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

Lung Cancer Clinical Trial

Official title:

Phase II Trial of Individualized Mutant p53 Peptide-Pulsed Cultured Autologous Dendritic Cells in the Adjuvant Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer After Standard Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00019929
• Other study ID #: CDR0000067284
• Secondary ID: NCI-99-C-0142VU-
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: June 18, 2013
• Start date: August 2000
• Est. completion date: December 2005

Study information

• Verified date: November 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00001829

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• mutant p53 peptide pulsed dendritic cell vaccine

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival by CTEP CTC v2.x			No
Primary	Overall survival by CTEP CTC v2.x			No
Primary	Toxicity by CTEP CTC v2.x			Yes
Secondary	Immunological response by ELISPOT before and 2 weeks after last vaccine			No