NCT00019929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2000

Typical duration for phase_2 lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

June 20, 2013

Status Verified

November 1, 2005

First QC Date

July 11, 2001

Last Update Submit

June 18, 2013

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (3)

  • Disease-free survival by CTEP CTC v2.x

  • Overall survival by CTEP CTC v2.x

  • Toxicity by CTEP CTC v2.x

Secondary Outcomes (1)

  • Immunological response by ELISPOT before and 2 weeks after last vaccine

Interventions

mutant p53 peptide pulsed dendritic cell vaccineBIOLOGICAL
adjuvant therapyPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related 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.

    BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Jay A. Berzofsky, MD, PhD

    NCI - Vaccine Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

August 1, 2000

Study Completion

December 1, 2005

Last Updated

June 20, 2013

Record last verified: 2005-11

Locations

US(2)