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.
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
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.
- First posted9 Dec 2004 (estimated)
- Study startFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Michael D. Roth, MD, Principal investigator, Jonsson Comprehensive Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00098917
- Acronym / sponsor ID
- CDR0000396774
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2005
- First posted
- 9 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous tumor cell vaccine | Drug | – |
| therapeutic autologous dendritic cells | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| biological therapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| surgery | Procedure or surgery | – |
| tumor cell derivative vaccine | Procedure or surgery | – |
| vaccine therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D. Roth, MD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.