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

28. april 2014 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

5

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Phase II Arm I
Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
Biologisk: bevacizumab
Gitt IV
Andre navn:
  • Avastin
  • anti-VEGF humanisert monoklonalt antistoff
  • anti-VEGF monoklonalt antistoff
  • rhuMAb VEGF
Aktiv komparator: 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.
Biologisk: bevacizumab
Gitt IV
Andre navn:
  • Avastin
  • anti-VEGF humanisert monoklonalt antistoff
  • anti-VEGF monoklonalt antistoff
  • rhuMAb VEGF
Legemiddel: etaracizumab
Given IV
Andre navn:
  • Abegrin
  • humanized monoclonal antibody MEDI-522
  • MEDI-522
  • monoclonal antibody anti-alpha V beta 3 integrin MEDI-522

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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)
Tidsramme: Up to 8 weeks
Up to 8 weeks
Progression-free Survival (Phase II)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute (NCI)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2008

Primær fullføring (Faktiske)

1. oktober 2010

Studiet fullført (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først innsendt

24. mai 2008

Først innsendt som oppfylte QC-kriteriene

24. mai 2008

Først lagt ut (Anslag)

28. mai 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. mai 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2014

Sist bekreftet

1. april 2013

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2009-01099 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • U10CA032102 (U.S. NIH-stipend/kontrakt)
  • CDR0000596555
  • S0717 (Annen identifikator: CTEP)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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