Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334789
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2006-06-07
Brief Title:
Belinostat and Isotretinoin in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Trial of PXD101 in Combination With 13-cis-Retinoic Acid in Advanced Solid Tumor Malignancies
Status:
COMPLETED
Status Verified Date:
2017-10
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:
None
Brief Summary:
This phase I trial is studying the side effects and best dose of belinostat when given together with isotretinoin in treating patients with metastatic or unresectable solid tumors Belinostat may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth Isotretinoin may cause solid tumor cells to look more like normal cells and to grow and spread more slowly Giving belinostat together with isotretinoin may be an effective treatment for metastatic or unresectable solid tumors
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety and feasibility of combining PXD101 belinostat with 13-cis-retinoic acid 13-cRA isotretinoin in patients with advanced solid tumor malignancies
II To define the maximum tolerated dose MTD of PXD101 when administered in combination with 13-cRA and to describe the toxicities at each dose studied
III To evaluate the pharmacokinetics of PXD101 and 13-cRA when given in combination
SECONDARY OBJECTIVES
I To demonstrate upregulation of retinoic acid receptor-beta RARĪ² and retinoic X-receptor RXR expression in tumor tissues after treatment with PXD101 and 13-cRA
II To measure apoptosis in tumor biopsies after treatment III To assess the change in gene expression after exposure to PXD101 and 13-cRA
IV To document any clinical activity of the combination of PXD101 and 13-cRA
OUTLINE This is a multicenter dose-escalation study of belinostat
Patients receive belinostat intravenously IV over 30 minutes on days 1-5 and isotretinoin orally PO once daily QD on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of PXD101 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 during the first course of therapy
Once the MTD is determined an expanded cohort of 10 patients are enrolled and treated at the MTD These patients also undergo blood collection periodically during treatment for pharmacokinetic studies
All patients undergo blood collection buccal scrapings and tumor biopsies periodically for biomarker pharmacodynamic gene expression and laboratory studies
After completion of study treatment patients are followed for 8 weeks
I To assess the safety and feasibility of combining PXD101 belinostat with 13-cis-retinoic acid 13-cRA isotretinoin in patients with advanced solid tumor malignancies
II To define the maximum tolerated dose MTD of PXD101 when administered in combination with 13-cRA and to describe the toxicities at each dose studied
III To evaluate the pharmacokinetics of PXD101 and 13-cRA when given in combination
SECONDARY OBJECTIVES
I To demonstrate upregulation of retinoic acid receptor-beta RARĪ² and retinoic X-receptor RXR expression in tumor tissues after treatment with PXD101 and 13-cRA
II To measure apoptosis in tumor biopsies after treatment III To assess the change in gene expression after exposure to PXD101 and 13-cRA
IV To document any clinical activity of the combination of PXD101 and 13-cRA
OUTLINE This is a multicenter dose-escalation study of belinostat
Patients receive belinostat intravenously IV over 30 minutes on days 1-5 and isotretinoin orally PO once daily QD on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of PXD101 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 during the first course of therapy
Once the MTD is determined an expanded cohort of 10 patients are enrolled and treated at the MTD These patients also undergo blood collection periodically during treatment for pharmacokinetic studies
All patients undergo blood collection buccal scrapings and tumor biopsies periodically for biomarker pharmacodynamic gene expression and laboratory studies
After completion of study treatment patients are followed for 8 weeks
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-2009-00142 | REGISTRY | None | None |
| PHI-53 | None | None | None |
| CDR0000479715 | None | None | None |
| PHI-53 | OTHER | None | None |
| 7251 | OTHER | None | None |
| P30CA033572 | NIH | None | None |
| U01CA062505 | NIH | None | None |
| U01CA099168 | NIH | CTEP | httpsreporternihgovquickSearchU01CA099168 |