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

January 24, 2008 updated by: Jonsson Comprehensive Cancer Center

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Michael D. Roth, MD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Registration Dates

First Submitted

December 8, 2004

First Submitted That Met QC Criteria

December 8, 2004

First Posted (Estimate)

December 9, 2004

Study Record Updates

Last Update Posted (Estimate)

January 28, 2008

Last Update Submitted That Met QC Criteria

January 24, 2008

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000396774
  • UCLA-0406031-01
  • NCI-6766

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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