Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01377 | Registry Identifier | NCI CTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical research study is to learn if CD5789 is safe and tolerable when given to patients with early stage CTCL.
CD5789 is designed to attach to tumor cells and change their genetic material. This may stop the growth of the tumor cells.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will apply CD5789 cream 1 time each day. You should do this after you wash the area.
During your first study visit, the study staff will select which lesions you will apply cream to. The study staff will tell you how much cream to apply.
On Day 1, the study staff will apply the study drug on half of the lesions. You will apply the study drug to the rest of the lesions while the study staff watches. In a diary, the study staff will write down the time you applied the study drug. You must write down this information in the diary when you apply the study drug at home. On your Week 1 visit, you will apply the study drug at the clinic while the study staff watches.
You will use gloves to apply the study drug in a thin film on the lesions. Be careful not to overlap healthy skin. You should massage the study drug gently into the skin. If someone helps you apply the study drug, they must also wear gloves.
Bring the diary with you to each visit. You should return all unused study drug and/or empty tubes at each study visit.
You must avoid exposing the treated areas to the sun (you should wear clothing to cover these areas). You should also not swim or take a bath while on study, but you can take a shower at least 2 hours after you apply the drug.
If your skin is dry, you will be given a moisturizer (such as Cetaphil Restoraderm Skin Restoring Moisturizer) to use.
Study Visits:
At all study visits, you will asked about any drugs you may be taking or any side effects you may have had.
On Day 1:
At Weeks 1, 2, 4, and 8:
At Weeks 4 and 8, if you can become pregnant, urine will be collected for a urine pregnancy test.
Length of Study:
You may continue using the study drug for up to 12 weeks, as long as the study doctor thinks it is in your best interest. You will no longer be able to use the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over when you have completed the end-of-study visit.
All samples collected during the study will be destroyed after the study has been completed and all patients are off study.
End-of-Study Visit:
On the last day you apply the study drug (Week 12), you will have an end-of-study visit:
This is an investigational study. CD5789 is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 10 patients will take part in this study. All will be enrolled at MD Anderson.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD5789 0.01% Cream | Experimental | CD5789 0.01% cream applied on the lesions once daily for twelve weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD5789 0.01% Cream | Drug | CD5789 0.01% cream applied on the lesions once daily for twelve weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance Score of CD5789 0.01% Cream | Data analysis based on local tolerability score evaluated at each visit with a worst tolerance score for the subject calculated at each visit. Worst tolerance score is worst score of local tolerability of all index lesions for each subject at each visit. Worst tolerance score (max local tolerance score) summarized in frequency tables to follow the evolution of this score across visits for each subject. Index lesion(s) evaluated at each visit for local tolerance (using a 5-point scale) from Week 1 visit to Week 12/ Early Termination visit for each index lesion. Tolerance 5-point scale from 0-No reaction to 4-Severe where the higher number the worse reaction. | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Madeleine Duvic, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629420 | trifarotene |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |