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CompletedPhase 2NCT00103116
Official study title

Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer

Study summary

RATIONALE: Vaccines made from a person's white blood cells and allogeneic tumor cells may make the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedautologous dendritic cell cancer vaccine

The study team can explain what participation involves.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 4, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Edward Hirschowitz

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Edward Hirschowitz
Interventions being studied
Biological: autologous dendritic cell cancer vaccine
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
Early-stage or resectable→Locally advanced→
Treatment approach
Cell or gene therapy→
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
  • DISEASE CHARACTERISTICS:
  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • Meets 1 of the following stage criteria:
  • Completely resected stage I-IIIB disease
  • Underwent surgical resection \> 4 weeks but ≤ 4 years ago
  • Unresectable stage IIIA or IIIB disease AND previously treated with definitive radiotherapy or chemotherapy \> 6 weeks ago
  • Bronchoalveolar carcinomas allowed
  • Clinically stable disease by chest x-ray or CT scan within the past 6 weeks
  • No progressive disease
  • No malignant pleural or pericardial effusions PATIENT CHARACTERISTICS: Age
  • 18 to 80 Performance status
  • ECOG 0-1 Life expectancy
  • Not specified Hematopoietic
  • Hemoglobin ≥ 9.0 g/dL Hepatic
  • Bilirubin ≤ 2.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • No known history of infectious hepatitis Renal
  • Creatinine ≤ 3 mg/dL
  • Ionized calcium ≥ 0.9 mmol/L (may be replaced) Cardiovascular
  • No known New York Heart Association class III-IV congestive heart failure
  • No hemodynamically significant valvular heart disease
  • No myocardial infarction within the past 6 months
  • No active angina pectoris
  • No uncontrolled ventricular arrhythmia
  • No stroke within the past year
  • No known cerebrovascular disease
  • No other significant cardiac disease by echocardiogram, stress test, or risk assessment by cardiologist (for patients suspected of cardiac disease by history or physical exam) Immunologic
  • No known HIV positivity
  • No other immunosuppressive disorders, including chronic disorders Other
  • Not pregnant
  • Negative pregnancy test
  • Potassium ≥ 3.0 mEq/L (may be replaced)
  • Able to tolerate modest blood volume and electrolyte shifts during leukapheresis
  • No other malignancy PRIOR CONCURRENT THERAPY: Biologic therapy
  • Prior biologic therapy allowed
  • Other concurrent biologic therapy allowed Chemotherapy
  • See Disease Characteristics
  • No concurrent chemotherapy Endocrine therapy
  • No concurrent steroids during and for 16 weeks after study treatment Radiotherapy
  • See Disease Characteristics
  • No concurrent radiotherapy Surgery
  • See Disease Characteristics Other
  • Prior neoadjuvant or adjuvant therapy for surgically resected patients allowed
  • No concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment
  • No concurrent chronic immunosuppressive medications
  • Concurrent cyclooxygenase-2 inhibitors allowed

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

  • Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 4, 2017. Always confirm current availability with the study team.

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