Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma (CTCL)
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|ClinicalTrials.gov Identifier: NCT01676831|
Recruitment Status : Active, not recruiting
First Posted : August 31, 2012
Last Update Posted : September 20, 2016
The objective of this study is to explore the safety and the preliminary efficacy of two concentrations (0.06% and 0.03%)gel that is applied to lesions of early stage (IA, IB,IIA) Cutaneous T Cell Lymphoma patients.
This study is supported by grant 1R01FD004092-01A1 from the Office of Orphan Products Development, FDA.
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T Cell Lymphoma||Drug: Topical resiquimod 0.06% Drug: topical resiquimod 0.03%||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIa, Dose-Ranging Safety and Efficacy Study of Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||January 2015|
Experimental: topical resiquimod 0.06%
Topical resiquimod 0.06% will be applied in dosing frequencies that are periodically adjusted to tolerability. Dosing frequency will be 3 times a week. The dosing frequency may be adjusted (1,2,3,5,or 7times per week) based on the physician assessment of tolerability. Treatment will occur for 8 weeks followed by 4 weeks rest followed by another 8 weeks of treatment with 4 weeks rest. At 24 weeks a final evaluation will be performed. Those with a partial response at week 24 will have the option to continue therapy for up to another 12 weeks.
Drug: Topical resiquimod 0.06%
topical resiquimod 0.06% dosing frequency begins at 3 times per week and evaluated every two weeks. Will be applied for a total of 8 weeks followed by 4 weeks rest and then followed by another 8 weeks of application with another 4 weeks rest.
Experimental: topical resiquimod 0.03%
Topical resiquimod 0.03% will be applied in dosing frequencies that are periodically adjusted to tolerability. Dosing frequency will begin 5 times a week. The dosing frequency may be adjusted (1,2,3,5,or 7times per week) based on the physician assessment of tolerability. Treatment will occur for 8 weeks followed by 4 weeks rest followed by another 8 weeks of treatment with 4 weeks rest. At 24 weeks a final evaluation will be performed. Those with a partial response at week 24 will have the option to continue therapy for up to another 12 weeks.
Drug: topical resiquimod 0.03%
topical resiquimod 0.03% applied initially 5 times weekly for 8 weeks with adjustments up or down based upon tolerability followed by 4 weeks rest followed by another 8 weeks of treatment followed by another 4 week rest period.
- Drug tolerability data [ Time Frame: after 4 subjects have completed 4 weeks of study drug ]After four subjects have completed at least four weeks of study drug dosing a safety review meeting will be conducted by a committee. The committee will determine based on the review of the tolerability data the starting concentration/frequency of the next group. No subjects will be enrolled in the next concentration (0.03%)group until all eight have been evaluated in the 0.06% group.
- Secondary end points: Efficacy [ Time Frame: Up to 24 weeks or At the conclusion of patient therapy ]
The secondary endpoint is:
• The Response Rate (Complete or Partial Response) based on Composite Assessment of Index Lesions Disease Severity (CAILDS) score at EOS for the baseline target lesions. Complete Response is defined as a score of '0' on the CAILDS scale. Partial response is defined as a reduction of at least 50% in the CAILDS.The total surface area of involvement will also be assessed (SWAT score). A partial response will represent improvement in 50% or greater of the skin surface area with regression of lesions. A complete response will represent complete clear clearing of skin lesions and in the case of stage IIA patients, resolution of lymphadenopathy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676831
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Alain H Rook, M.D.||University of Pennsylvania|