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A Phase I/IIa, Dose-Ranging Safety and Efficacy Study of Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cutaneous T Cell Lymphoma

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Trial Information

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 to determine the safety and tolerability of an investigational drug called
resiquimod gel applied in 2 concentrations(0.06% & 0.2%) when applied to lesions of early
stage (IA, IB, IIA) CTCL.Eligible subjects will be enrolled in to 2 treatment groups of up
to 8 subjects each.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. After the first 8 subjects have been evaluated in treatment #
1, Treatment group # 2 will begin and apply resiquimod gel (0.2%) as above. (With respect to
the escalation of the concentration from 0.06% to 0.2%, escalation will only be permitted if
at least six of eight patients on 0.06% tolerate treatment at 2x/wk or more.)

Key Eligibility criteria include:

1. Males or female 18 years of age at the time of study enrollment

2. Have a clinical diagnosis of cutaneous T cell lymphoma (CTCL)

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

Addendum:

The study is divided into 3 parts: Screening Period; Course of Treatment #1; and Course of
Treatment #2.

Resiquimod will be applied for 8 weeks (COT1) followed by a 4 week no-treatment period. If
the subject has not required permanent discontinuation from treatment, the subject will
repeat a second course of treatment of 8 weeks (COT2) followed by a 4 week no-treatment
period.

Resiquimod will be applied in dosing frequencies that are periodically adjusted according to
tolerability. Subjects (treatment group # 1 )will begin dosing at 3 times per week (3/wk),
and will be evaluated at the clinic every two weeks. Treatment Group # 2 will begin dosing
at 1 time a week (1/wk) after group #1 has been fully evaluated.The dosing frequency (1, 2,
3, 5, or 7/wk) ( for both groups) may be adjusted in a stepwise manner after each two week
interval based on the physician assessment of tolerability (maintained, increased, decreased
with or without a dosing interruption [rest period]. This will be based on the investigator
assessment of LSRs and ASRs of the treatment area(s) LSRs in the treatment and/or immediate
surrounding area will be clinically identified for the following:

- erythema

- edema

- weeping/exudate

- erosion/ulceration

- flaking/scaling/dryness

- scabbing/crusting

Other application site adverse events (AE) include:

vesicles, burning, itching, bleeding, soreness, and induration

Local Skin Reaction Scale for Investigators and Table 6.4.4.A Adjustment Guideline for LSRs
and AEs listed on Page 38 and 40 of protocol will be followed to determine dose adjustments
or early termination.

Study drug will be permanently discontinued for a subject for any AE requiring a full rest
that does not adequately resolve to resume dosing per protocol. If the applicable rest
occurred in COT1, the AE must have adequately resolved by the 4 week post COT1 visit in
order to initiate dosing in COT2. If the applicable rest occurred in COT2, the AE must have
adequately resolved prior to the End of COT2 visit

Subjects may also be discontinued from treatment if the investigator has determined that
LSRs or AEs are of sufficient intensity or duration to warrant permanent treatment
discontinuation, or if a subject needs to have treatment for another condition requiring
treatment with an excluded treatment that may be of a safety concern

Blood tests will be done to monitor patient safety. Females of childbearing potential will
undergo a urine pregnancy test @ screening,baseline, visit 4, visit 6, visit 7, visit 9,
visit 11 and visit 12.

Any subject who becomes pregnant during treatment must be discontinued from further
treatment.

All pregnancies will be immediately reported to the PI/sponsor and medical monitor and
followed through to resolution.A pregnancy notification form and pregnancy outcome form will
be completed.(both attached under supporting documents)

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Adverse Events

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

UPCC 03411

NCT ID:

NCT01497795

Start Date:

December 2011

Completion Date:

June 2013

Related Keywords:

  • Cutaneous T Cell Lymphoma
  • CTCL
  • documentation of a skin biopsy within the prior 3 years
  • histological findings consistent with CTCL
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283