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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006470 |
Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these two treatments may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with radiation therapy in treating patients who have stage II or stage IIIA non-small cell lung cancer that has been completely removed in surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: monoclonal antibody 11D10 anti-idiotype vaccine Biological: monoclonal antibody 3H1 anti-idiotype vaccine Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Postoperative Adjuvant Immunotherapy and Radiation in Patients With Completely Resected Stage II and Stage IIIA Non-Small Cell Lung Cancer |
| Study Start Date: | March 2001 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive monoclonal antibody 11D10 anti-idiotype vaccine and monoclonal antibody 3H1 anti-idiotype vaccine intracutaneously in separate sites once weekly for 3 weeks beginning 2-7 weeks (no later than 49 days) after surgery and then subcutaneously once monthly for 2 years regardless of disease progression. Beginning no more than 1 week after the third postoperative vaccination, all patients undergo radiotherapy 5 days a week for 5-6 weeks. Patients with extracapsular nodal metastases or T3 lesions also undergo 6 additional radiotherapy boosts.
Patients are followed at 4-6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage II or IIIA non-small cell lung cancer
No more than 7 weeks since prior surgery (lobectomy, sleeve resection, bilobectomy, or pneumonectomy)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 237 Study Locations| Study Chair: | Benjamin Movsas, MD | Fox Chase Cancer Center |
More Information
| Study ID Numbers: | CDR0000068293, RTOG-9909 |
| Study First Received: | November 6, 2000 |
| Last Updated: | July 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006470 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II non-small cell lung cancer stage IIIA non-small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Immunologic Factors Immunoglobulin Idiotypes Physiological Effects of Drugs Pharmacologic Actions Carcinoma Antibodies, Monoclonal |
Neoplasms Antibodies Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |