Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma (CTCL)
This study is currently recruiting participants.
Verified August 2012 by University of Pennsylvania
Information provided by (Responsible Party):
Alain Rook, University of Pennsylvania
First received: July 15, 2012
Last updated: August 30, 2012
Last verified: August 2012
The objective of this study is to explore the safety and the preliminary efficacy of two concentrations (0.06% and 0.2%)gel that is applied to lesions of early stage (IA, IB,IIA) Cutaneous T Cell Lymphoma patients.
Cutaneous T Cell Lymphoma
Drug: Topical resiquimod 0.06%
Drug: topical resiquimod 0.2%
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I/IIa, Dose-Ranging Safety and Efficacy Study of Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2014 (Final data collection date for primary outcome measure)
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.
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.
Experimental: topical resiquimod 0.2%
Topical resiquimod 0.2% will be applied once weekly for 8 weeks. Patient will be evaluated every 2 weeks for tolerability.
Drug: topical resiquimod 0.2%
topical resiquimod 0.2% applied once weekly for 8 weeks.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 with histological findings consistent with CTCL (atypical epidermotrophic or folliculocentric T-cells). Unconfirmed diagnosis of CTCL must have a biopsy to confirm at screening
- Have Stage IA, IB or IIA: T1 or T2 (patches or plaques) with measurable lesions.
- Previous treatment with at least one standard therapy used to treat Stage IA, IB or IIA CTCL including but not limited to oral corticosteroids, high-potency topical corticosteroids, topical mechlorethamine, topical bexarotene, PUVA, UVB, total body electron beam radiation, biological response or oral methotrexate.
- Have measurable skin disease with at least 1 to 4 eligible baseline target lesions with a total area >25 cm2 but <100 cm2. Eligible lesions must be below the neck and may not involve the genitalia, intertriginous areas, internally, or to frankly ulcerated or infected skin.
- Generally healthy other than for CTCL, or with other stable diseases/conditions that are adequately controlled.
- Willing and able to provide written informed consent.
- Willing and able to adhere to the protocol requirements, including but not limited to study drug dosing, study drug visits, medication and treatment restrictions, and laboratory tests.
- Willing and able to discontinue concomitant medications or treatments for CTCL during the study.
- If a female of child bearing potential, willing to use adequate contraception (defined as double-method contraception, e.g. oral contraceptive usage by subject and condom by partner). Non-child bearing potential is defined as being at least 2 years post-menopausal or being surgically sterile.
- Willing to abstain from therapeutic sunbathing, tanning beds, etc. for the duration of the study.
- 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.
Within 8 weeks of treatment initiation (Day 0), have received treatment with:
- Total body electron beam radiation
- Investigational drugs or treatments
Within 4 weeks of treatment initiation (Day 0), have received treatment with:
- Local radiation therapy
- UVB therapy
- Any topical chemotherapy
- Systemic retinoids, corticosteroids, immune response modifiers (other than imiquimod), interferon inducers, chemotherapeutic agents, biologic agents including interferon
- Topical corticosteroids or retinoids
Within 2 weeks of treatment initiation (Day 0), have received at or adjacent to the target treatment lesions.
- Any surgical procedures other than biopsies related to CTCL diagnosis or follow-up
- Any topical treatment other than bland moisturizers (creams, lotions, emollients, etc).
- Have other concurrent cutaneous conditions in the treatment area or immediately adjacent to the treatment area that would be exacerbated by resiquimod or interfere with assessments.
Have a grade 2 or greater laboratory abnormalities (CTCAE v4) at baseline for any of the following:
- White blood cell count
- Platelet count
- Alanine transferase
- Aspartate transferase
- Have a known history of or a positive serologic test for infection with human immunodeficiency virus or human T lymphotrophic virus.
- Are pregnant or nursing, or intending to become pregnant within the duration of the study.
- Have any clinically significant medical conditions that are unstable, progressive, or inadequately controlled in the opinion of the investigator, that would pose a potential risk for the subject, result in poor compliance with the study requirements, or require treatment with an excluded medication or treatment during the study.
- Have an active chemical or alcohol dependency as assessed by the investigator.
- Have systemic collagen vascular disorder, systemic autoimmune disease, an organ transplant or diagnosis of cancer within 5 years other than CTCL (not including basal cell carcinoma, non-invasive squamous cell cancer of the skin, malignant melanoma in situ, or cervical carcinoma in situ).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676831
|University of Pennsylvania
|Philadelphia, Pennsylvania, United States, 19104 |
|Contact: Alain Rook, MD 215-662-7610 email@example.com |
University of Pennsylvania
||Alain H Rook, M.D.
||University of Pennsylvania
No publications provided
||Alain Rook, Professor of Dermatology, University of Pennsylvania
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 15, 2012
||August 30, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 22, 2013
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Immune System Diseases