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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00006352
First received: October 4, 2000
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: BCG vaccine
Biological: monoclonal antibody BEC2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 453
Study Start Date: September 1999
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006352

Locations
Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1001HV
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Giuseppe Giaccone, MD, PhD Free University Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00006352     History of Changes
Other Study ID Numbers: EORTC-08971B, EORTC-08971B
Study First Received: October 4, 2000
Last Updated: July 17, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
limited stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014