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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael D. Roth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

Unspecified

Study ID:

CDR0000396774

NCT ID:

NCT00098917

Start Date:

February 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781