Lung Cancer Clinical Trial
Official title:
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
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.
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.
- Consolidation therapy (begins within 3-5 weeks of the last dose of induction
chemotherapy or radiotherapy): Patients receive cisplatin IV over 1 hour on day 1 and
etoposide IV over 1 hour on days 1-3 of weeks 11 and 14. Patients also receive
monoclonal antibody 11D10 anti-idiotype vaccine (TriAb) and monoclonal antibody GD2
anti-idiotype vaccine (TriGem) intradermally on day 1 of weeks 11, 13, 15, and 17 (4
injections) and then monthly subcutaneously for 2 years. Treatment continues in the
absence of disease progression or unacceptable toxicity.
Patients who achieve complete response after consolidation chemotherapy undergo cranial
radiotherapy 5 days a week for 3 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18 months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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