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Bevacizumab With or Without MEDI-522 in Treating Patients With Unresectable or Metastatic Kidney Cancer

28. dubna 2014 aktualizováno: National Cancer Institute (NCI)

A Phase I and a Randomized Phase II Study of Maximal Angiogenic Blockade in Advanced Renal Carcinoma: Bevacizumab (NSC-704865) With or Without MEDI-522 (NSC-719850)

This phase I/randomized phase II trial is studying the side effects and best dose of bevacizumab and to see how well it works when given together with or without MEDI-522 in treating patients with unresectable or metastatic kidney cancer. Monoclonal antibodies, such as bevacizumab and MEDI-522, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab and MEDI-522 may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective when given together with or without MEDI-522 in treating kidney cancer.

Přehled studie

Postavení

Ukončeno

Podmínky

Intervence / Léčba

Detailní popis

PRIMARY OBJECTIVES:

I. To assess the appropriate dose of bevacizumab when administered with humanized monoclonal antibody MEDI-522 in patients with unresectable or metastatic renal cell carcinoma previously treated with sunitinib malate or sorafenib tosylate. (Phase I) II. To compare the progression-free survival of these patients treated with bevacizumab with versus without humanized monoclonal antibody MEDI-522. (Phase II) III. To evaluate the qualitative and quantitative toxicities of bevacizumab and humanized monoclonal antibody MEDI-522 in these patients. (Phase II) IV. To estimate overall survival and RECIST response rate (i.e., confirmed and unconfirmed, complete and partial responses) in both treatment arms. (Phase II)

OUTLINE: This is a multicenter, phase I, dose-escalation study of bevacizumab followed by a randomized phase II study.

PHASE I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.

PHASE II: Patients are stratified according to the number of prior treatment regimens for renal cell carcinoma (1 vs 2) and whether there is a clear cell component (yes vs no). Patients are randomized to 1 of 2 treatment arms:

ARM I: Patients receive bevacizumab (10 mg/kg) IV over 30-90 minutes on days 1 and 15.

ARM II: Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8 mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for up to 3 years.

Typ studie

Intervenční

Zápis (Aktuální)

5

Fáze

  • Fáze 2
  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • California
      • Marysville, California, Spojené státy, 95901
        • Fremont - Rideout Cancer Center
      • Sacramento, California, Spojené státy, 95817
        • University of California at Davis Cancer Center
    • Michigan
      • Ann Arbor, Michigan, Spojené státy, 48109
        • University of Michigan
    • North Carolina
      • Charlotte, North Carolina, Spojené státy, 28204
        • Novant Health Presbyterian Medical Center
    • Oregon
      • Portland, Oregon, Spojené státy, 97239
        • SWOG

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Criteria:

  • Histologically or cytologically confirmed renal cell carcinoma
  • Metastatic or unresectable disease
  • Must have received prior sunitinib malate or sorafenib tosylate for metastatic or unresectable disease
  • Measurable disease
  • No soft tissue disease that has been irradiated within the past 2 months
  • More than 6 months since prior and no concurrent treated or untreated brain metastases
  • Stable, treated brain metastases allowed provided they remained stable for more than 6 months
  • Patients with clinical evidence of brain metastases must have a negative brain CT or MRI scan for metastatic disease
  • Zubrod performance status 0-1
  • Urine protein:creatinine ratio =< 0.5 OR urine protein < 1,000 mg by 24-hour collection
  • Not be pregnant or nursing
  • Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy
  • No serious or non-healing wound, ulcer, or bone fracture
  • No clinically relevant bleeding diathesis or coagulopathy
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No significant traumatic injury within the past 28 days
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No other prior malignancy, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
  • No New York Heart Association class II-IV congestive heart failure
  • No unstable symptomatic arrhythmia requiring medication
  • Chronic, controlled arrhythmias (e.g., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
  • None of the following cardiovascular conditions within the past 6 months: Arterial thrombosis, Unstable angina, Myocardial infarction, Cerebrovascular accident
  • Must have controlled blood pressure, defined as systolic blood pressure (BP) =< 160 mm Hg and/or diastolic BP =< 90 mm Hg
  • More than 7 days since prior core biopsy
  • At least 14 days since completion of prior therapy and recovered
  • At least 28 days since prior radiotherapy and recovered
  • No prior radiotherapy to >= 25% of bone marrow
  • No more than two prior systemic regimens for renal cell carcinoma (including adjuvant treatment)
  • No prior bevacizumab or humanized monoclonal antibody MEDI-522
  • No major surgical procedure or open biopsy within the past 28 days
  • No concurrent need for a major surgical procedure
  • Concurrent full-dose anticoagulation with warfarin allowed provided INR is between 2-3
  • Concurrent low molecular weight heparin allowed
  • No clinically significant vascular disease (e.g., aortic aneurysm or history of aortic dissection)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Phase II Arm I
Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
Biologický: bevacizumab
Vzhledem k tomu, IV
Ostatní jména:
  • Avastin
  • anti-VEGF humanizovaná monoklonální protilátka
  • anti-VEGF monoklonální protilátka
  • rhuMAb VEGF
Aktivní komparátor: Phase II Arm II
Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
Biologický: bevacizumab
Vzhledem k tomu, IV
Ostatní jména:
  • Avastin
  • anti-VEGF humanizovaná monoklonální protilátka
  • anti-VEGF monoklonální protilátka
  • rhuMAb VEGF
Lék: etaracizumab
Given IV
Ostatní jména:
  • Abegrin
  • humanized monoclonal antibody MEDI-522
  • MEDI-522
  • monoclonal antibody anti-alpha V beta 3 integrin MEDI-522

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Maximum Tolerated Dose of Bevacizumab , Based on Incidence of Dose-limiting Toxicity (DLT) Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)
Časové okno: Up to 8 weeks
Up to 8 weeks
Progression-free Survival (Phase II)
Časové okno: From date of registration to date of first observation of progressive disease, systemic deterioration, or death due to any cause, assessed up to 3 years
Measured from date of registration to date of first observation of progressive disease, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
From date of registration to date of first observation of progressive disease, systemic deterioration, or death due to any cause, assessed up to 3 years
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 (Phase II)
Časové okno: Up to 3 years
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Up to 3 years
Overall Survival (Phase II)
Časové okno: From date of registration to date of death due to any cause, assessed up to 3 years
Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
From date of registration to date of death due to any cause, assessed up to 3 years
Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST), Including Confirmed and Unconfirmed Complete and Partial Responses (Phase II)
Časové okno: Up to 3 years
Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of nonmeasurable disease. No new lesions.
Up to 3 years

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Časové okno: Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National Cancer Institute (NCI)

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. června 2008

Primární dokončení (Aktuální)

1. října 2010

Dokončení studie (Aktuální)

1. října 2010

Termíny zápisu do studia

První předloženo

24. května 2008

První předloženo, které splnilo kritéria kontroly kvality

24. května 2008

První zveřejněno (Odhad)

28. května 2008

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

15. května 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. dubna 2014

Naposledy ověřeno

1. dubna 2013

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • NCI-2009-01099 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
  • U10CA032102 (Grant/smlouva NIH USA)
  • CDR0000596555
  • S0717 (Jiný identifikátor: CTEP)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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