The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG
18 Years
N/A
Both
Lung Cancer
Trial Information
The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Giuseppe Giaccone, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Free University Medical Center
Authority:
United States: Federal Government
Study ID:
EORTC-08971B
NCT ID:
NCT00006352
Start Date:
September 1999
Completion Date:
Related Keywords:
- Lung Cancer
- limited stage small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|
