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

• ClinicalTrials.gov Identifier: NCT00098917
• Recruitment Status: Terminated
• First Posted: December 9, 2004
• Last Update Posted: January 28, 2008
• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: December 8, 2004
• First Posted Date: December 9, 2004
• Last Update Posted Date: January 28, 2008
• Study Start Date: February 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)

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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Primary Purpose: Treatment
• Condition: Lung Cancer

Intervention

• 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

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Enrollment (submitted: November 8, 2006): 15
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00098917
• Other Study ID Numbers: CDR0000396774; UCLA-0406031-01; NCI-6766
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Michael D. Roth, MD; Jonsson Comprehensive Cancer Center

• PRS Account: National Cancer Institute (NCI)
• Verification Date: April 2007