A Phase 2 interventional study of monoclonal antibody 11D10 anti-idiotype vaccine and monoclonal antibody GD2 anti-idiotype vaccine in Lung Cancer, sponsored by SWOG Cancer Research Network. Terminated at 100 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-13.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
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:
OUTLINE: This is a multicenter study.
Patients with stable disease or at least partial response proceed to consolidation therapy.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 9 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
standard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine
Biological: monoclonal antibody 11D10 anti-idiotype vaccine · Biological: monoclonal antibody GD2 anti-idiotype vaccine · Drug: cisplatin · Drug: etoposide · Radiation: radiation therapy
overall survival
time from date of registration to date of death
Time frame: up to 5 years
immune response
T-cell proliferation and HAMA testing
Time frame: at Week 10
toxicity assessment
assessment of qualitative and quantitative toxicities
Time frame: 22 weeks
response
RECIST partial and complete response
Time frame: 25 weeks
This study is terminated, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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SWOG Cancer Research Network