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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00503568
First received: July 17, 2007
Last updated: July 25, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: Ad100-gp96Ig-HLA A1
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Novel Tumor Vaccine gp96-Ig Fusion Protein in Advanced (Stage IIIB), Relapsed or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Failed First Line Chemotherapy

Resource links provided by NLM:


Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • Safety [ Time Frame: 6, 12, 18, 24, and 36 months post enrollment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunologic response: CD8, CD4 and NK response [ Time Frame: Baseline, Day 1 Week1, Day 1 Week 13, Day 1 Week 19 ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: May 2007
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allogeneic NSCLC/AD100-gp96-ig Vaccine Biological: Ad100-gp96Ig-HLA A1
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
Other Names:
  • gp96-vaccine
  • gp96-Ig and HLA A1 transfected Non-Small Cell Lung Cancer cell line

Detailed Description:

Overall Goals:

- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.

Primary Aim:

- to evaluate the safety of administering a heat shock protein gp96-Ig-secreting allogeneic tumor cell-vaccine (gp96-Ig vaccine) in patients with advanced NSCLC.

Secondary Aims:

  • to study the immune response to vaccination,
  • to monitor clinical responses and
  • to recommend a dose-schedule combination for further testing in an initial Phase II trial of vaccine efficacy.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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.
  • Autopsy consent - although not a requirement for study entry, patients who consent to participate in study will be made aware of the critical importance of a post-mortem examination in the event of the patient's death after receiving therapy with this experimental vaccine. Therefore, pre-treatment written agreement to autopsy will be sought from the patient, or verbal agreement to autopsy will be sought in the presence of the next of kin or other family members.

Exclusion Criteria

  • 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
    • DLCO < 30% of the predicted value, or
    • PCO2 > 45 mmHg.
  • Any patient enrolled on study whose respiratory symptoms have experienced marked deterioration not related to a known cause, such as pneumonia, congestive heart failure, or pulmonary embolism, will have a repeat PFT evaluation, and if the above parameter values for FeV1, DLCO, or PCO2 are seen, will be excluded from further treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503568

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Luis E. Raez, MD, FACP University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00503568     History of Changes
Obsolete Identifiers: NCT00247065
Other Study ID Numbers: UMIAMI-20020225, SCCC-2002041, WIRB-20050969
Study First Received: July 17, 2007
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014