Trial Outcomes & Findings for Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva (NCT NCT00504023)

Last Updated: 2018-06-06

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

12 weeks post treatment

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Imiquimod This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imiquimod n=8 Participants This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
Age, Continuous	72 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks post treatment

Outcome measures

Outcome measures
Measure	Imiquimod n=8 Participants This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
Percentage of Participants With Clinical and Histologic Remission	75 % of participants

Adverse Events

Imiquimod

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Imiquimod n=8 participants at risk This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
Musculoskeletal and connective tissue disorders Pain - Joint	12.5% 1/8 • 2 years
Musculoskeletal and connective tissue disorders Pain - Muscle	12.5% 1/8 • 2 years

Other adverse events

Other adverse events
Measure	Imiquimod n=8 participants at risk This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
Eye disorders Dry Eye	12.5% 1/8 • 2 years
Gastrointestinal disorders Dry mouth	12.5% 1/8 • 2 years
General disorders Fatigue	12.5% 1/8 • 2 years
Nervous system disorders Pain - Head/Headache	12.5% 1/8 • 2 years
Musculoskeletal and connective tissue disorders Pain - Joint	12.5% 1/8 • 2 years
Musculoskeletal and connective tissue disorders Pain - Muscle	12.5% 1/8 • 2 years
Skin and subcutaneous tissue disorders Pruritus/Itching	12.5% 1/8 • 2 years
Skin and subcutaneous tissue disorders Rash/desquamation	12.5% 1/8 • 2 years

Additional Information

Dr. Dennis Chi, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-5016

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place