search
Back to results

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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
BCG vaccine
monoclonal antibody BEC2
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring limited stage small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vrije Universiteit Medisch Centrum

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 4, 2000
Last Updated
July 17, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
search

1. Study Identification

Unique Protocol Identification Number
NCT00006352
Brief Title
Monoclonal Antibody Therapy Plus BCG in Treating Patients With Limited-Stage Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
limited stage small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
453 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
BCG vaccine
Intervention Type
Biological
Intervention Name(s)
monoclonal antibody BEC2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Giaccone, MD, PhD
Organizational Affiliation
Free University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1001HV
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
16192577
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs