Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006470
Status:
COMPLETED
Last Update Posted:
2013-08-13
First Post:
2000-11-06
Brief Title:
Vaccine Therapy Plus Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer That Has Been Completely Removed in Surgery
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Determine the humoral and T-cell response to adjuvant monoclonal antibody 11D10 anti-idiotype vaccine and monoclonal antibody 3H1 anti-idiotype vaccine with radiotherapy in patients with completely resected stage II or IIIA non-small cell lung cancer
Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients
Determine the progression-free and overall survival of patients treated with this regimen
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
Determine the humoral and T-cell response to adjuvant monoclonal antibody 11D10 anti-idiotype vaccine and monoclonal antibody 3H1 anti-idiotype vaccine with radiotherapy in patients with completely resected stage II or IIIA non-small cell lung cancer
Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients
Determine the progression-free and overall survival of patients treated with this regimen
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068293 | None | None | None |