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

December 14, 2016 updated by: University of Miami

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DS-1: gp96-ig Dose Schedule 1
Dose Schedule 1 (DS-1): Ad100-gp96Ig-HLA A1 Vaccine 4x10^7 cells bi-weekly, maximum 9 vaccines/patient;
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
Experimental: DS-2: gp96-ig Dose Schedule 3
Dose Schedule 2 (DS-2): Ad100-gp96Ig-HLA A1 Vaccine 2X10^7 cells weekly, maximum 18 vaccines/patient;
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
Experimental: DS-3: gp96-ig Dose Schedule 3
Dose Schedule 3 (DS-3): Ad100-gp96Ig-HLA A1 Vaccine 1x10^7 cells twice weekly, maximum 36 vaccines/patient
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: 6, 12, 18, 24, and 36 months post enrollment
6, 12, 18, 24, and 36 months post enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunologic response: CD8, CD4 and NK response
Time Frame: Baseline, Day 1 Week1, Day 1 Week 13, Day 1 Week 19
Baseline, Day 1 Week1, Day 1 Week 13, Day 1 Week 19

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Study Chair: Luis E. Raez, MD, FACP, University of Miami Sylvester Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Estimate)

December 15, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20020225
  • SCCC-2002041 (Other Identifier: UM/Sylvester Comprehensive Cancer Canter)
  • WIRB-20050969 (Other Identifier: Western IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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