Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003263
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
1999-11-01
Brief Title:
Cisplatin Interferon Alfa Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase I Combined Modality Protocol for Malignant Mesothelioma Cisplatin rIFN-alpha-2b Followed by Surgical Resection Debulking and Post-Op Concurrent Chemoradiotherapy With Cisplatin - rIFN-alpha-2b
Status:
COMPLETED
Status Verified Date:
2013-04
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 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 Interferon alfa may interfere with the growth of cancer cells Combining chemotherapy radiation therapy and interferon alfa may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of cisplatin plus interferon alfa followed by surgery and interferon alfa plus radiation therapy in treating patients with malignant pleural mesothelioma
PURPOSE Phase I trial to study the effectiveness of cisplatin plus interferon alfa followed by surgery and interferon alfa plus radiation therapy in treating patients with malignant pleural mesothelioma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD of neoadjuvant interferon alfa 2b IFN-A2b administered with cisplatin in patients with malignant pleural mesothelioma II Determine the MTD of IFN-A2b administered with radiation therapy and cisplatin after surgery in these patients III Determine the response rate and toxicity of induction therapy with IFN-A2b and cisplatin in these patients IV Determine the toxicity of concurrent radiation therapy cisplatin and IFN-A2b after surgery in these patients V Determine the local control rate freedom from progression median survival and long term survival of these patients after combined modality therapy
OUTLINE This is a dose escalation study Patients receive induction therapy consisting of cisplatin IV weekly and interferon alfa 2b IFN-A2b subcutaneously three times a week for 6 weeks Patients who experience at least 25 tumor shrinkage receive another 4 weeks of therapy Patients then undergo debulking surgery to remove all gross tumor if possible If this resection is performed then patients begin radiation therapy 2-6 weeks after surgery Patients with unresectable tumors begin radiation therapy 2-4 weeks after the last course of induction chemotherapy Patients undergo radiation therapy 5 days a week for 6 weeks Concurrently patients receive cisplatin IV weekly and IFN-A2b subcutaneously three times a week Cohorts of 4 patients each receive escalated doses of IFN-A2b during induction chemotherapy Once the maximum tolerated dose MTD of IFN-A2b is established one dose level below this dose is used for the beginning doses of IFN-A2b during adjuvant chemotherapy If no unacceptable toxic effects occur then the dose of IFN-A2b is escalated to the induction MTD Patients are followed at 3-6 weeks after completing radiochemotherapy then every 3 months thereafter
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 2-3 years
OUTLINE This is a dose escalation study Patients receive induction therapy consisting of cisplatin IV weekly and interferon alfa 2b IFN-A2b subcutaneously three times a week for 6 weeks Patients who experience at least 25 tumor shrinkage receive another 4 weeks of therapy Patients then undergo debulking surgery to remove all gross tumor if possible If this resection is performed then patients begin radiation therapy 2-6 weeks after surgery Patients with unresectable tumors begin radiation therapy 2-4 weeks after the last course of induction chemotherapy Patients undergo radiation therapy 5 days a week for 6 weeks Concurrently patients receive cisplatin IV weekly and IFN-A2b subcutaneously three times a week Cohorts of 4 patients each receive escalated doses of IFN-A2b during induction chemotherapy Once the maximum tolerated dose MTD of IFN-A2b is established one dose level below this dose is used for the beginning doses of IFN-A2b during adjuvant chemotherapy If no unacceptable toxic effects occur then the dose of IFN-A2b is escalated to the induction MTD Patients are followed at 3-6 weeks after completing radiochemotherapy then every 3 months thereafter
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 2-3 years
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 |
|---|---|---|---|
| NCI-G98-1401 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |
| FCCC-96087 | None | None | None |