Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Antineoplastic Agents

Dermatologic Agents

All Drugs and Chemicals

Tretinoin

Sunscreening Agents

Isotretinoin

Keratolytic Agents

Protective Agents

Radiation-Protective Agents

Oral isotretinoin 10mg/day for 6 months The dose could be reduced if there were any significant laboratory alterations or clinical adverse events, along with sunscreen FPS 60 every 3 hours during the day.

An every other night application of tretinoin 0,05% cream in the face and forearms for 6 months, along with sunscreen FPS 60 every 3 hours during the day.

If there were any clinical adverse events the drug could be reduced to twice a week.

Oral isotretinoin - 10mg/day (one pill) after lunch for six months

Oral isotretinoin

Topical tretinoin 0,05% cream - applied every other night in the face and forearms for six months

Tretinoin 0,05% cream

Sunscreen FPS 60 applied on sun exposed areas every 3 hours daily

Sunscreen FPS 60

Edileia Bagatin, MD, PhD

Hélio A Miot, MD, PhD

Actinic keratosis (AKs) are premalignant disorders that can evolve into skin cancer. To prevent their development, a study is being conducted with oral isotretinoin and topical tretinoin to verify what drug is the most effective and has the best security profile for these patients. Along with these treatments, cryotherapy with liquid nitrogen and sunscreens will be part of the treatment. The study will have the duration of 10 months. In the first four months, the AKs will be counted and treated with cryotherapy (face and arms) and sunscreens FPS 60 will be used. After it, the patients will return (the AKs will be counted), a new session of cryotherapy will be performed and they will be randomized into two groups: one group using oral isotretinoin 10mg/day ( ISO: 30 patients) and the other one using tretinoin 0,05% cream (AR: 30 patients) applied on face and arms. Skin biopsies will be done for all 60 patients at the beginning of the treatment with retinoids (isotretinoin and tretinoin). After six months of treatment with retinoids, the study will be stopped, AKs will be counted again and skin biopsies will be done. Patients in the group ISO (oral isotretinoin) also have to make blood tests at the beginning, two months and after six months of the treatment. Clinical (AK counting), histological (improvement of parts of the skin) and immunohistochemical parameters will be evaluated to see what drug is more effective for prevention of AKs.

This study is a randomized controlled trial with 60 men and women (already in menopause for at least one year), aged 50-75 years. At the beginning, the number of actinic keratosis (AKs) of face and forearms will be counted and treated with cryotherapy with liquid nitrogen (LN).The patients will be randomized in two groups: one receiving oral isotretinoin 10mg/day every day and other receiving tretinoin 0,05% cream applied in the face and arms every other night, for six months. Along with these treatments, patients will use sunscreens FPS 60 with UVA and UVB protection. The inclusion criteria will be the presence of at least 10 and maximum 40 AKs (visible or palpable). Skin biopsies will be performed twice (before and after treatment with retinoids) for all patients, in the left forearm at a standardized site. Histological and immunohistochemical with blinded- evaluator analysis will be done. The main objective of the study is to evaluate clinical, histological and immunohistochemical effects of retinoids for AK prevention on face and forearms of immunocompetent individuals. Efficacy evaluation will be measured by improving clinical (AK counting before and after treatments), histopathological (Hematoxilin-eosin and Verhoeff staining) and immunohistochemical parameters (markers for carcinogenesis - p53 protein, Bcl-2 and Bax). The secondary objective is evaluate the tolerability and safety of the drugs and their impact in quality of life. The safety analysis will be related to adverse events of the two drugs and the blood tests will be performed in the ISO group patients. Indirectly, by decreasing the number of AKs and the expression of cutaneous carcinogenesis markers, a decrease in the risk of squamous cell carcinoma could be infered . This principle is used by many drugs called chemoprophylactic drugs, and the retinoids are considered in this group.

Oral Isotretinoin Versus Topical Tretinoin for Actinic Keratosis

Low Dose Oral Isotretinoin Versus Topical Tretinoin for Prevention of Actinic Keratosis in Immunocompetent Patients: a Randomized, Comparative Trial

The Dermatology Life Quality Index (DLQI) questionnaire is performed for every patient at the time frames specified. With the reduction of actinic keratosis and use of retinoids it is expected for retinoids to reduce points of the questionnaire.

The clinical adverse events with tretinoin 0,05% cream are: erythema, burning sensation, desquamation, irritation The clinical adverse events with oral isotretinoin are: cheilitis, xerophthalmia, xerostomia, dry skin, epistaxis, and other mucocutaneous side effects

At day 120 (4 months) the patients of isotretinoin group (ISO) were submitted to laboratory tests: complete blood count, alanine and aspartate aminotransferase, fasting plasma glucose test and lipid profile tests.

At day 180 (6 months) the laboratory tests were repeated, except fasting plasma glucose test At day 300 (10 months) the laboratory tests were asked and repeated after 1 month, except fasting plasma glucose test

The actinic keratosis (AKs) will be counted by the same evaluator twice, in different moments at the same day, at the beginning of the study, after 4 months and at the end (10 months)

Skin biopsies will be taken from patients at the time of randomization (T120) and after the treatment with retinoids (T300) and stained with hematoxilin-eosin (HE)

Skin biopsies will be taken from patients at the time of randomization (T120) and after the treatment with retinoids (T300). Retinoids are known to reduce the expression of this marker of carcinogenesis.

Skin biopsies will be taken from patients at the time of randomization (T120) and after the treatment with retinoids (T300). Retinoids are known to increase the expression of this marker of carcinogenesis.

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Theraskin

Germed Pharma

Universidade Federal de Goias

Assistant Professor, MD, MsC

Rare Diseases

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Gaucher Disease Type 2

Neuroepithelioma

Anti-Infective Agents

Antibodies

Antibodies, Monoclonal

Molgramostim

Sargramostim

Immunomodulating Agents

Immunoglobulins

Carbamide Peroxide

Immunologic Factors

This is a single-arm, open label, open access study to provide the anti-GD2 murine IgG3 MoAb 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with high-risk neuroblastoma (NB). This immunotherapy has shown efficacy against minimal residual disease (MRD) in such patients.

Anti-GD2 3F8 Monoclonal Antibody

GM-CSF (granulocyte-macrophage colony-stimulating factor)

oral isotretinoin

Brian Kushner, MD

The purpose of this study is to be able to supply an experimental combination of drugs called 3F8 and GM-CSF (also called sargramostim) to patients with high-risk neuroblastoma who may benefit from treatment.

This treatment uses 3F8/GM-CSF and isotretinoin for: Group 1 patients are in 1st CR/VGPR; Group 2 patients are in a ≥2nd CR/VGPR; and Group 3 patients have primary refractory NB in BM. All patients will receive 3F8/GM-CSF through 24 months.

Road Map/Schema for Group 1 (1st CR/VGPR) and Group 2 (≥2nd CR/VGPR) patients:

Cycle 1 3F8 (iv) + GM-CSF subcutaneous (sc) (1 wk) 2-4-wk interval Cycle 2 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk interval\* - oral isotretinoin x14 days Cycle 3 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk interval - oral isotretinoin x14 days Cycle 4 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk interval - oral isotretinoin x14 days on, 14 days off, 14 days on Cycle 5 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk interval - oral isotretinoin x14 days on, 14 days off, 14 days on (6th cycle) Cycle 6 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk interval Cycle 7 3F8 (iv) + GM-CSF (sc) (1 wk) Continue with 6-8-wk intervals through 24 months from 1st dose of 3F8. \* assessment of BM status by standard histology

Road Map/Schema for Group 3 patients (BM positive): The break between end of a cycle of 3F8/GM-CSF and start of next cycle is approximately 2-to-4-weeks through 4 cycles after achievement of CR in BM; subsequent breaks are \~6-8 weeks. Please see roadmap below for a patient achieving CR in BM after cycle 1. Cycle 1 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk interval\* - BM negative Cycle 2 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk interval\* - oral isotretinoin x14 days Cycle 3 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk interval - oral isotretinoin x14 days Cycle 4 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk interval - oral isotretinoin x14 days Cycle 5 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk interval - oral isotretinoin x14 days Cycle 6 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk interval - oral isotretinoin x14 days on, 14 days off, 14 days on (6th cycle) Cycle 7 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk interval Continue with 6-8-wk intervals through 24 months from 1st dose of 3F8.

\* assessment of BM response by standard histology

Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma

Disease status is defined by the International Neuroblastoma Response Criteria - Complete response/remission (CR): NED; Partial response/remission: \>50% decrease in all disease parameters, exceptbone scan unchanged or improved; no more than 1 positive bone marrow site; Stable disease: \<50% decrease in all tumor markers; Progressive disease (PD): new lesion, or \>25 % increase in any disease marker.

Memorial Sloan Kettering Cancer Center

This is a single-arm, open label, open access study to provide the anti-GD2 murine IgG3 MoAb 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with high-risk neuroblastoma (NB). This immunotherapy has shown efficacy against minimal residual disease (MRD) in such patients.

Anti-GD2 3F8 Monoclonal Antibody

GM-CSF (granulocyte-macrophage colony-stimulating factor)

oral isotretinoin

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Isotretinoin Versus Topical Tretinoin for Actinic Keratosis	NCT02278861	Actinic Keratos...	Oral isotretino... Tretinoin 0,05%... Sunscreen FPS 6...	50 Years - 75 Years	Universidade Federal de Goias
Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma	NCT02100930	Neuroblastoma	Anti-GD2 3F8 Mo... GM-CSF (granulo... oral isotretino...	-	Memorial Sloan Kettering Cancer Center
Oral Isotretinoin Versus Topical Tretinoin for Actinic Keratosis	NCT02278861	Actinic Keratos...	Oral isotretino... Tretinoin 0,05%... Sunscreen FPS 6...	50 Years - 75 Years	Universidade Federal de Goias
Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma	NCT02100930	Neuroblastoma	Anti-GD2 3F8 Mo... GM-CSF (granulo... oral isotretino...	-	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for oral isotretinoin