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Study 19 of 1191 for search of: | United States, Mississippi |
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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045617 |
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 |
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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 |
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.
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
Study Chair: | Abdul-Rahman Jazieh, MD, MPH | Barrett Cancer Center |
Study ID Numbers: | CDR0000256922, SWOG-S0122 |
Study First Received: | September 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00045617 |
Health Authority: | United States: Federal Government |
limited stage small cell lung cancer |
Thoracic Neoplasms Immunoglobulin Idiotypes Carcinoma, Neuroendocrine Etoposide phosphate Carcinoma Neuroendocrine Tumors Antibodies, Monoclonal Carcinoma, Small Cell Neuroectodermal Tumors Antibodies |
Cisplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Etoposide Immunoglobulins Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Radiation-Sensitizing Agents Immunologic Factors |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Neoplasms, Nerve Tissue Antineoplastic Agents, Phytogenic Pharmacologic Actions |