Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
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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) |
| Estimated Enrollment: | 15 |
| Study Start Date: | February 2005 |
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 |
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| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| 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 May 23, 2013