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

Phase 3
18 Years
Not Enrolling
Lung Cancer

Thank you

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: I. Determine the impact of adjuvant monoclonal antibody BEC2 and BCG on survival
of patients with limited stage small cell lung cancer. II. Determine the safety of this
regimen in these patients. III. Determine progression-free survival and quality of life of
these patients treated with this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, Karnofsky performance status (60-70% vs 80-100%), and response to first-line
combined modality treatment (complete vs partial). Within 3-7 weeks after completion of
prior induction chemoradiotherapy, responding patients are randomized to 1 of 2 treatment
arms. Arm I: Patients receive best supportive care and are observed until disease
progression is documented. Arm II: Patients receive adjuvant monoclonal antibody BEC2 and
BCG intradermally on day 1 of weeks 0, 2, 4, 6, and 10. Treatment consists of 5 vaccinations
over a period of 10 to 12 weeks in the absence of unacceptable toxicity or disease
progression. Quality of life is assessed at baseline, at weeks 6, 12, and 24, and then every
6 months thereafter. Patients are followed every 3 months.

PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study within 4 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven limited stage small cell
lung cancer (SCLC) Must have completed adequate first-line combined modality treatment
comprising at least 4-6 courses of a 2-drug chemotherapy regimen and chest radiotherapy No
evidence of disease progression or relapse Disease response (complete or partial) after

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: WBC greater that 3,000/mm3 Platelet count greater
than 100,000/mm3 Hepatic: AST less than 1.5 times upper limit of normal Hepatitis B
negative Renal: Not specified Cardiovascular: Adequate cardiac function Other: HIV
negative Not pregnant or nursing Fertile patients must use effective contraception No
prior malignancy within 5 years except adequately treated nonmelanomatous skin cancer or
carcinoma in situ of the cervix No history of tuberculosis No grade 3 local skin toxicity
reaction (ulceration) to 5 IU or greater of PPD test No active infections requiring
systemic antibiotics, antiviral, or antifungal treatments No serious unstable chronic
illnesses No psychological, familial, sociological, or geographical condition that would
preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy with proteins of murine
origin At least one month since prior immunotherapy No other concurrent immunotherapy
Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: No
concurrent chronic use of systemic corticosteroids Radiotherapy: See Disease
Characteristics No concurrent radiotherapy including prophylactic cranial irradiation No
prior spleen radiotherapy Surgery: No prior surgery for SCLC No prior splenectomy Other:
No prior second-line therapy for SCLC At least one month since prior investigational
agents No concurrent chronic use of systemic antihistamines or nonsteroidal
anti-inflammatory drugs No concurrent immunosuppressive therapy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Giuseppe Giaccone, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Free University Medical Center


United States: Federal Government

Study ID:




Start Date:

March 1998

Completion Date:

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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