A Phase I/IIa, Dose-Ranging Safety and Efficacy Study of Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma
This study is currently recruiting participants.
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01497795
First received: December 13, 2011
Last updated: February 25, 2013
Last verified: February 2013
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Purpose
The objective of this study is to explore the safety and preliminary efficacy of two concentrations of resiquimod gel applied to lesions of early stage (IA, IB, IIA) cutaneous T cell lymphoma (CTCL). Eligible subjects will be enrolled in up to 2 treatment groups of up to 8 subjects each. Treatment group #1 will apply 0.06% gel 3 times a week. Treatment group #2 will apply 0.2% gel once weekly to start. Resiquimod will be applied in dosing frequencies that are periodically adjusted according to tolerability.
| Condition | Intervention | Phase |
|---|---|---|
|
Cutaneous T Cell Lymphoma |
Other: Resiquimod gel (0.06%) Drug: Resiquimod gel (0.2%) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:
Primary Outcome Measures:
- Number of Participants with Adverse Events [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 16 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Phase 1 |
Other: Resiquimod gel (0.06%)
Subjects in first treatment group will apply resiquimod gel (0.06%) to 1-4 CTCL skin lesions in an area no larger than 100 cm2 (1/4 the size of a standard piece of paper) for two 8 week periods.
|
| Experimental: Phase 2 |
Drug: Resiquimod gel (0.2%)
After the first 8 subjects have been evaluated in treatment # 1, Treatment group # 2 will begin and apply resiquimod gel (0.2%)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Males or female 18 years of age at the time of study enrollment
- Have a clinical diagnosis of cutaneous T cell lymphoma CTCL, including documentation of a skin biopsy within the prior 3 years with histological findings consistent with CTCL (atypical epidermotrophic or folliculocentric T-cells).
- Have Stage IA, IB or IIA: T1 or T2 (patches or plaques) with measurable lesions
Exclusion criteria
- If subjects are excluded because of age, economic status, gender, race or ethnicity, provide the justification for exclusion.
Have a known allergy to resiquimod or any of the excipients in the study drug.
- Stage IIB or greater CTCL.
- Require immediate treatment for progressive CTCL.
- Are unable to discontinue current treatment for CTCL due to risk of progression
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497795
Contacts
| Contact: Alain Rook, MD | 855-216-0098 | PennCancerTrials@emergingmed.com |
Locations
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Alain Rook, MD 855-216-0098 PennCancerTrials@emergingmed.com | |
| Principal Investigator: Alain Rook, MD | |
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
More Information
No publications provided
| Responsible Party: | Abramson Cancer Center of the University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01497795 History of Changes |
| Other Study ID Numbers: | UPCC 03411 |
| Study First Received: | December 13, 2011 |
| Last Updated: | February 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
|
CTCL documentation of a skin biopsy within the prior 3 years histological findings consistent with CTCL |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on May 21, 2013