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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


Phase 2
N/A
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Disease-free survival by CTEP CTC v2.x

Safety Issue:

No

Principal Investigator

Jay A. Berzofsky, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Vaccine Branch

Authority:

United States: Federal Government

Study ID:

CDR0000067284

NCT ID:

NCT00019929

Start Date:

August 2000

Completion Date:

December 2005

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182