- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00462982
Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma
A Phase II Study of SU11248 (Sunitinib) in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with brain metastases caused by kidney cancer or melanoma.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
Primary
- Determine the efficacy of sunitinib malate, in terms of objective radiographic response of brain lesions, in patients with brain metastases secondary to renal cell carcinoma or melanoma.
Secondary
- Determine overall and progression-free survival.
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
New York
-
New York, New York, Stati Uniti, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma or renal cell carcinoma
- Metastatic brain disease
Must have assessable target intracranial lesion(s), defined as measurable disease ≥ 10 mm in longest diameter that is not appropriate for stereotactic radiosurgery or surgical resection
Lesions previously treated with radiosurgery AND not eligible for resection can only be used as target lesions if there has been true tumor progression on baseline scan (i.e., ≥ 20% increase in longest diameter of lesion) rather than radionecrosis
- True progression must be confirmed by PET scan or other corroborating imaging used to distinguish radionecrosis
- No leptomeningeal metastases or primary dural metastases
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Total leukocyte count ≥ 3,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 2.0 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Hemoglobin ≥ 9.0 g/dL
- Calcium ≤ 12.0 mg/dL
- AST and ALT ≤ 1.5 times ULN
- PT ≤ 1.5 times ULN
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No uncontrolled medical illness including, but not limited to, any of the following:
- Hypertension (i.e., blood pressure > 150/100 mm Hg)
- Thyroid disease
- Severe valvular disease
- Severe pulmonary disease
- HIV/AIDS
- Severe psychiatric illness
- No cardiac dysrhythmia ≥ grade 2
- No prolonged QTc interval on baseline EKG
No systemic hemorrhage ≥ grade 2 within the past 4 weeks
No CNS hemorrhage ≥ grade 2
- Grade 1 (asymptomatic) CNS hemorrhage allowed at investigator's discretion
None of the following within the past 6 months:
- Myocardial infarction
- Unstable angina
- Symptomatic congestive heart failure
- Stroke/transient ischemic attack
- Pulmonary embolism
- Ejection fraction ≥ 50% by baseline echocardiogram OR < 20% decrease in ejection fraction from a prior study
PRIOR CONCURRENT THERAPY:
- No prior multi-targeted tyrosine kinase inhibitor therapy (e.g., sunitinib malate or sorafenib)
- No coronary/peripheral arterial bypass surgery within the past 6 months
- More than 4 weeks since prior surgery and recovered
- More than 4 weeks since prior and no other concurrent experimental therapy or cytotoxic chemotherapy
- More than 4 weeks since prior immunotherapy
- More than 2 weeks since prior stereotactic radiosurgery and recovered
- More than 7 days since prior and no concurrent drugs that interact with CYP3A4 family, including enzyme-inducing antiepileptic drugs, warfarin, or Hypericum perforatum extract (St. John's wort)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Sunitinib
Patients will be treated with 50 mg daily for four out of every six weeks.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Central Nervous System (CNS) Response Rate by RECIST Criteria
Lasso di tempo: up to a year
|
Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST.
Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, X-ray) or as >10 mm with spiral CT scan.
This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality.
All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters).
All other lesions are considered non-measurable disease.
Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable.
|
up to a year
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Paul B. Chapman, MD, Memorial Sloan Kettering Cancer Center
- Investigatore principale: Lauren E. Abrey, MD, Memorial Sloan Kettering Cancer Center
- Investigatore principale: Robert J. Motzer, MD, Memorial Sloan Kettering Cancer Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie urologiche
- Neoplasie urogenitali
- Neoplasie per sede
- Malattie renali
- Malattie urologiche
- Adenocarcinoma
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Tumori neuroectodermici
- Neoplasie, cellule germinali ed embrionali
- Neoplasie, tessuto nervoso
- Tumori neuroendocrini
- Nevi e melanomi
- Neoplasie renali
- Carcinoma, cellule renali
- Melanoma
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Inibitori della chinasi proteica
- Sunitinib
Altri numeri di identificazione dello studio
- 07-009
- P30CA008748 (Sovvenzione/contratto NIH degli Stati Uniti)
- MSKCC-07009
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .