- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00098917
Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
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
Conditions
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
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael D. Roth, MD, Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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