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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014