search
Back to results

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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
mutant p53 peptide pulsed dendritic cell vaccine
adjuvant therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • Vanderbilt-Ingram Cancer Center

Outcomes

Primary Outcome Measures

Disease-free survival by CTEP CTC v2.x
Overall survival by CTEP CTC v2.x
Toxicity by CTEP CTC v2.x

Secondary Outcome Measures

Immunological response by ELISPOT before and 2 weeks after last vaccine

Full Information

First Posted
July 11, 2001
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00019929
Brief Title
Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
mutant p53 peptide pulsed dendritic cell vaccine
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Disease-free survival by CTEP CTC v2.x
Title
Overall survival by CTEP CTC v2.x
Title
Toxicity by CTEP CTC v2.x
Secondary Outcome Measure Information:
Title
Immunological response by ELISPOT before and 2 weeks after last vaccine

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay A. Berzofsky, MD, PhD
Organizational Affiliation
NCI - Vaccine Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs