Clinical Trial With Local Decitabine Treatment of HPV-Induced VIN Grade 2/3 (DelVIN) (NCT05717621) | Clinical Trial Compass
CompletedPhase 1
Clinical Trial With Local Decitabine Treatment of HPV-Induced VIN Grade 2/3 (DelVIN)
Germany29 participantsStarted 2023-03-28
Plain-language summary
This is a multicentre open labelled phase I trial evaluating the safety and preliminary efficacy of local decitabine treatment of human papillomavirus (HPV)-induced vulvar intraepithelial neoplasia (VIN) grade 2/3.
The main purpose and primary objective of the study is to determine the recommended phase 2 dose (RP2D) of VTD-101 ointment for the topical treatment of HPV-induced VIN grade 2/3. The RP2D is defined as the dose that is safe, tolerable and effective. Corresponding endpoints are the rate of patients experiencing at least one dose limiting toxicity (DLT) and the rate of patients with clinical complete or partial response (cCR/cPR) according to adapted RECIST criteria.
Secondary objectives are to further characterize the efficacy of topical treatment with VTD-101 ointment, to further evaluate the safety and tolerability of topical treatment with VTD-101 ointment, and to evaluate quality of life (QoL) in patients treated with VTD-101 ointment.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
ā. Having provided written informed consent
ā. Women ā„ 18 years of age at the time of signing the written informed consent
ā. Women with histologically confirmed vulvar intraepithelial neoplasia (VIN) grade 2 or 3 (also referred to as "high grade VIN" or "high-grade squamous intraepithelial lesions \[HSIL\]")
ā. Uni- or multifocal VIN grade 2 or 3
ā. Newly diagnosed or recurrent VIN grade 2 or 3
ā. Women who refuse standard therapy, have not responded (or no longer respond) to standard therapy, have not tolerated standard therapy or for whom standard therapy is contraindicated
ā. Evidence of HPV-induced etiology of the lesion(s) as indicated by the detection of p16INK4a overexpression as well as high-risk (HR) HPV DNA presence in the lesion(s)
ā. Women of childbearing potential (WOCBP) must agree to use one highly effective contraceptive method during the treatment period and for at least 6 months after the last IMP administration
Exclusion criteria
What they're measuring
1
Determination of the dose that is safe and tolerable (by the assessment of the rate of patients (%) experiencing at least one dose limiting toxicity (DLT)) as part of the determination of the recommended phase 2 dose (RP2D).
Timeframe: 28 days
2
Determination of the dose that is effective (by the assessment of the rate of patients (%) with clinical complete or partial response (cCR/cPR) according to adapted RECIST criteria) as part of the determination of the recommended phase 2 dose (RP2D).
ā. Evidence for or suspicion of vulvar tumor invasion
ā. History of vulvar cancer
ā. Previous surgical (except biopsy) or medical procedures of the high-grade VIN within the past 4 weeks prior to treatment start
ā. Neutropenia or thrombocytopenia
ā. Known allergy or hypersensitivity against decitabine or any of the excipients contained in the formulation
ā. Current or prior use of immunosuppressive medication within 14 days (3 months for azathioprine, methotrexate, and tofacitinib) before the first dose of VTD-101 ointment. The following are exceptions to this criterion:
ā. Medical conditions associated with severe immunosuppression (e.g., acquired immune deficiency syndrome \[AIDS\])
ā. Active infection within the anogenital tract (except for HPV)