AzTrials
AzTrials

Lung CancerPhase 1NCT00098917

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

A Phase 1 study testing autologous tumor cell vaccine, therapeutic autologous dendritic cells and adjuvant therapy in people with Lung Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
autologous tumor cell vaccine, therapeutic autologous dendritic cells and adjuvant therapy
Type of treatment
Vaccines, Surgery or procedure
How many people
15 participants
Where
1 siteUnited States
Study dates
Feb 2005to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

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)

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.

Read the 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.

Conditions
Lung Cancer
Being tested
autologous tumor cell vaccine, therapeutic autologous dendritic cells, adjuvant therapy, biological therapy, conventional surgery
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • autologous tumor cell vaccineDrug

  • therapeutic autologous dendritic cellsDrug

  • adjuvant therapyProcedure or surgery

  • biological therapyProcedure or surgery

  • conventional surgeryProcedure or surgery

  • surgeryProcedure or surgery

  • tumor cell derivative vaccineProcedure or surgery

  • vaccine therapyProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2004 (estimated)
  2. Study startFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Enrolment
15 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098917
Sponsor's protocol ID
CDR0000396774
Other IDs
UCLA-0406031-01, NCI-6766
Status last verified
Apr 2007
First submitted
8 Dec 2004
Last updated
28 Jan 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing autologous tumor cell vaccine, therapeutic autologous dendritic cells and adjuvant therapy in people with Lung Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2008.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in