Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006035
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2000-07-05
Brief Title:
Bleomycin With or Without Electroporation Therapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open Label Lesion Controlled Study of Electroporation Therapy EPT for the Treatment of Cutaneous Metastatic Melanoma Using the Genetronics Inc Medpulser System and Bleomycin
Status:
UNKNOWN
Status Verified Date:
2000-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Electroporation therapy may enhance the ability of chemotherapy drugs to enter tumor cells Combining chemotherapy with electroporation therapy may kill more tumor cells
PURPOSE Randomized phase I trial to compare the effectiveness of bleomycin with or without electroporation therapy in treating patients who have stage III or stage IV melanoma
PURPOSE Randomized phase I trial to compare the effectiveness of bleomycin with or without electroporation therapy in treating patients who have stage III or stage IV melanoma
Detailed Description:
OBJECTIVES I Compare the objective tumor response rate of patients with stage III or IV melanoma when treated with intratumoral bleomycin with or without electroporation therapy II Determine the safety of electroporation therapy in these patients III Compare the time to heal with these treatments in these patients IV Compare the duration of lesion response with these treatments in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive bleomycin intratumorally on day 1 Arm II Patients receive bleomycin intratumorally followed by electroporation therapy intratumorally on day 1 Treatment continues every 4 weeks in the absence of unacceptable toxicity Patients in arm I with progressive disease after 1 course of treatment may be crossed over to arm II Patients are followed at 4 and 6 months after final treatment
PROJECTED ACCRUAL A total of 20 patients 10 per treatment arm will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive bleomycin intratumorally on day 1 Arm II Patients receive bleomycin intratumorally followed by electroporation therapy intratumorally on day 1 Treatment continues every 4 weeks in the absence of unacceptable toxicity Patients in arm I with progressive disease after 1 course of treatment may be crossed over to arm II Patients are followed at 4 and 6 months after final treatment
PROJECTED ACCRUAL A total of 20 patients 10 per treatment arm 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 |
|---|---|---|---|
| NCI-G00-1811 | None | None | None |
| MCC-11883 | None | None | None |
| GENETR-EPT-9706001 | None | None | None |
| MCC-IRB-5219 | None | None | None |