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

Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00098917
• Other study ID #: CDR0000396774
• Secondary ID: UCLA-0406031-01N
• Status: Terminated
• Phase: Phase 1
• First received: December 8, 2004
• Last updated: January 24, 2008
• Start date: February 2005

Study information

• Verified date: April 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• autologous tumor cell vaccine

• therapeutic autologous dendritic cells

Procedure:
• adjuvant therapy

• biological therapy

• conventional surgery

• surgery

• tumor cell derivative vaccine

• vaccine therapy

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,