このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Evaluation of Pathway Modulation by Raf, MEK, & Kinase Inhibitors

2019年1月3日 更新者:University of Arizona

Pilot Study to Evaluate the Signaling Pathway Modulation Demonstrated by Raf, MEK, and Kinase Inhibitors In Human Skin With or Without Solar Simulated Light

This is a pilot study designed to evaluate the cutaneous effect of systemic inhibition of the tyrosine kinase pathway in the presence or absence of solar simulated light exposure.

A maximum of 45 subjects will be accrued into the overall study we anticipate approximately 25 patients in the Raf inhibitor group and 10 patients each into the Tyrosine Kinase and MEK inhibitor arms of the study.

調査の概要

詳細な説明

The study will evaluate the modulatory effect of systemic Raf inhibition in the MEK/ERK and PI3 /Akt/mTOR pathways in patients undergoing targeted therapy for metastatic disease.

Changes in relevant proteins will be evaluated using a combined protein expression methodology that in includes immunohistochemistry (IHC) and reverse phase protein microarray (RPPA) technology.

The primary endpoint of this study will be assessed in normal skin and skin acutely exposed to solar simulated light

研究の種類

介入

入学 (予想される)

45

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Arizona
      • Tucson、Arizona、アメリカ、85724
        • University of Arizona Cancer Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Subjects who have not yet initiated but plan to undergo dosing with a Tyrosine Kinase inhibitor (TKI) or Raf inhibitor, either alone or with a MEK inhibitor, for treatment of metastatic melanoma, colon cancer, hepatic cell carcinoma, or thyroid cancer.
  • Individuals with normal skin and Fitzpatrick skin type II, III or IV.
  • Individuals who are willing to limit sun exposure to the body during the study period, and who agree to wear protective clothing and SPF 50 broad spectrum sunscreen or sunblock on exposed skin when they are outdoors.
  • Individuals who have the ability to understand and willingness to sign an informed consent before initiation of study procedures, after the nature of the study is explained to them and they have asked any questions.
  • Individuals with a Karnofsky Performance Status of at least 80%.

Exclusion Criteria:

  • Individuals with any inflammation or irritation of the skin at the test area (buttocks), or any skin conditions felt by the study physician to contraindicate enrollment.
  • Individuals with a history of any skin cancer, melanocytic lesions, actinic keratoses or actinic damage in the test area are ineligible. History of such conditions at a body site other than the test area is not exclusionary if in the opinion of the study physician it will not pose a risk to the subject.
  • Individuals who are immunosuppressed by virtue of medication or disease, as determined by the examining study physician. This includes AIDS patients and subjects taking oral steroids.
  • Individuals with active infection, psychiatric illness, or other situations that in the opinion of the study physician limit compliance or interfere with the study regimen.
  • Individuals with a history of photosensitive diseases including, but not limited to, Lupus Erythematosus, pseudoporphyria, or other diseases that in the opinion of the study physician would pose a risk to the subject or interfere with the study.
  • Individuals who have used photosensitizing drugs within the last 30 days prior to study enrollment, or who will be using a photosensitizing drug during the time of the study.
  • Individuals who have used any topical medication other than emollients on the test area within 30 days prior to study enrollment.
  • Individuals who have used retinoids, steroids, 5-fluorouracil, Levulan, Vaniqua (eflornithine), Solaraze, or Imiquimod (Aldara®) anywhere on the body within 30 days prior to enrollment.
  • Individuals must not take mega-doses of vitamins. Mega-doses are defined as more than 5 capsules of standard multivitamins daily or more than the Tolerable Upper Intake Levels of Vitamins, as defined by the Institute of Medicine, National Academy of Sciences. Such vitamin therapy must be discontinued at least 30 days prior to study entry.
  • Individuals with a history of natural or artificial sun exposure to the buttocks within 30 days of study participation.
  • Individuals with Fitzpatrick skin type I
  • Individuals with Fitzpatrick skin type V or VI
  • Individuals enrolled in or who plan to enroll in a clinical intervention trial. There must be a 30-day period between completing a previous study and enrolling in this study. The Principal Investigator will have the option to consider an exception for patients on drugs of interest for the purpose of this study.
  • Individuals with a known allergy to lidocaine.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:ArmA: With Solar Simulated Light Exposure
A Multiport UV Solar Simulator Model 600 (Solar Light Co., Inc., Philadelphia, PA) will be used to administer Solar Simulated Light (SSL) exposures to formerly unexposed buttock skin.The device is equipped with six 8mm liquid light guides (LLG), allowing for 6 simultaneously conducted exposures.A large 3x2 endplate places the LLGs several centimeters apart and is specifically designed for Sun Protection Factor (SPF) and photo patch testing. The dose of emission from each LLG can be precisely regulated and the spectrum of emission can be limited to UVA (320-390 nm) or UVB+UVA (290-390 nm). The operator can select between UVA only and a combined Ultraviolet-A (UVA)/ Ultraviolet-B (UVB) spectrum by placement of an optical filter. The spectral output (indicated below) follows the distribution of sunlight from 290 to 390 nm.
他の名前:
  • Multiport UV Solar Simulator Model 60
実験的:ArmB: With Solar Simulated Light Exposure (Vemurafenib/Dabraf)
Subjects in this study arm undergo the same procedures as Arm A, with the addition of a blood test for the presence of porphyrins
A Multiport UV Solar Simulator Model 600 (Solar Light Co., Inc., Philadelphia, PA) will be used to administer Solar Simulated Light (SSL) exposures to formerly unexposed buttock skin.The device is equipped with six 8mm liquid light guides (LLG), allowing for 6 simultaneously conducted exposures.A large 3x2 endplate places the LLGs several centimeters apart and is specifically designed for Sun Protection Factor (SPF) and photo patch testing. The dose of emission from each LLG can be precisely regulated and the spectrum of emission can be limited to UVA (320-390 nm) or UVB+UVA (290-390 nm). The operator can select between UVA only and a combined Ultraviolet-A (UVA)/ Ultraviolet-B (UVB) spectrum by placement of an optical filter. The spectral output (indicated below) follows the distribution of sunlight from 290 to 390 nm.
他の名前:
  • Multiport UV Solar Simulator Model 60
介入なし:ArmC: Without Solar Simulated Light Exposure

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Modulatory effect of systemic Raf inhibition in the MEK/Erk and PI3 /AKT/mTOR pathways in patients undergoing targeted therapy for metastatic disease
時間枠:2 months
The primary endpoint of the study is to evaluate the modulatory effect of systemic Raf inhibition in the MEK/Erk and PI3 /AKT/mTOR pathways in patients undergoing targeted therapy for metastatic disease. Changes in relevant proteins will be evaluated using a combined protein expression methodology that in includes immunohistochemistry (IHC) and reverse phase protein microarray (RPPA) technology. The primary endpoint of this study will be assessed in normal skin and skin acutely exposed to solar simulated light.
2 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Downstream modulation of direct Ras and MEK inhibition in human keratinocytes and melanocytes following acute solar simulated light exposure in the presence of metastatic disease treatment with Tyrosine kinase and MEK inhibitors.
時間枠:2 months
The modulatory effect will be evaluated using IHC and RPPA technology.
2 months
Modulatory effect of systemic Raf inhibition in the MEK/Erk and PI3 /AKT/mTOR pathways in eligible melanocytic nevi.
時間枠:2 months
2 months
Correlate the type and severity of cutaneous squamous cell carcinoma development in patients treated with BRaf inhibitors and the modulatory profile identified in the proposed primary endpoint.
時間枠:2 months
2 months
Safety of performing solar simulated light studies in patients undergoing Ras inhibition for metastatic disease.
時間枠:2 months
2 months
Modulatory effect of Ras inhibition in Epidermal Growth Factor Receptor (EGFR) and Activating Protein-1 (AP1) signaling pathways (IHC and RPPA).
時間枠:2 months
2 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Clara Curiel-Lewandroski、University of Arizona

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2014年10月17日

一次修了 (実際)

2018年11月1日

研究の完了 (実際)

2018年11月1日

試験登録日

最初に提出

2017年6月1日

QC基準を満たした最初の提出物

2017年6月1日

最初の投稿 (実際)

2017年6月5日

学習記録の更新

投稿された最後の更新 (実際)

2019年1月4日

QC基準を満たした最後の更新が送信されました

2019年1月3日

最終確認日

2019年1月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Solar Simulatorの臨床試験

購読する