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

Edward Hirschowitz

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Biological: autologous dendritic cell cancer vaccine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00103116

R21CA091624 (U.S. NIH Grant/Contract)

UKMC-IRB-0391-F2R (Other Identifier)

CDR0000410830

UKMC-CTRF-G-01-009 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the immunologic effects of adjuvant vaccine therapy comprising autologous dendritic cells loaded with allogeneic non-small cell lung cancer (NSCLC) cells in patients with unresectable stage IIIA or IIIB, or resected stage I-IIIB NSCLC.
• Determine the potential clinical efficacy of this vaccine in these patients.

OUTLINE: This is an open-label study. Patients are stratified according to type of prior primary therapy (surgical vs nonsurgical).

Patients undergo leukapheresis over 3-4 hours to harvest mononuclear cells for the production of dendritic cells (DC). DC are then pulsed with allogeneic non-small cell lung cancer cells to produce an autologous dendritic cell vaccine. Patients receive vaccine intradermally once a month for 2 months in the absence of disease recurrence or unacceptable toxicity.

Patients are followed monthly for 4 months, every 6 months for 2 years, and then periodically thereafter.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 3 years.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Autologous dendritic cell cancer vaccine

Experimental group

Description:

Open label nonrandomized

Treatment:

Biological: autologous dendritic cell cancer vaccine