A Phase II Trial of Patients With Limited Stage Small Cell Lung Cancer Treated With Thoracic Radiation Therapy and Chemotherapy With Cisplatin/Etoposide Followed by Cisplatin/Etoposide and Anti-Idiotype Monoclonal Antibody Vaccines
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 9
- Locations
- 100
- Primary Endpoint
- overall survival
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Combining chemotherapy and radiation therapy with vaccine therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with vaccine therapy in treating patients who have limited-stage small cell lung cancer.
Detailed Description
OBJECTIVES:
- Determine the efficacy of cisplatin, etoposide, and thoracic radiotherapy followed by cisplatin, etoposide, monoclonal antibody 11D10 anti-idiotype vaccine (TriAb), and monoclonal antibody GD2 anti-idiotype vaccine (TriGem), in terms of overall and progression-free survival of patients with limited stage small cell lung cancer.
- Determine the immune response to each of the 2 anti-idiotype vaccines when used in this regimen in these patients.
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Determine the response rates (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Thoracic radiotherapy is administered 5 days a week, beginning on day 1 of chemotherapy, for 5 weeks. Patients then undergo radiotherapy boost for 1.5 weeks.
Patients with stable disease or at least partial response proceed to consolidation therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
cisplatin and etoposide followed by vaccine
standard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine
Intervention: monoclonal antibody 11D10 anti-idiotype vaccine (Biological)
cisplatin and etoposide followed by vaccine
standard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine
Intervention: monoclonal antibody GD2 anti-idiotype vaccine (Biological)
cisplatin and etoposide followed by vaccine
standard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine
Intervention: cisplatin (Drug)
cisplatin and etoposide followed by vaccine
standard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine
Intervention: etoposide (Drug)
cisplatin and etoposide followed by vaccine
standard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine
Intervention: radiation therapy (Radiation)
Outcomes
Primary Outcomes
overall survival
Time Frame: up to 5 years
time from date of registration to date of death
Secondary Outcomes
- response(25 weeks)
- toxicity assessment(22 weeks)
- immune response(at Week 10)