Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Vemurafenib

Acitretin

Protein Kinase Inhibitors

Enzyme Inhibitors

Keratolytic Agents

Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.

A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Lee Cranmer, MD, PhD

We propose to conduct a phase 2 study to assess whether the addition of acitretin to vemurafenib therapy is able to decrease the rate of cutaneous squamous cell carcinoma (cSCC) development, a known side effect of vemurafenib therapy, in patients with advanced melanoma. Further, we seek a preliminary assessment as to whether the addition of acitretin to vemurafenib enhances the clinical efficacy of this anti-melanoma agent.

A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma

The study period during which all AEs must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier. All adverse events will be classified using either the MedDRA term or NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

University of Arizona

Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.

Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Acitretin and Vemurafenib

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Lee Cranmer

Per the PI: There is no measurable or interpretable data for this study. Only two patients were enrolled before the study closed to accrual due to recent FDA approvals of drugs for melanoma.Patients were removed from protocol prior to reaching data points or the completing the study.

Rate of Development of cSCC at 6 Months (Biopsy Confirmed).

Per the PI: Although there is no measurable or interpretable data for this study. One patient had higher than normal liver lab results and was removed from study treatment due to grade and severity. Patient safety was evaluated.

Number of Participants With Adverse Events

Overall Study

Spots Global Cancer Trial Database for A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial