Ignite Creation Date:
2024-05-05 @ 11:54 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01445340
Status:
TERMINATED
Last Update Posted:
2019-12-17
First Post:
2011-09-30
Brief Title:
Topical Romidepsin to Treat Early-Stage Cutaneous T-Cell Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study of Topical Romidepsin Depsipeptide in Early Stage Cutaneous T-Cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2012-06-29
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
Cutaneous T-cell lymphoma CTCL is a rare slow-growing form of skin cancer The cancer cells are found in red scaly patches that may sometimes itch
Early-stage CTCL is usually treated with topical therapies which may lose effectiveness over time and have adverse effects such as risk of secondary skin cancers and difficulty of use
Romidepsin is an experimental drug that given through a vein has improved CTCL in some patients with later stages of the disease
A topical ointment form of romidepsin may be helpful in treating early-stage CTCL
Objectives
To determine the highest tolerated dose of topical romidepsin that can be given to patients with early-stage CTCL
To evaluate the effectiveness of topical romidepsin in patients with early-stage CTCL
To determine how the body handles topical romidepsin
Eligibility
-Patients 18 of age and older with early-stage CTCL
Design
Study Part 1 Successive groups of 3 patients are treated with increasingly higher concentrations of topical romidepsin until the highest tolerated dose is found
Study Part II The highest tolerated dose as determined in Part I is applied to larger areas of skin in another group of patients
All study participants apply the study medicine to their skin three times a day for 4 weeks
During treatment participants are monitored at weeks 2 and 4 with a history and physical examination blood tests electrocardiogram skin biopsies and photographs of the skin
After stopping treatment participants return to the clinic at weeks 6 and 8 for blood tests and to see how the study medication is affecting the body
Cutaneous T-cell lymphoma CTCL is a rare slow-growing form of skin cancer The cancer cells are found in red scaly patches that may sometimes itch
Early-stage CTCL is usually treated with topical therapies which may lose effectiveness over time and have adverse effects such as risk of secondary skin cancers and difficulty of use
Romidepsin is an experimental drug that given through a vein has improved CTCL in some patients with later stages of the disease
A topical ointment form of romidepsin may be helpful in treating early-stage CTCL
Objectives
To determine the highest tolerated dose of topical romidepsin that can be given to patients with early-stage CTCL
To evaluate the effectiveness of topical romidepsin in patients with early-stage CTCL
To determine how the body handles topical romidepsin
Eligibility
-Patients 18 of age and older with early-stage CTCL
Design
Study Part 1 Successive groups of 3 patients are treated with increasingly higher concentrations of topical romidepsin until the highest tolerated dose is found
Study Part II The highest tolerated dose as determined in Part I is applied to larger areas of skin in another group of patients
All study participants apply the study medicine to their skin three times a day for 4 weeks
During treatment participants are monitored at weeks 2 and 4 with a history and physical examination blood tests electrocardiogram skin biopsies and photographs of the skin
After stopping treatment participants return to the clinic at weeks 6 and 8 for blood tests and to see how the study medication is affecting the body
Detailed Description:
Background
Romidepsin is a histone deacetylase inhibitor which has demonstrated efficacy and tolerability as an infusion in later stages of cutaneous T-cell lymphoma CTCL
Early stages of CTCL are typically treated with skin-directed therapies which may lose efficacy over time and have adverse effects ie risk of secondary skin cancers difficulty of use
A topical form of romidepsin may be helpful in the treatment of early-stage CTCL
Objectives
Primary - To define the maximal tolerated dose MTD of topical romidepsin for early-stage CTCL when administered three times weekly then escalated first in concentration followed by increased frequency and lastly over increasing body surface areas
Secondary - To assess histone acetylation in topical romidepsin-treated skin
Secondary - To assess in a pilot fashion clinical efficacy of topical romidepsin in early stage cutaneous T-cell lymphoma
Secondary - To perform pharmacokinetic monitoring of blood levels of romidepsin in topically treated patients
Eligibility
-Patients age greater than or equal to 18 with confirmed early-stage stage IA IB or IIA cutaneous T-cell lymphoma
Design
A Cohorts of Three design to define the MTD of topical romidepsin in Aquaphor ointment initially applied overnight three times weekly for 4 weeks then escalated first in concentration followed by increased frequency and lastly over increasing body surface areas
Skin toxicities systemic toxicities and disease response will be assessed throughout the study
The primary focus of the first part of the protocol will be to evaluate local skin toxicity beginning with dose level 1 of 005 percent topical romidepsin on 25 cm2 target area 0005 mg cm2 If tolerated progress to higher dose levels of 025 percent 0025 mg cm2 dose level 2 and then 05 percent 005 mg cm2 dose level 3 topical romidepsin on 25 cm2 target area Systemic toxicity will also be monitored
To date we have completed the first 4 dose levels and have not yet established cutaneous MTD To achieve this we will proceed to the second part of the protocol which will increase the concentration to 1 then increase the frequency to daily application then progress to 2 concentration then 4 concentration and then applying to progressively larger body surface areas Our aim is to more fully address systemic toxicity by increasing drug concentration application frequency and body surface area BSA treated We will utilize topical romidepsin at the MTD on increasing BSA lesional nonlesional skin multiple lesions up to 3 BSA dose level 4 multiple lesions up to 25 BSA dose level 7A 50 BSA dose level 7B and 75 or BSA dose level 7C
Romidepsin is a histone deacetylase inhibitor which has demonstrated efficacy and tolerability as an infusion in later stages of cutaneous T-cell lymphoma CTCL
Early stages of CTCL are typically treated with skin-directed therapies which may lose efficacy over time and have adverse effects ie risk of secondary skin cancers difficulty of use
A topical form of romidepsin may be helpful in the treatment of early-stage CTCL
Objectives
Primary - To define the maximal tolerated dose MTD of topical romidepsin for early-stage CTCL when administered three times weekly then escalated first in concentration followed by increased frequency and lastly over increasing body surface areas
Secondary - To assess histone acetylation in topical romidepsin-treated skin
Secondary - To assess in a pilot fashion clinical efficacy of topical romidepsin in early stage cutaneous T-cell lymphoma
Secondary - To perform pharmacokinetic monitoring of blood levels of romidepsin in topically treated patients
Eligibility
-Patients age greater than or equal to 18 with confirmed early-stage stage IA IB or IIA cutaneous T-cell lymphoma
Design
A Cohorts of Three design to define the MTD of topical romidepsin in Aquaphor ointment initially applied overnight three times weekly for 4 weeks then escalated first in concentration followed by increased frequency and lastly over increasing body surface areas
Skin toxicities systemic toxicities and disease response will be assessed throughout the study
The primary focus of the first part of the protocol will be to evaluate local skin toxicity beginning with dose level 1 of 005 percent topical romidepsin on 25 cm2 target area 0005 mg cm2 If tolerated progress to higher dose levels of 025 percent 0025 mg cm2 dose level 2 and then 05 percent 005 mg cm2 dose level 3 topical romidepsin on 25 cm2 target area Systemic toxicity will also be monitored
To date we have completed the first 4 dose levels and have not yet established cutaneous MTD To achieve this we will proceed to the second part of the protocol which will increase the concentration to 1 then increase the frequency to daily application then progress to 2 concentration then 4 concentration and then applying to progressively larger body surface areas Our aim is to more fully address systemic toxicity by increasing drug concentration application frequency and body surface area BSA treated We will utilize topical romidepsin at the MTD on increasing BSA lesional nonlesional skin multiple lesions up to 3 BSA dose level 4 multiple lesions up to 25 BSA dose level 7A 50 BSA dose level 7B and 75 or BSA dose level 7C
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 |
|---|---|---|---|
| 07-C-0133 | None | None | None |