Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098891
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2004-12-08
Brief Title:
MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of an Oral Histone Deacetylase Inhibitor MS-275 NSC 706995 IND 61198 in Combination With 13-Cis-Retinoic Acid in Metastatic Progressive Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of combining MS-275 with isotretinoin in treating patients who have metastatic or advanced solid tumors or lymphomas MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth Isotretinoin may help cancer cells develop into normal cells MS-275 may increase the effectiveness of isotretinoin by making cancer cells more sensitive to the drug MS-275 and isotretinoin may also stop the growth of solid tumors or lymphomas by stopping blood flow to the cancer Combining MS-275 with isotretinoin may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the dose-limiting toxicity and maximum tolerated dose of MS-275 when administered with isotretinoin in patients with metastatic progressive refractory or unresectable solid tumors or lymphomas
SECONDARY OBJECTIVES
I Determine preliminarily tumor response in patients treated with this regimen
II Determine the pharmacokinetic profile of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of MS-275
Patients receive oral MS-275 once on days 1 8 and 15 and oral isotretinoin twice daily on days 1-21 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of MS-275 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Up to 12 patients are treated at the MTD
Patients are followed monthly
I Determine the dose-limiting toxicity and maximum tolerated dose of MS-275 when administered with isotretinoin in patients with metastatic progressive refractory or unresectable solid tumors or lymphomas
SECONDARY OBJECTIVES
I Determine preliminarily tumor response in patients treated with this regimen
II Determine the pharmacokinetic profile of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of MS-275
Patients receive oral MS-275 once on days 1 8 and 15 and oral isotretinoin twice daily on days 1-21 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of MS-275 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Up to 12 patients are treated at the MTD
Patients are followed monthly
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 |
|---|---|---|---|
| CDR0000396776 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA070095 |
| JHOC-J0438 | None | None | None |
| U01CA070095 | NIH | None | None |