NCT00098917

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2004

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2005

Completed
Last Updated

January 28, 2008

Status Verified

April 1, 2007

First QC Date

December 8, 2004

Last Update Submit

January 24, 2008

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancer

Interventions

autologous tumor cell vaccineDRUG
therapeutic autologous dendritic cellsDRUG
adjuvant therapyPROCEDURE
biological therapyPROCEDURE
conventional surgeryPROCEDURE
surgeryPROCEDURE
tumor cell derivative vaccinePROCEDURE
vaccine therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

FANG vaccineChemotherapy, AdjuvantBiological TherapySurgical Procedures, OperativeImmunotherapy, Active

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyImmunizationImmunotherapyImmunomodulationImmunologic TechniquesInvestigative Techniques

Study Officials

  • Michael D. Roth, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2004

First Posted

December 9, 2004

Study Start

February 1, 2005

Last Updated

January 28, 2008

Record last verified: 2007-04

Locations

US(1)