Ignite Creation Date:
2024-05-05 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00553618
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-10-29
First Post:
2007-11-01
Brief Title:
Adjuvant Combined Interleukin 2 Proleukin and DTIC Dacarbazine in High-risk Melanoma Patients
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Adjuvant Interleukin2 Proleukinand 5-33 Dimethyl-1-Triazeno Imidazole-4-Carboxamide DTIC in Resected High-Risk Primary and Regionally Metastatic Melanoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2021-10
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:
DTIC
Brief Summary:
The purpose of this study is to see if the combination of the two cancer drugs Dacarbazine DTIC and a low-dose of Proleukin IL2 would provide a less toxic and more effective treatment for melanoma than currently available treatments for people with high-risk melanoma Dacarbazine DTIC and Proleukin IL2 are both FDA-approved drugs for the treatment of melanoma
Detailed Description:
The prognosis of patients with malignant melanomas that are greater than 4 mm deep or involve regional lymph nodes is poor even after successful surgical removal The concept of adjuvant therapy for melanoma is derived from the hypothesis that these therapies may kill micro-metastatic seeds of melanoma cells
The rationale for this particular drug combination regimen is that melanoma cells may act as a vaccine from which to generate melanoma-specific T cell expansion by way of IL2 administration In unpublished results forty-two stage II and III melanoma patients were treated with this regimen at the University of Alabama with IRB approval Analysis of relapse free survival and overall survival in patients treated with this combination suggested a small improvement in disease-free survival when compared to historical controls or another study whose patients had similar but not identical staging median follow-up time of 30 months Importantly no unanticipated side effects were observed as a result of the combination of these two drugs both of which are FDA-approved for use in melanoma patients
The rationale for this particular drug combination regimen is that melanoma cells may act as a vaccine from which to generate melanoma-specific T cell expansion by way of IL2 administration In unpublished results forty-two stage II and III melanoma patients were treated with this regimen at the University of Alabama with IRB approval Analysis of relapse free survival and overall survival in patients treated with this combination suggested a small improvement in disease-free survival when compared to historical controls or another study whose patients had similar but not identical staging median follow-up time of 30 months Importantly no unanticipated side effects were observed as a result of the combination of these two drugs both of which are FDA-approved for use in melanoma patients
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