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CompletedPhase 1NCT00503568
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAd100-gp96Ig-HLA A1

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 15, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Miami

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
University of Miami
Interventions being studied
Biological: Ad100-gp96Ig-HLA A1
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→Recurrent or relapsed→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 15, 2016. Always confirm current availability with the study team.

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