Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Combining vaccine therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by adenovirus p53 vaccine therapy in treating patients who have extensive-stage small cell lung cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Treatments: Carboplatin; Etoposide; Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed small cell lung cancer

• Extensive stage disease

• Measurable disease

• No uncontrolled central nervous system (CNS) metastasis

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

• Not specified

Hematopoietic

• White blood count (WBC) greater than 3,000/mm^3

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

• Hematocrit greater than 25%

Hepatic

• Bilirubin less than 2.0 mg/dL

Renal

• Creatinine less than 2.0 mg/dL

Immunologic

• HIV negative

• No serious ongoing infection

• No pre-existing immunodeficiency

• No known pre-existing autoimmune disorder

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• At least 4 weeks since prior steroids (before vaccination)

• No concurrent chronic steroids (during vaccination)

Radiotherapy

• At least 2 weeks since prior radiotherapy (before vaccination)

Surgery

• Not specified