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Lung CancerPhase 3NCT00006352

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

A Phase 3 study testing BCG vaccine and monoclonal antibody BEC2 in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
BCG vaccine and monoclonal antibody BEC2
Type of treatment
Vaccines
How many people
453 participants
Where
1 siteNetherlands
Study dates
Sep 1999to Oct 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1001HV

Other trials in Netherlands

About this study

Official title: The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG

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.

Conditions
Lung Cancer
Being tested
BCG vaccine, monoclonal antibody BEC2
Keywords
limited stage small cell lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCG vaccineBiological

  • monoclonal antibody BEC2Biological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2003 (estimated)
  2. Study startSep 1999
  3. Primary completionOct 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006352
Sponsor's protocol ID
EORTC-08971B
Other IDs
EORTC-08971B
Status last verified
Jul 2012
First submitted
4 Oct 2000
Last updated
18 Jul 2012
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCG vaccine and monoclonal antibody BEC2 in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.

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