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

NCT00298298 | Terminated Phase 1 DMC

• 1 other identifier: A/100/0601
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Non-Small Cell Lung Cancer - Completely Resectable

Keywords

lung cancer; non-small cell lung cancere; vaccine; immunotherapy

Outcome Measures

Primary Outcomes (2)

• Cell-mediated immunity to autologous tumor cells.

  3 months

• Safety

  1 year

Study Arms (3)

1

EXPERIMENTAL

5 million autologous, DNP-modified NSCLC cells

Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine

2

EXPERIMENTAL

2.5 million autologous, DNP-modified NSCLC cells

Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine

3

EXPERIMENTAL

0.5 million autologous, DNP-modified NSCLC cells

Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine

Interventions

L-Vax: Autologous, DNP-Modified NSCLC Vaccine BIOLOGICAL

autologous, DNP-modified NSCLC cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months

1; 2; 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AVAX Technologies: lead

Study Sites (2)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 11745440 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Henry E Schea

  AVAX Technologies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2006
• First Posted: March 2, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (2)