Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00007345
Status:
COMPLETED
Last Update Posted:
2017-05-16
First Post:
2000-12-16
Brief Title:
Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Trial of Depsipeptide in Patients With Cutaneous T-Cell Lymphoma and Relapsed Peripheral T-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-04
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:
Background
NSC630176 is a depsipeptide fermentation product from Chromobacterium violaceum with potent cytotoxic activity against human tumor cell lines and in vivo efficacy against both human tumor xenografts and murine tumors 1-3
NSC 630176 herein referred to as depsipeptide shows a lack of cross resistance with several commonly used cytotoxic agents such as vincristine 5-fluorouracil mitomycin C and cyclophosphamide 2 However it has been defined as a P-glycoprotein Pgp substrate by COMPARE analysis of the National Cancer Institute NCI drug screen cytotoxicity profile 4
Depsipeptide is a member of a novel class of antineoplastic agents the histone deacetylase inhibitors
In the phase I trial conducted at the National Cancer Institute NCI responses were observed at the maximum tolerated dose MTD in patients with cutaneous and peripheral T-cell lymphoma
Objectives
In patients with cutaneous T-cell lymphoma the primary end points to be examined are overall response rate complete response rate and duration of response
In patients with relapsed peripheral T-cell lymphoma the endpoints to be examined are overall response rate and complete response rate
To evaluate the tolerability of depsipeptide with extended cycles of therapy
Eligibility
Patients with cutaneous T-cell lymphoma mycosis fungoides or Sezary syndrome or other peripheral T-cell lymphomas are eligible
Design
Depsipeptide will be administered at 14 mgm2 over 4 hours on days 1 8 and 15
This trial will accrue in six cohorts Arm 1 patients with cutaneous T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens Arm 2 patients with peripheral T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens Arm 3 patients with cutaneous and peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens Arm 4 patients with other mature T-cell lymphomas Arm 5 a replicate arm of arm 1 Arm 6 patients with peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens Arm 7 patients with cutaneous T cell lymphoma who have received vorinostat
Dose may be adjusted based on toxicities
NSC630176 is a depsipeptide fermentation product from Chromobacterium violaceum with potent cytotoxic activity against human tumor cell lines and in vivo efficacy against both human tumor xenografts and murine tumors 1-3
NSC 630176 herein referred to as depsipeptide shows a lack of cross resistance with several commonly used cytotoxic agents such as vincristine 5-fluorouracil mitomycin C and cyclophosphamide 2 However it has been defined as a P-glycoprotein Pgp substrate by COMPARE analysis of the National Cancer Institute NCI drug screen cytotoxicity profile 4
Depsipeptide is a member of a novel class of antineoplastic agents the histone deacetylase inhibitors
In the phase I trial conducted at the National Cancer Institute NCI responses were observed at the maximum tolerated dose MTD in patients with cutaneous and peripheral T-cell lymphoma
Objectives
In patients with cutaneous T-cell lymphoma the primary end points to be examined are overall response rate complete response rate and duration of response
In patients with relapsed peripheral T-cell lymphoma the endpoints to be examined are overall response rate and complete response rate
To evaluate the tolerability of depsipeptide with extended cycles of therapy
Eligibility
Patients with cutaneous T-cell lymphoma mycosis fungoides or Sezary syndrome or other peripheral T-cell lymphomas are eligible
Design
Depsipeptide will be administered at 14 mgm2 over 4 hours on days 1 8 and 15
This trial will accrue in six cohorts Arm 1 patients with cutaneous T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens Arm 2 patients with peripheral T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens Arm 3 patients with cutaneous and peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens Arm 4 patients with other mature T-cell lymphomas Arm 5 a replicate arm of arm 1 Arm 6 patients with peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens Arm 7 patients with cutaneous T cell lymphoma who have received vorinostat
Dose may be adjusted based on toxicities
Detailed Description:
Background
NSC630176 is a depsipeptide fermentation product from Chromobacterium violaceum with potent cytotoxic activity against human tumor cell lines and in vivo efficacy against both human tumor xenografts and murine tumors 1-3
NSC 630176 herein referred to as depsipeptide shows a lack of cross resistance with several commonly used cytotoxic agents such as vincristine 5-fluorouracil mitomycin C and cyclophosphamide 2 However it has been defined as a P-glycoprotein Pgp substrate by COMPARE analysis of the National Cancer Institute NCI drug screen cytotoxicity profile 4
Depsipeptide is a member of a novel class of antineoplastic agents the histone deacetylase inhibitors
In the phase I trial conducted at the NCI responses were observed at the maximum tolerated dose MTD in patients with cutaneous and peripheral T-cell lymphoma
Objectives
In patients with cutaneous T-cell lymphoma the primary end points to be examined are overall response rate complete response rate and duration of response
In patients with relapsed peripheral T-cell lymphoma the endpoints to be examined are overall response rate and complete response rate
To evaluate the tolerability of depsipeptide with extended cycles of therapy
Eligibility
Patients with cutaneous T-cell lymphoma mycosis fungoides or Sezary syndrome or other peripheral T-cell lymphomas are eligible
Design
Depsipeptide will be administered at 14 mgm2 over 4 hours on days 1 8 and 15
This trial will accrue in six cohorts Arm 1 patients with cutaneous T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens Arm 2 patients with peripheral T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens Arm 3 patients with cutaneous and peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens Arm 4 patients with other mature T-cell lymphomas Arm 5 a replicate arm of arm 1 Arm 6 patients with peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens Arm 7 patients with cutaneous T cell lymphoma who have received vorinostat
Dose may be adjusted based on toxicities
NSC630176 is a depsipeptide fermentation product from Chromobacterium violaceum with potent cytotoxic activity against human tumor cell lines and in vivo efficacy against both human tumor xenografts and murine tumors 1-3
NSC 630176 herein referred to as depsipeptide shows a lack of cross resistance with several commonly used cytotoxic agents such as vincristine 5-fluorouracil mitomycin C and cyclophosphamide 2 However it has been defined as a P-glycoprotein Pgp substrate by COMPARE analysis of the National Cancer Institute NCI drug screen cytotoxicity profile 4
Depsipeptide is a member of a novel class of antineoplastic agents the histone deacetylase inhibitors
In the phase I trial conducted at the NCI responses were observed at the maximum tolerated dose MTD in patients with cutaneous and peripheral T-cell lymphoma
Objectives
In patients with cutaneous T-cell lymphoma the primary end points to be examined are overall response rate complete response rate and duration of response
In patients with relapsed peripheral T-cell lymphoma the endpoints to be examined are overall response rate and complete response rate
To evaluate the tolerability of depsipeptide with extended cycles of therapy
Eligibility
Patients with cutaneous T-cell lymphoma mycosis fungoides or Sezary syndrome or other peripheral T-cell lymphomas are eligible
Design
Depsipeptide will be administered at 14 mgm2 over 4 hours on days 1 8 and 15
This trial will accrue in six cohorts Arm 1 patients with cutaneous T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens Arm 2 patients with peripheral T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens Arm 3 patients with cutaneous and peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens Arm 4 patients with other mature T-cell lymphomas Arm 5 a replicate arm of arm 1 Arm 6 patients with peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens Arm 7 patients with cutaneous T cell lymphoma who have received vorinostat
Dose may be adjusted based on toxicities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 01-C-0049 | None | None | None |