Vaccine Therapy in Treating Patients With Stage III, Stage IV, or Relapsed Non-Small Cell Lung Cancer Treated With First-Line Chemotherapy

NCT00503568 | Completed Phase 1 DMC

• 3 other identifiers: 20020225SCCC-2002041WIRB-20050969
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from a person's tumor cells may help the body build an effective immune response to kill non-small cell lung cancer cells. PURPOSE: This phase I trial is studying the effects of gp96-Ig vaccine therapy in treating patients with stage III, stage IV, or relapsed non-small cell lung cancer treated with first-line chemotherapy.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Safety

  6, 12, 18, 24, and 36 months post enrollment

Secondary Outcomes (1)

• Immunologic response: CD8, CD4 and NK response

  Baseline, Day 1 Week1, Day 1 Week 13, Day 1 Week 19

Study Arms (3)

DS-1: gp96-ig Dose Schedule 1

EXPERIMENTAL

Dose Schedule 1 (DS-1): Ad100-gp96Ig-HLA A1 Vaccine 4x10\^7 cells bi-weekly, maximum 9 vaccines/patient;

Biological: Ad100-gp96Ig-HLA A1

DS-2: gp96-ig Dose Schedule 3

EXPERIMENTAL

Dose Schedule 2 (DS-2): Ad100-gp96Ig-HLA A1 Vaccine 2X10\^7 cells weekly, maximum 18 vaccines/patient;

Biological: Ad100-gp96Ig-HLA A1

DS-3: gp96-ig Dose Schedule 3

EXPERIMENTAL

Dose Schedule 3 (DS-3): Ad100-gp96Ig-HLA A1 Vaccine 1x10\^7 cells twice weekly, maximum 36 vaccines/patient

Biological: Ad100-gp96Ig-HLA A1

Interventions

Ad100-gp96Ig-HLA A1 BIOLOGICAL

Dose Schedule 1 (DS-1): 4x10\^7 cells bi-weekly, maximum 9 vaccines/patient; Dose Schedule 2 (DS-2): 2X10\^7 cells weekly, maximum 18 vaccines/patient; Dose Schedule 3 (DS-3): 1x10\^7 cells twice weekly, maximum 36 vaccines/patient

Also known as: gp96-vaccine, gp96-Ig and HLA A1 transfected Non-Small Cell Lung Cancer cell line

DS-1: gp96-ig Dose Schedule 1; DS-2: gp96-ig Dose Schedule 3; DS-3: gp96-ig Dose Schedule 3

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed NSCLC (squamous, adeno-, large cell anaplastic, bronchoalveolar, and non-small cell carcinoma NOS): stage IIIB with malignant pleural effusion, stage IV, or recurrent disease.
• At least one site of bi-dimensionally measurable disease.
• Metastasis if present and treated must be stable by CT scan or MRI for at least 8 weeks.
• Patient must have received and failed at least one line of chemotherapy.
• Age \>= 18 years.
• ECOG performance status 0-2.
• Life expectancy \>= 3 months.
• Laboratory parameters:
• Hemoglobin levels \>= 10.0 (transfusions allowed if necessary).
• ANC \>= 1,500.
• Platelets \>= 100k.
• Creatinine clearance \>= 50 ml/min.
• Total and direct bilirubin: \< 2.5 X upper institution limit for normal.
• Liver function tests: AST, ALT, and AlkP \< 2.5 X upper institution limit for normal.
• Signed informed consent.

You may not qualify if:

• Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction. Patients with history of these conditions who are stable taking cardiac medications will also be excluded.
• Pregnant or lactating women (negative test for pregnancy is required of women of childbearing potential).
• Known HIV infection.
• Uncontrolled or untreated brain or spinal cord metastases.
• Active infection.
• Concomitant steroid or other immunosuppressive therapy.
• Other active malignancies present within the past three years, except for basal and/or squamous cell carcinoma(s) or in situ cervical cancer.
• Alcohol or chemical abuse.
• Meningeal carcinomatosis.
• Chemotherapy, radiation therapy, or other anti-tumor therapy during the last four weeks.
• Prior biologic response modifier therapy.
• Refusal in fertile men or women to use effective birth control measures during and for six months after the completion of treatment on study.
• Immune deficiency syndromes, including the following: rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease, sarcoidosis, vasculitis, polymyositis, glomerulonephritis.
• Compromised lung function:
• FeV1 \< 30% of the predicted value, or

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Related Publications (2)

• Raez LE, Cassileth PA, Schlesselman JJ, Sridhar K, Padmanabhan S, Fisher EZ, Baldie PA, Podack ER. Allogeneic vaccination with a B7.1 HLA-A gene-modified adenocarcinoma cell line in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2004 Jul 15;22(14):2800-7. doi: 10.1200/JCO.2004.10.197.

  PMID: 15254047 BACKGROUND

• Raez LE, Podack ER, CD8 T cell response in a phase I study of therapeutic vaccination of advanced NSCLC with allogeneic tumor cells secreting endoplasmic reticulum-chaperone gp96-Ig-peptide complexes. Advances in Lung Cancer 2(1): 9-18, 2013 doi:10.4236/alc.2013.21002

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Luis E. Raez, MD, FACP

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 19, 2007
• Study Start: May 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)