Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who are undergoing surgery for stage IB, stage II, or stage IIIA non-small cell lung cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of non-small cell lung cancer

• Clinical stage IB-IIIA disease

• Candidate for surgical resection as primary treatment for tumor

• Surgically resectable tumor ≥ 2.0 cm in diameter

• No brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Platelet count ≥ 100,000/mm^3

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Hematocrit ≥ 30%

Hepatic

• Hepatitis B surface antigen negative*

• Hepatitis B core antigen negative*

• Hepatitis C virus negative*

• Bilirubin ≤ 2.0 mg/dL

• AST and ALT ≤ 2 times upper limit of normal NOTE: *Screening performed only if liver enzymes are elevated

Renal

• Creatinine ≤ 2.2 mg/dL

• BUN ≤ 40 mg/dL

Pulmonary

• FEV_1 > 2.0 L (pre-resection) OR

• Predicted post-resection FEV_1 > 1.0 L

• No more than 2 chronic obstructive pulmonary disease exacerbations requiring > 2 weeks of oral steroids and/or hospitalization within the past year

Immunologic

• Purified protein derivative (PPD) skin test negative

• HIV-1 and HIV-2 negative

• No acute infection, including any acute viral, bacterial, or fungal infection requiring specific therapy within the past 7 days

• No allergy to study agents

• No known autoimmune or collagen vascular disorder

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No underlying condition that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent anti-tumor necrosis factor agents

Chemotherapy

• Standard adjuvant chemotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine

• No concurrent cyclophosphamide

Endocrine therapy

• No concurrent high-dose corticosteroids (e.g., > 10 mg of prednisone)

• Concurrent corticosteroids for minor breathing exacerbations allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period

• No concurrent corticosteroids within 48 hours before or after study vaccine administration

Radiotherapy

• Standard adjuvant radiotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine

Surgery

• No prior organ allograft

Other

• No concurrent antihistamines within 48 hours before or after study vaccine administration

• No concurrent cimetidine or other H2 blockers within 48 hours before or after study vaccine administration

• Concurrent antibiotics for minor infection allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period

• No concurrent cyclosporine

• No concurrent azathioprine

• No other concurrent drugs known to significantly alter immune function

• No concurrent cytotoxic therapy

• No concurrent participation in another clinical trial involving experimental therapy

• No other concurrent anticancer therapy