Resiquimod Topical Gel in Treating Patients With Stage I-IIA Cutaneous T Cell Lymphoma

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase II, Phase ITreatment18 and overUPCC 03411
NCI-2012-00748, NCT01497795, NCT01676831

Trial Description

Summary

The purpose of this study is to determine the safety and tolerability of two concentrations (0.06% and 0.2%) of an investigational drug called resiquimod (resiquimod topical gel) when applied to lesions of early stage cutaneous T cell lymphoma (CTCL). Resiquimod is a gel that is applied to the skin which affects how the immune (protective) system responds to CTCL. Resiquimod gel causes cells to produce proteins which have been found to have an affect on CTCL. An additional purpose is to determine how well the resiquimod gel reduces the size of the CTCL skin lesions.

Further Study Information

PRIMARY OBJECTIVES:

I. To explore the safety and preliminary efficacy of two concentrations of resiquimod gel applied to lesions of early stage (IA, IB, IIA) CTCL.

OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 treatment groups.

GROUP 1: Patients apply lower-concentration resiquimod topical gel 3 times per week for 8 weeks.

GROUP 2: Patients apply higher-concentration resiquimod topical gel once weekly for 8 weeks.

In both groups, the dosing frequency (1, 2, 3, 5, or 7 times per week) may be adjusted after each two week interval based on the physician assessment of tolerability. Treatment repeats every 12 weeks for up to two courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Eligibility Criteria

Inclusion Criteria:

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 epidermotropic or folliculocentric T-cells)

Willing to abstain from therapeutic sunbathing, tanning beds, etc. for the duration of 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 and able to discontinue prohibited concomitant medications and/or treatments for CTCL during the study

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 provide written informed consent

Generally healthy other than for CTCL, or with other stable diseases/conditions that are adequately controlled

Have measurable skin disease with 1 to 4 eligible baseline target lesions with a total area >= 25 cm^2 but =< 100 cm^2; eligible lesions must be below the neck and may not involve the genitalia, intertriginous areas, internally, or to frankly ulcerated or infected skin

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, psoralen and ultraviolet A (PUVA), ultraviolet B (UVB), total body electron beam radiation, biological response or oral methotrexate

Have stage IA, IB or IIA: T1 or T2 (patches or plaques) with measurable lesions

Exclusion Criteria:

Have a grade 2 or greater laboratory abnormalities (Common Terminology Criteria for Adverse Events version 4 [CTCAE v4]) at baseline for any of the following:

Hemoglobin

White blood cell count

Platelet count

Alanine transferase

Aspartate transferase

Creatinine

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)

Have an active chemical or alcohol dependency as assessed by the investigator

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

Are pregnant or nursing, or intending to become pregnant within the duration of the study

Have a known history of or a positive serologic test for infection with human immunodeficiency virus or human T lymphotrophic virus

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

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)

Are unable to discontinue current treatment for CTCL due to risk of progression

Require immediate treatment for progressive CTCL

Stage IIB or greater CTCL

Have a known allergy to resiquimod or any of the excipients in the study drug

Within 8 weeks of treatment initiation (day 0), have received treatment with:

Imiquimod

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

PUVA

Any topical chemotherapy

Photopheresis

Systemic retinoids, corticosteroids, immune response modifiers (other than imiquimod), interferon inducers, chemotherapeutic agents, biologic agents including interferon

Topical corticosteroids or retinoids

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

University of Pennsylvania/Abramson Cancer Center

  • National Cancer Institute
Alain H. Rook, Principal Investigator

Trial Sites

U.S.A.

Pennsylvania
Philadelphia

University of Pennsylvania/Abramson Cancer Center

Alain H. Rook
Ph: 215-662-2812
Email: arook@mail.med.upenn.edu

Alain H. Rook
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01676831

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.