Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045617
Status:
TERMINATED
Last Update Posted:
2012-06-13
First Post:
2002-09-06
Brief Title:
S0122 Combination Chemotherapy Radiation Therapy and Vaccine Therapy in Limited-Stage Small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of Patients With Limited Stage Small Cell Lung Cancer Treated With Thoracic Radiation Therapy and Chemotherapy With CisplatinEtoposide Followed by CisplatinEtoposide and Anti-Idiotype Monoclonal Antibody Vaccines
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to lack of drug availability
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Determine the efficacy of cisplatin etoposide and thoracic radiotherapy followed by cisplatin etoposide monoclonal antibody 11D10 anti-idiotype vaccine TriAb and monoclonal antibody GD2 anti-idiotype vaccine TriGem in terms of overall and progression-free survival of patients with limited stage small cell lung cancer
Determine the immune response to each of the 2 anti-idiotype vaccines when used in this regimen in these patients
Determine the qualitative and quantitative toxicity of this regimen in these patients
Determine the response rates confirmed and unconfirmed complete and partial in patients with measurable disease treated with this regimen
OUTLINE This is a multicenter study
Induction therapy Patients receive cisplatin IV over 1 hour on days 1 8 29 and 36 and etoposide IV over 1 hour on days 1-5 and 29-33 Thoracic radiotherapy is administered 5 days a week beginning on day 1 of chemotherapy for 5 weeks Patients then undergo radiotherapy boost for 15 weeks
Patients with stable disease or at least partial response proceed to consolidation therapy
Consolidation therapy begins within 3-5 weeks of the last dose of induction chemotherapy or radiotherapy Patients receive cisplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14 Patients also receive monoclonal antibody 11D10 anti-idiotype vaccine TriAb and monoclonal antibody GD2 anti-idiotype vaccine TriGem intradermally on day 1 of weeks 11 13 15 and 17 4 injections and then monthly subcutaneously for 2 years Treatment continues in the absence of disease progression or unacceptable toxicity
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
Determine the efficacy of cisplatin etoposide and thoracic radiotherapy followed by cisplatin etoposide monoclonal antibody 11D10 anti-idiotype vaccine TriAb and monoclonal antibody GD2 anti-idiotype vaccine TriGem in terms of overall and progression-free survival of patients with limited stage small cell lung cancer
Determine the immune response to each of the 2 anti-idiotype vaccines when used in this regimen in these patients
Determine the qualitative and quantitative toxicity of this regimen in these patients
Determine the response rates confirmed and unconfirmed complete and partial in patients with measurable disease treated with this regimen
OUTLINE This is a multicenter study
Induction therapy Patients receive cisplatin IV over 1 hour on days 1 8 29 and 36 and etoposide IV over 1 hour on days 1-5 and 29-33 Thoracic radiotherapy is administered 5 days a week beginning on day 1 of chemotherapy for 5 weeks Patients then undergo radiotherapy boost for 15 weeks
Patients with stable disease or at least partial response proceed to consolidation therapy
Consolidation therapy begins within 3-5 weeks of the last dose of induction chemotherapy or radiotherapy Patients receive cisplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14 Patients also receive monoclonal antibody 11D10 anti-idiotype vaccine TriAb and monoclonal antibody GD2 anti-idiotype vaccine TriGem intradermally on day 1 of weeks 11 13 15 and 17 4 injections and then monthly subcutaneously for 2 years Treatment continues in the absence of disease progression or unacceptable toxicity
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
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0122 | OTHER | None | None |