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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
autologous tumor cell vaccine
therapeutic autologous dendritic cells
adjuvant therapy
biological therapy
conventional surgery
surgery
tumor cell derivative vaccine
vaccine therapy
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 8, 2004
Last Updated
January 24, 2008
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00098917
Brief Title
Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
autologous tumor cell vaccine
Intervention Type
Drug
Intervention Name(s)
therapeutic autologous dendritic cells
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
biological therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Type
Procedure
Intervention Name(s)
tumor cell derivative vaccine
Intervention Type
Procedure
Intervention Name(s)
vaccine therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D. Roth, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

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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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