Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098917
First received: December 8, 2004
Last updated: January 24, 2008
Last verified: April 2007
  Purpose

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who are undergoing surgery for stage IB, stage II, or stage IIIA non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: autologous tumor cell vaccine
Drug: therapeutic autologous dendritic cells
Procedure: adjuvant therapy
Procedure: biological therapy
Procedure: conventional surgery
Procedure: surgery
Procedure: tumor cell derivative vaccine
Procedure: vaccine therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial of Mature Autologous Dendritic Cells Loaded With Irradiated Autologous Tumor Cells for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 15
Study Start Date: February 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of adjuvant autologous dendritic cells loaded with irradiated autologous tumor cells in patients with stage IB-IIIA non-small cell lung cancer undergoing resection.
  • Determine the safety and tolerability of this vaccine in these patients.

Secondary

  • Determine the feasibility of this vaccine in these patients.
  • Determine vaccine-specific and antitumor immunity in patients treated with this vaccine.

OUTLINE: This is a dose-escalation study.

Patients undergo leukaphersis to isolate peripheral blood mononuclear cells (PBMC). PBMC are expanded ex vivo to generate monocyte-derived dendritic cells (DC). Autologous tumor cells are harvested and purified at the time of surgical resection. DC are then loaded with irradiated autologous tumor cells.

Within 4-8 weeks after surgical resection, patients receive autologous DC loaded with irradiated autologous tumor cells intradermally on approximately days 1, 30, and 60 in the absence of unacceptable toxicity.

Cohorts of 6-9 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. If 2 of 9 patients in the first cohort experience dose-limiting toxicity, that dose level is considered the MTD.

Patients are followed at approximately 1 and 4 months, and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study within 18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of non-small cell lung cancer

    • Clinical stage IB-IIIA disease
  • Candidate for surgical resection as primary treatment for tumor

    • Surgically resectable tumor ≥ 2.0 cm in diameter
  • No brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Hematocrit ≥ 30%

Hepatic

  • Hepatitis B surface antigen negative*
  • Hepatitis B core antigen negative*
  • Hepatitis C virus negative*
  • Bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2 times upper limit of normal NOTE: *Screening performed only if liver enzymes are elevated

Renal

  • Creatinine ≤ 2.2 mg/dL
  • BUN ≤ 40 mg/dL

Pulmonary

  • FEV_1 > 2.0 L (pre-resection) OR
  • Predicted post-resection FEV_1 > 1.0 L
  • No more than 2 chronic obstructive pulmonary disease exacerbations requiring > 2 weeks of oral steroids and/or hospitalization within the past year

Immunologic

  • Purified protein derivative (PPD) skin test negative
  • HIV-1 and HIV-2 negative
  • No acute infection, including any acute viral, bacterial, or fungal infection requiring specific therapy within the past 7 days
  • No allergy to study agents
  • No known autoimmune or collagen vascular disorder

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No underlying condition that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent anti-tumor necrosis factor agents

Chemotherapy

  • Standard adjuvant chemotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine
  • No concurrent cyclophosphamide

Endocrine therapy

  • No concurrent high-dose corticosteroids (e.g., > 10 mg of prednisone)
  • Concurrent corticosteroids for minor breathing exacerbations allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period
  • No concurrent corticosteroids within 48 hours before or after study vaccine administration

Radiotherapy

  • Standard adjuvant radiotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine

Surgery

  • No prior organ allograft

Other

  • No concurrent antihistamines within 48 hours before or after study vaccine administration
  • No concurrent cimetidine or other H2 blockers within 48 hours before or after study vaccine administration
  • Concurrent antibiotics for minor infection allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period
  • No concurrent cyclosporine
  • No concurrent azathioprine
  • No other concurrent drugs known to significantly alter immune function
  • No concurrent cytotoxic therapy
  • No concurrent participation in another clinical trial involving experimental therapy
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098917

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Michael D. Roth, MD Jonsson Comprehensive Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00098917     History of Changes
Other Study ID Numbers: CDR0000396774, UCLA-0406031-01, NCI-6766
Study First Received: December 8, 2004
Last Updated: January 24, 2008
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014