Carfilzomib in Refractory Renal Cell Carcinoma (RCC)
Phase II Study of Carfilzomib in Patients With Refractory Renal Cell Carcinoma
The goal of this clinical research study is learn if carfilzomib can help control kidney cancer. The safety of this drug will also be studied.
Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die.
調査の概要
詳細な説明
Study Groups and Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive carfilzomib 2 days a week for the first 3 weeks of each 4-week study cycle (Days 1, 2, 8, 9, 15, and 16 of each cycle). Each dose is given by vein over about 30 minutes.
Before you receive the study drug, you will be given dexamethasone to help decrease the risk of side effects during the first cycle. You may ask the study staff for information about how the drugs are given and their risks.
During Cycle 1, you will receive extra fluid (saline) by vein before each dose of study drug. This is part of standard clinical care. This will also be done during Cycle 2, if the study doctor thinks it is needed.
You will remain in the clinic for an extra hour after receiving each dose during Cycle 1 and after the first dose of Cycle 2, to receive additional fluids by vein.
If you have any side effects from the drug, tell the study doctor right away. The study doctor may then lower the dose or keep the dose level the same.
Each study cycle is 4 weeks.
Study Visits:
Weeks 1, 2, and 3 of each cycle:
- Your vital signs and weight will be measured.
- Blood (about 3 teaspoons) will be drawn for routine tests
Every 4 weeks (+/-4 days):
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any drugs or treatments you may be receiving and any side effects that you have had.
- Your performance status will be recorded.
- Blood (about 3 teaspoons) will be drawn for routine tests and to check your blood sugar level and your pancreatic function, if the study doctor thinks it is needed. You will be asked to fast (not eat, and drink only water) for at least 8 hours before this blood draw.
Every 8 weeks (+/-7 days):
- You will have an x-ray of chest, CT scan of the chest and abdomen, and MRI scan of the brain to check the status of the disease. If the doctor thinks it is needed, you will also have a bone scan.
- If you can become pregnant, you will have a blood (about 2 teaspoons) pregnancy test.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, intolerable side effects occur, or you are not able to follow study directions.
End-of-Treatment Visit:
About 30 days after your last dose of the study drug:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any drugs or treatments you may be receiving and any side effects that you have had.
- Blood (about 3 teaspoons) will be drawn for routine and blood sugar tests.
- You will have an x-ray, CT scan, and MRI scan to check the status of the disease.
Long-Term Follow-up:
After you stop taking the study drug, the study staff will check your health status every 6 months for the rest of your life. The study staff will collect this information by either checking your medical record, emailing you, or calling you on the telephone. Each call should only last about 5 minutes.
This is an investigational study. Carfilzomib is FDA approved and commercially available in treatment of multiple myeloma. The use of carfilzomib in kidney cancer is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Texas
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Houston、Texas、アメリカ、77030
- University of Texas MD Anderson Cancer Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Biopsy proven clear cell kidney cancer with metastatic disease. Progressive disease or intolerance to at least one but not more than three (3) prior systemic therapy(ies)
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >/= 20 mm with conventional techniques or as >/= 10 mm with spiral CT scan.
- Age >/= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hepatic function with serum ALT and AST </= 3.0 times the upper limit of normal and serum direct and total bilirubin </= 1.5 times the upper limit of normal.
- Absolute neutrophil count (ANC) >/= 1.0 × 10^9/L; patients with an ECOG performance status of 2 at study entry must have an ANC >/= 1.5 x 10^9/L
- Hemoglobin >/= 8 g/dL (80 g/L) within 14 days prior to beginning study treatment (subjects may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines); Patients with an ECOG performance status of 2 at study entry must have a hemoglobin >/= 9 g/dL (transfusion assistance acceptable)
- Platelet count >/= 50 × 10^9/L; Patients with an ECOG performance status of 2 at study entry must have a platelet count >/= 100 × 10^9/L
- Creatinine clearance (CrCl) >/= 30 mL/minute, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
- Written informed consent in accordance with federal, local, and institutional guidelines.
- Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception during the study and for a period of 6 weeks after you stop receiving the study drug
- Male subjects must agree to practice contraception during the study and for a period of 6 weeks after you stop receiving the study drug
Exclusion Criteria:
- Brain metastases not controlled with surgery, whole brain radiotherapy, or with stereotactic radiosurgery
- Systemic therapy within two weeks of treatment initiation
- Pregnant or lactating females
- Major surgery within 21 days prior to beginning study treatment
- Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to beginning study treatment
- Known human immunodeficiency virus infection
- Active hepatitis B or C infection
- Unstable angina or myocardial infarction within 4 months prior to beginning study treatment, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
- Uncontrolled hypertension (defined by BP consistently > 150/100) or uncontrolled diabetes (defined by HbA1c > 8.5) within 14 days prior to beginning study treatment
- Nonhematologic malignancy within the past 2 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
- Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to beginning study treatment
- Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to beginning study treatment
- Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
研究計画
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:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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:Carfilzomib
Patients receive Carfilzomib at dose of 20 mg/m2 over 30 minutes by vein infusion on Days 1 and 2 and a dose of 56 mg/m2 over 30 minutes by vein infusion on Days 8, 9, 15, and 16 of each 4 week cycle.
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20 mg/m2 over 30 minutes by vein infusion on Days 1 and 2 and a dose of 56 mg/m2 over 30 minutes by vein infusion on Days 8, 9, 15, and 16 of each 4 week cycle.
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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 |
---|---|---|
Progression Free Survival (PFS) of Carfilzomib Therapy in Participants With Refractory Or Intolerant to Prior Therapy
時間枠:The number of months from enrollment to progression of cancer or death, whichever comes first up to 4 months
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Progression free survival defined as time from enrollment to progression or death, whichever comes first.
Progression defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Any patients who are alive and free of disease at time of analysis censored at date of most recent tumor assessment.
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The number of months from enrollment to progression of cancer or death, whichever comes first up to 4 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Overall Response Rate (ORR)
時間枠:Participants response was evaluated every 8 weeks from the first dose of carfilzomib until progression od disease (PD), up to 4 months
|
The number of participants had a complete response (CR, complete reduction in tumor burden) or partial response (PR, a reduction in tumor burden of at least 30%) as determined for radiographic imaging such as a CT scan.
Participants who do not have a reduction in tumor burden will either have stable disease (SD) or progressive disease (PD, which is an increase in tumor burden of at least 20%).
The results are based on the best response that each participant achieved while on treatment.
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Participants response was evaluated every 8 weeks from the first dose of carfilzomib until progression od disease (PD), up to 4 months
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Overall Survival (OS)
時間枠:15 months
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The number of months from the time of enrollment until death per participant
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15 months
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Safety of Carfilzomib
時間枠:4 months
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Reason for stopping therapy
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4 months
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PFS and ORR as a Function of VHL Mutation Subtype
時間枠:No data collected
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No data collected
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2012-0694
- NCI-2013-02350 (レジストリ識別子:NCI CTRP)
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
米国FDA規制機器製品の研究
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。
腎がんの臨床試験
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Carfilzomibの臨床試験
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Amgen完了肝障害 | 固形腫瘍 | 血液悪性腫瘍イギリス, オランダ, アメリカ, フランス
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Amgen完了多発性骨髄腫カナダ, デンマーク, フィンランド, フランス, イタリア, スペイン, スウェーデン, イギリス, チェコ, ポーランド, アメリカ, ベルギー, ハンガリー, ニュージーランド, オーストラリア, ドイツ, 日本, ギリシャ, ノルウェー, ルーマニア
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University of Alabama at BirminghamJanssen Scientific Affairs, LLC; Amgen完了
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AmgenInnovative Therapies For Children with Cancer Consortium; Therapeutic Advances in Childhood...積極的、募集していない急性リンパ芽球性白血病(ALL)スペイン, イギリス, アメリカ, 大韓民国, チェコ, フランス, ロシア連邦, サウジアラビア, タイ, カナダ, イタリア, シンガポール, 七面鳥, 台湾, ポルトガル, ポーランド, ルーマニア, ブラジル, オーストラリア, ギリシャ, アルゼンチン, メキシコ, オーストリア, チリ, オランダ, ノルウェー, コロンビア, スウェーデン, ブルガリア, デンマーク, 香港, イスラエル, 南アフリカ