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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00019929
Enrollment
Unknown
Registered
2003-01-27
Start date
2000-08-31
Completion date
2005-12-31
Last updated
2013-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

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

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.

Interventions

PROCEDUREadjuvant therapy

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Immunological response by ELISPOT before and 2 weeks after last vaccine

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026