Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

NCT ID: NCT00019929

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2005-12-31

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This phase II trial is studying vaccine therapy given after standard therapy to see how well it works in treating patients with stage III non-small cell lung cancer.

Detailed Description

OBJECTIVES:

• Determine the overall survival in patients with locally advanced non-small cell lung cancer immunized with adjuvant mutant p53 peptide-pulsed autologous dendritic cells after standard therapy.
• Assess the safety and immunological efficacy of this regimen in terms of inducing or boosting a mutant p53-specific immune response in this patient population.

OUTLINE: Patients undergo p53 gene mutation analysis. Patients without a suitable gene mutation receive no vaccination. Patients with a suitable p53 gene mutation receive mutant p53 peptide-pulsed autologous dendritic cells IV over 1-2 minutes weekly for 5 weeks. Patients achieving an immune response with no evidence of progressive disease may receive additional vaccinations every 2 months for a maximum of 10 immunizations.

Patients are followed for 5 years.

PROJECTED ACCRUAL: Approximately 120 patients (40 on the vaccination arm) will be accrued for this study.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

mutant p53 peptide pulsed dendritic cell vaccine

Intervention Type: BIOLOGICAL

adjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC) with one of the following p53 mutations:

• Point mutation altering the protein sequence
• Frame-shift mutation with the generation of a novel sequence
• No significant pleural effusions visible on plain chest radiography
• Must have completed or plan to undergo curative intent therapy for NSCLC

• At least 2 courses of neoadjuvant chemotherapy for patients with known N2 or N3 resectable disease OR
• At least 55 Gy radiotherapy with concurrent or sequential chemotherapy for patients with unresectable disease
• Patients with incidental N2 or N3 disease at time of surgery may receive optional adjuvant chemotherapy and radiotherapy

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Lymphocyte count greater than 475/mm^3
• Granulocyte count greater than 1,000/mm^3
• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL
• SGOT less than 3 times normal
• Albumin at least 3.0 g/dL
• No signs of acute hepatitis B infection

• Hepatitis B surface antigen positive allowed provided there are no signs of chronic active hepatitis
• No prior hepatitis C infection

Renal:

• Creatinine less than 2.5 mg/dL
• Calcium less than 11.0 mg/dL (corrected for albumin)

Cardiovascular:

• No myocardial infarction or significant ventricular arrhythmias within the past 6 months

Other:

• No other malignancy within the past 5 years unless curatively treated and probability of recurrence is less than 5%
• HIV negative
• No psychiatric or other condition that would preclude study
• No serious ongoing infection
• No other serious medical condition that would limit life expectancy to less than 2 years
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy and no anticipated need for chemotherapy for at least 2 months after vaccinations

Endocrine therapy:

• At least 4 weeks since prior supraphysiologic steroids and no anticipated need for steroid therapy for at least 2 months after vaccinations

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and no anticipated need for radiotherapy for at least 2 months after vaccinations

Surgery:

• See Disease Characteristics

Other:

• No influenza vaccination if egg allergy present
• At least 4 weeks and no greater than 24 weeks since completion of all prior modalities for primary therapy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Jay A. Berzofsky, MD, PhD

Role: STUDY_CHAIR

NCI - Vaccine Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

References

Read EJ, Carter CS, Lee J, et al.: Clinical scale preparation of antigen-pulsed mature autologous dendritic cells for tumor-specific immunotherapy. [Abstract] ISHAGE 2001 Seventh Annual Symposium A-100, 2001.

Reference Type: BACKGROUND

Other Identifiers

NCI-99-C-0142

Identifier Type: -

Identifier Source: secondary_id

VU-VCC-THO-9814

Identifier Type: -

Identifier Source: secondary_id

NCI-T96-0045

Identifier Type: -

Identifier Source: secondary_id

CDR0000067284

Identifier Type: -

Identifier Source: org_study_id

NCT00001829

Identifier Type: -

Identifier Source: nct_alias