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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00045617 |
Purpose
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.
| Condition | Intervention | Phase |
|
Lung Cancer |
Drug: cisplatin Drug: etoposide Drug: monoclonal antibody 11D10 anti-idiotype vaccine Drug: monoclonal antibody GD2 anti-idiotype vaccine Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Cancer Lung Cancer |
| Drug Information available for: | Etoposide Cisplatin Etoposide phosphate |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| 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 |
| Study Start Date: | January 2003 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations![]() |
Show 100 Study Locations |
| Southwest Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Abdul-Rahman Jazieh, MD, MPH | Barrett Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000256922, SWOG-S0122 |
| First Received: | September 6, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00045617 |
| Health Authority: | United States: Federal Government |
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