Skin and Connective Tissue Diseases

All Conditions

Exanthema

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Erlotinib Hydrochloride

Acitretin

Keratolytic Agents

Larisa J Geskin, MD

This study will look at if a low-dose regimen of acitretin is helpful in treating a skin rash caused by the chemotherapy drug, erlotinib.

This is a pilot trial with an initial target sample of 32 evaluable subjects. The study will last up to 12 weeks per subject and up to 9 months for the entire study. Cancer patients beginning antineoplastic therapy with the EGFR inhibitor erlotinib will be enrolled in this trial. Patients beginning erlotinib therapy will simultaneously initiate a skin care regimen consisting of twice daily application of Eucerin,TM Aveeno,TM or CeraveTM moisturizing cream and daily application of SPF 15 or greater sunscreen.

Those patients who develop rash of CTCAE Grade 2 or higher will be referred to us by their primary oncologist. Upon onset of the cutaneous eruption, the oncologist will initiate therapy with doxycycline (100 mg twice daily; those allergic to doxycycline will instead receive cephalexin, 250 mg twice daily).

On evaluation by the Principal Investigator, patients with insufficient response to a two week course of doxycycline (continued CTCAE Grade 2 or higher rash) will begin therapy with low-dose acitretin (10 mg/day). Patients will continue to receive 10 mg/day acitretin and will be followed for 12 weeks, after which they will be treated off-study according to an individualized regimen agreed upon by the patient and treating oncologist.

Patients who continue to have unacceptable skin eruptions and who require off-study dose reduction or interruption of erlotinib despite acitretin treatment, as well as those patients who develop CTCAE Grade 3 or higher toxicity presumptively due to acitretin, will be considered non-responders for this study. These patients will be treated off-study.

Study of Acitretin to Treat Skin Rash Caused by Erlotinib (a Chemotherapy Drug)

Pilot Study of Acitretin for Treatment of Erlotinib-induced Skin Rash

Lesion counts of the identified area of worst involvement will be done in a 5x5 cm area. All subsequent measurements will be done in the same 5x5 cm area.

Lesion counts in area of worst involvement in 5x5 cm area

Lesion count is performed in the worst area of involvement in 5x5 cm area

Lesion count in the area of worst involvement in 5x5 cm area

Lesion count in area of worst involvement in 5x5 cm area

Standardized quality of life (QOL) tool will be used to assess impact of symptoms on QOL.

OSI Pharmaceuticals

University of Pittsburgh

Neoplasms

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

Neuroendocrine Tumor

Neuroepithelioma

Vemurafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

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

Carcinoma

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

acitretin

gene expression analysis

northern blotting

polymerase chain reaction

protein expression analysis

laboratory biomarker analysis

Mark R. Pittelkow, MD

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acitretin may stop cancer from growing in patients at high risk for basal cell carcinoma or squamous cell carcinoma of the skin.

PURPOSE: This randomized trial is studying how well acitretin works in preventing skin cancer in patients at high risk for skin cancer.

OBJECTIVES:

* Determine the chemopreventive efficacy of acitretin, a synthetic retinoid, in patients at high risk for basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
* Evaluate human papillomavirus (HPV) as a possible etiologic cofactor in the development of cutaneous epidermal dysplasia/carcinoma from skin tissues of patients at high risk for BCC or SCC of the skin.
* Determine the effect of acitretin on a series of potential surrogate endpoint biomarkers (SEBs), including specific retinoid receptors; the Fos/Jun family of proto-oncogenes and products; the Fos/Jun family of transcription factor complexes known as activating protein 1 (AP-1); and HPV DNA in normal (sun-protected), sun-exposed dysplastic and carcinoma (SCC/BCC) skin specimens.
* Correlate standard clinical and histopathological dermatologic evaluation with modulation of SEBs.

OUTLINE: This is a multicenter study. Patients are stratified according to age (18-49 years vs 50-59 years vs 60-69 years vs ≥ 70 years), number of skin cancers within the past 5 years (2-5 vs 6-10 vs 11-20 vs 21-30 vs \> 30), most recent skin cancer occurrence (\< 12 months ago vs ≥ 12 months ago), patient-reported sunburn susceptibility by Fitzpatrick skin type (1 vs 2 vs 3 vs 4 vs 5 vs 6), and assessment of visible skin damage (minimal vs moderate vs extensive). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral acitretin 5 days a week for 2 years in the absence of unacceptable toxicity.
* Arm II: Patients receive oral placebo 5 days a week for 2 years in the absence of unacceptable toxicity.

Tissue samples of normal skin, excised squamous cell or basal cell carcinoma, or excised actinic keratoses are obtained at baseline and periodically during study. Tissue samples are analyzed for surrogate endpoint biomarkers, including RARγ, RXRα, Fos/Jun family of proto-oncogenes and products, AP-1 DNA binding activity, and presence, identification, and quantification of HPV DNA. mRNA and protein expression levels of RARγ, RXRα, and Fos/Jun family members are analyzed by northern blotting and/or quantitative polymerase chain reaction (PCR) methods. HPV is analyzed by PCR.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

Acitretin in Preventing Skin Cancer in Patients at High Risk for Skin Cancer

Chemoprevention Trial of Acitretin Versus Placebo in Patients at High Risk for Basal Cell Carcinoma or Squamous Cell Carcinoma

National Cancer Institute (NCI)

Mayo Clinic

Mark R Pittelkow, M.D.

Patients receive oral acitretin daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies.

Patients are followed every 6 months.

Patients receive placebo daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies.

Patients are followed every 6 months.

placebo

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of acitretin may be an effective way to prevent the recurrence or further development of skin cancer.

PURPOSE: Randomized clinical trial to study the effectiveness of acitretin in preventing skin cancers in patients with at least two previously treated skin cancers who have undergone organ transplantation.

OBJECTIVES:

* Determine the chemopreventive efficacy of acitretin in immunosuppressed solid organ transplant recipients with a history of multiple previous basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) skin cancer resections.
* Evaluate human papillomavirus (HPV) as a possible etiologic cofactor in the development of cutaneous epidermal dysplasia/carcinoma from skin tissues of these patients.
* Determine the effect of acitretin on potential surrogate endpoint biomarkers and HPV DNA in normal (sun protected), sun-exposed, and dysplastic and carcinoma (SCC/BCC) skin specimens.

OUTLINE: This is a randomized study. Patients are stratified according to age (at least 18 to under 50 vs 50 to 59 vs 60 to 69 vs 70 and over), number of prior skin cancers in past 5 years (2 vs 3 vs at least 4), time since most recent skin cancer occurrence (less than 12 months vs at least 12 months), sunburn susceptibility (none vs moderate vs high), visible skin damage (mild vs moderate vs severe).

Patients receive either oral acitretin or placebo daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies.

Patients are followed every 6 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Acitretin to Treat Skin Rash Caused by Erlotinib (a Chemotherapy Drug)	NCT01299220	Skin Rash	Acitretin	18 Years -	University of Pittsburgh
A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma	NCT02050321	Malignant Melan...	Acitretin Vemurafenib	18 Years -	University of Arizona
Acitretin in Preventing Skin Cancer in Patients at High Risk for Skin Cancer	NCT00644384	Non-melanomatou...	acitretin gene expression... northern blotti... polymerase chai... protein express... laboratory biom...	18 Years -	Mayo Clinic
Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation	NCT00003611	Non-melanomatou...	acitretin placebo	18 Years -	Alliance for Clinical Trials in Oncology

Spots Global Cancer Trial Database for acitretin

Every month we try and update this database with for acitretin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for acitretin

Every month we try and update this database with for acitretin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for acitretin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.