Ignite Creation Date:
2024-05-05 @ 10:28 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01110226
Status:
TERMINATED
Last Update Posted:
2020-03-17
First Post:
2009-12-14
Brief Title:
Trial Of Cisplatin And KML-001 in Platinum Responsive Malignancies
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Phase I Trial Of Cisplatin And KML-001 In Advanced Non-Small Cell Lung Cancer and Other Platinum Responsive Malignancies
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Toxicity was not felt to be acceptable for further development
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
0805GCC
Brief Summary:
This is a Phase I Clinical Trial Phase I studies are designed to determine the amount of investigational drugs that can be safely tolerated and to define the side effects that limit the dose The drug administered in this study is KML-001 It is a highly soluble orally available arsenic agent It is currently being tested to determine its effects on telomerase activity
In other words the purpose of this research study is to find the highest dose of KML001 that can be given without causing severe side effects when it is combined with a standard commercially available anti-cancer drug called cisplatin
In other words the purpose of this research study is to find the highest dose of KML001 that can be given without causing severe side effects when it is combined with a standard commercially available anti-cancer drug called cisplatin
Detailed Description:
Telomerase is the enzyme synthesizing the specific DNA sequences found at the telomeres in the bodys chromosomes It is thus responsible for maintaining the length of telomeres Telomerase has been detected in human cancer cells and is found to be 10-20 times more active than in normal body cells This provides a selective growth advantage to many types of tumors If telomerase activity was to be turned off then telomeres in cancer cells would shorten just like they do in normal body cells This would prevent the cancer cells from dividing uncontrollably in their early stages of development In the event that a tumor has already thoroughly developed it may be removed and anti-telomerase therapy could be administered to prevent relapse
This study is being offered to patients with advanced cancer which has either no standard therapy or which has progressed after treatment with one or more standard treatments
The primary objective of this study
To determine the maximum tolerated dose of KML001 in combination with cisplatin in patients with advanced malignancy This objective has been met The study will be reopened with expansion cohorts in advanced small cell lung cancer and non-small cell lung cancer to better assess the activity of the combination pending Institutional Review Board IRB approval
Secondary Objectives of the study
To determine the pharmacokinetics of KML001 and cisplatin in this combination To assess the response rate disease-free survival and survival associated with this regimen
To correlate indications of patient benefit response or stable disease with pretreatment specimens
The highest safest doses are determined by increasing the doses of cisplatin and KML001 in successive groups of patients until at least some of them have serious side effects All patients on this study will receive the same dose of cisplatin which is known to have antitumor effects The doses of KML001 will be increased in successive groups of patients It is possible that those entering the study early may receive suboptimal doses of KML001 At the end of the study we hope to determine the appropriate dose of the KML001 in combination with cisplatin learn about its side effects and understand how the body metabolizes the drug
Laboratory data from the University of Maryland Greenebaum Cancer Center UMGCC has demonstrated that the combination of KML001 and cisplatin is synergistic in lung cancer cell lines Cisplatin is the best established agent for the treatment of lung cancer and most treatment regimens have been established with cisplatin or its congener carboplatin This synergism is particularly interesting given that there is an anti-telomere effect for cisplatin
This study is being offered to patients with advanced cancer which has either no standard therapy or which has progressed after treatment with one or more standard treatments
The primary objective of this study
To determine the maximum tolerated dose of KML001 in combination with cisplatin in patients with advanced malignancy This objective has been met The study will be reopened with expansion cohorts in advanced small cell lung cancer and non-small cell lung cancer to better assess the activity of the combination pending Institutional Review Board IRB approval
Secondary Objectives of the study
To determine the pharmacokinetics of KML001 and cisplatin in this combination To assess the response rate disease-free survival and survival associated with this regimen
To correlate indications of patient benefit response or stable disease with pretreatment specimens
The highest safest doses are determined by increasing the doses of cisplatin and KML001 in successive groups of patients until at least some of them have serious side effects All patients on this study will receive the same dose of cisplatin which is known to have antitumor effects The doses of KML001 will be increased in successive groups of patients It is possible that those entering the study early may receive suboptimal doses of KML001 At the end of the study we hope to determine the appropriate dose of the KML001 in combination with cisplatin learn about its side effects and understand how the body metabolizes the drug
Laboratory data from the University of Maryland Greenebaum Cancer Center UMGCC has demonstrated that the combination of KML001 and cisplatin is synergistic in lung cancer cell lines Cisplatin is the best established agent for the treatment of lung cancer and most treatment regimens have been established with cisplatin or its congener carboplatin This synergism is particularly interesting given that there is an anti-telomere effect for cisplatin
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 |
|---|---|---|---|
| GCC 0805 | OTHER | University of Maryland Greenebaum Cancer Center | None |