Study of Muscle Energy Metabolism in RCC Patients Treated With Sunitinib
Evaluation of Technetium-99m Sestamibi to Determine Muscle Energy Metabolism in RCC (Renal Cell Cancer) Patients Treated With Sunitinib
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Descrizione dettagliata
Tipo di studio
Tipo di studio
Contatti e Sedi
Luoghi di studio
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Signed informed consent before any study procedures completed
- Patients must have histologically or cytologically confirmed RCC.
- Four weeks must have elapsed since prior chemotherapy, hormonal therapy, targeted therapy or radiation therapy. There is no restriction on the amount of bone marrow previously radiated.
- Recovery to baseline or, at most, grade 1 of all drug-related toxicities due to prior chemotherapy, radiation, hormonal therapy, or molecular targeted therapy, expect for alopecia.
- Male / female subject ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status of <2 (Karnofsky >70%)
- Life expectancy of at least 12 weeks
Normal organ and marrow function as defined by :
- absolute neutrophil count (ANC) > 1500/mcL
- hemoglobin (Hb) > 90 g/L
- platelet count ≥ 1000.000/mcL,
- total bilirubin ≤ 1.5 x the upper limit of normal range (ULN)
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN (<5 x ULN presence of liver metastases)
- creatinine < 1.5 x institutional ULN
- Cardiac ejection fraction by MUGA scan or echocardiogram must be >50% for patients at baseline.
- Ability to understand the purpose of the study and the willingness to sign a written informed consent document
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Standard Nuclear Medicine department pregnancy screening will be conducted prior to each 99mTc-sestamibi scan. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. The investigator is requested to advise the patient how to achieve an adequate contraception.
- Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
Exclusion Criteria:
- Patients who have had chemotherapy, hormonal therapy, molecular targeted therapy, or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients may not be receiving any other investigational agents, chemotherapy, immunotherapy, radiotherapy, or molecular targeted agents.
- Prior treatment with a drug with known anti-angiogenic properties, including other tyrosine kinase inhibitors to VEGFR
- Any psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, HIV, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients that are on therapeutic dose of coumadin or an INR of 1.5 c ULN. Patients that are on low dose coumadin (2mg or less for patency of the central venous catheter) or therapeutic dose of low molecular weight heparin will be allowed.
- Patients who cannot swallow
- Patients who are breast-feeding.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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99mTc-sestamibi uptake in muscle cells
Lasso di tempo: 12 weeks from start of treatment
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12 weeks from start of treatment
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99mTc-sestamibi uptake in muscle cells
Lasso di tempo: 24 weeks from start of treatment
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24 weeks from start of treatment
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99mTc-sestamibi uptake in muscle cells
Lasso di tempo: 36 weeks from start of treatment
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36 weeks from start of treatment
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Incidence of sunitinib related fatigue
Lasso di tempo: 36 weeks after the start of sunitinib treatment
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36 weeks after the start of sunitinib treatment
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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Michael Sawyer, MD, Alberta Health Services
Studiare le date dei record
Studia le date principali
Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- Sestamibi 1.0
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