-01-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
5 million autologous, DNP-modified NSCLC cells
L-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
2
2.5 million autologous, DNP-modified NSCLC cells
L-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
3
0.5 million autologous, DNP-modified NSCLC cells
L-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
Interventions
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L-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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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AVAX Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Henry E Schea
Role: STUDY_DIRECTOR
AVAX Technologies
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
Other Identifiers
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A/100/0601
Identifier Type: -
Identifier Source: org_study_id