Status:
TERMINATED
Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)
Lead Sponsor:
Kavita Sarin
Collaborating Sponsors:
Medivir
Conditions:
Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to determine if 8 weeks of topical remetinostat applied three times daily will suppress Squamous Cell Carcinoma.
Detailed Description
The primary purpose of this study is: * to determine if 8 weeks of topical remetinostat gel applied 3 times daily (TID) under occlusion will suppress SCC growth * to determine the overall response ra...
Eligibility Criteria
Inclusion
- Must have at least one biopsy-proven cutaneous SCC or SCC in situ (SCC-IS) lesion greater than or equal to 5 mm. Non-invasive SCC lesion(s), including Bowen's disease (SCC-IS), are eligible, but must be amenable to surgical resection.
- 18 years of age or older.
- Must be willing to apply the topical remetinostat 3 times daily for 8 weeks and cover with an occlusive bandage.
- Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months)
- Sexually active women of child bearing potential (WCBP) and male patients with a female partner of child-bearing potential must agree to use acceptable methods of contraception to avoid pregnancy (for example, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) before the first dose of study therapy and for 3 months after the last dose of study therapy
- Has signed and dated the current, approved informed consent document.
Exclusion
- Any large (\> 20 mm) SCC lesion. Patients with large SCC lesion(s) will be referred for evaluation for surgical resection.
- Inoperable locally-advanced and/or non-cutaneous metastatic SCC.
- SCC lesion(s) in cosmetically-sensitive areas (e.g. tip of nose, eyelid) are not eligible for enrollment. (If a patient has SCC lesion(s) in other areas, those tumor(s) may be considered for enrollment.)
- Taking any medication known to affect SCC growth
- Within the past 6 months, has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study. Specifically, these include the topical use at the site of the study tumors:
- Glucocorticoids
- Retinoids either systemically or topically at the tumor site (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene)
- Alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to the tumor site
- 5-fluorouracil or imiquimod
- Has received treatment with systemic chemotherapy within 60 days prior to starting study medication.
- Currently receiving systemic medications that could affect SCC tumors (e.g., oral retinoids) or might interact with remetinostat
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, recurrent seizure history or psychiatric illness/social situations that would limit compliance with study requirements.
- Moderate to significant immunosuppression (e.g., active cancer, significant autoimmune disease) and/or receiving immunosuppressive drugs that result in moderate to significant immunosuppression (e.g. low dose oral glucocorticoids do not necessarily exclude a patient)
- Known or previous hypersensitivity to HDACi
- History of congestive heart failure, cardiac arrhythmias, or other findings of ventricular dysfunction.
- Pregnancy or breast-feeding.
Key Trial Info
Start Date :
December 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03875859
Start Date
December 12 2019
End Date
January 30 2021
Last Update
May 20 2021
Active Locations (1)
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1
Stanford Medical Center
Stanford, California, United States, 94304