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CompletedNCT00006352Updated Jul 18, 2012

Monoclonal Antibody Therapy Plus BCG in Treating Patients With Limited-Stage Small Cell Lung Cancer

A Phase 3 interventional study of BCG vaccine and monoclonal antibody BEC2 in Lung Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-18.

Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
453
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. BCG may activate the immune system to kill tumor cells. Combining monoclonal antibody therapy with BCG may kill more tumor cells. It is not yet known if monoclonal antibody therapy plus BCG is an effective treatment for limited-stage small cell lung cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of monoclonal antibody therapy plus BCG in treating patients who have limited-stage small cell lung cancer.

Read the detailed description

OBJECTIVES:

  • Determine the impact of vaccination with adjuvant BCG and monoclonal antibody BEC2 on the survival of patients with limited stage small cell lung cancer.
  • Determine the progression free survival in these patients after receiving this treatment regimen.
  • Determine the safety of this treatment regimen in these patients.
  • Assess the quality of life in these patients treated with this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, Karnofsky performance status (60-70% vs 80-100%), and response to first line combined modality treatment (complete remission vs partial remission). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive vaccination with BCG and monoclonal antibody BEC2 intradermally on day 1 of weeks 0, 2, 4, 6, and 10 in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive no further therapy. Quality of life is assessed at baseline; at weeks 6, 12, and 24; and every 6 months thereafter until disease progression.

Patients are followed at 6 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 570 patients (285 per treatment arm) will be accrued for this study within 2 years.

02

Conditions studied

  • Lung Cancer

Keywords

  • limited stage small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's enrollment of 453 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)

    • Completed first line combination treatment consisting of at least a 2 drug chemotherapy regimen (4 to 6 courses) and a chest radiotherapy regimen

      • Must have achieved clinical response (complete or partial) with no evidence of progression or relapse

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 3,000/mm\^3
  • Platelet count greater than 100,000/mm\^3

Hepatic:

  • AST less than 1.5 times upper limit of normal
  • No hepatitis B

Renal:

  • Not specified

Other:

  • No history of tuberculosis
  • Purified Protein Derivative negative to at least 5 IU
  • HIV negative
  • No severe active infection
  • No active infections requiring systemic antibiotics, antiviral, or antifungal treatments
  • No serious unstable chronic illness
  • No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • No prior therapy with mouse proteins
  • No other concurrent immunotherapy before first disease progression

Chemotherapy:

  • See Disease Characteristics
  • No concurrent chemotherapy before first disease progression

Endocrine therapy:

  • No concurrent systemic or chronic corticosteroids

Radiotherapy:

  • See Disease Characteristics
  • No prior radiation to spleen
  • No concurrent radiotherapy before first disease progression

Surgery:

  • No prior surgery for SCLC
  • No prior splenectomy

Other:

  • At least 4 weeks since prior combination therapy
  • No prior second line therapy for SCLC
  • At least 4 weeks since other prior investigational agent
  • No concurrent systemic antihistamines or nonsteroidal antiinflammatory drugs
  • No concurrent immunosuppressant therapy before first disease progression
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Enrollment
453 participants (actual)

Interventions

  • BiologicalBCG vaccine
  • Biologicalmonoclonal antibody BEC2
06

Study locations

1 site
  • Vrije Universiteit Medisch Centrum
    Amsterdam, 1001HV, Netherlands
07

References and documents

Publications

  • Giaccone G, Debruyne C, Felip E, Chapman PB, Grant SC, Millward M, Thiberville L, D'addario G, Coens C, Rome LS, Zatloukal P, Masso O, Legrand C. Phase III study of adjuvant vaccination with Bec2/bacille Calmette-Guerin in responding patients with limited-disease small-cell lung cancer (European Organisation for Research and Treatment of Cancer 08971-08971B; Silva Study). J Clin Oncol. 2005 Oct 1;23(28):6854-64. doi: 10.1200/JCO.2005.17.186. PubMed 16192577 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00006352
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Responsible party
Sponsor
First posted
Jul 28, 2003
Start date
Sep 1999
Primary completion
Oct 2002
Last update
Jul 18, 2012

Study contacts

Giuseppe Giaccone, MD, PhD
study chair · Free University Medical Center
View the source record on ClinicalTrials.gov ↗

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