Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01727089
Phase
PHASE2
Status
Completed

Conditions

  • Clear Cell Renal Cell Carcinoma
  • Recurrent Renal Cell Carcinoma
  • Stage IV Renal Cell Cancer
  • Type 1 Papillary Renal Cell Carcinoma
  • Type 2 Papillary Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anti-Endoglin Chimeric Monoclonal Antibody TRC105 — BIOLOGICAL
    Given IV
  • Bevacizumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This randomized phase II trial studies how well bevacizumab with or without anti-endoglin monoclonal antibody TRC105 (TRC105) works in treating patients with kidney cancer that has spread to other parts of the body (metastatic). Monoclonal antibodies, such as bevacizumab and anti-endoglin monoclonal antibody TRC105, may block tumor growth in different ways by targeting certain cells.

Key Dates

First listed
Nov 15, 2012
Start date
Nov 1, 2012
Status verified
Jul 2018
Primary completion
Aug 8, 2017
Completion
Aug 8, 2017

Study Design

Enrollment
59 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (bevacizumab)
    Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (bevacizumab, anti-endoglin monoclonal antibody TRC105)
    Patients receive bevacizumab as in Arm I and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival at 24 Weeks [ Time Frame: The duration of time from start of treatment to time of progression or death, assessed at 24 weeks ]

Locations (28)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
University of Colorado Cancer Center - Anschutz Cancer PavilionAuroraColorado80045-
University of ColoradoDenverColorado80217-3364-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
Moffitt Cancer CenterTampaFlorida33612-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Decatur Memorial HospitalDecaturIllinois62526-
NorthShore University HealthSystem-Evanston HospitalEvanstonIllinois60201-
NorthShore University HealthSystem-Glenbrook HospitalGlenviewIllinois60026-
Ingalls Memorial HospitalHarveyIllinois60426-
Fort Wayne Medical Oncology and Hematology Inc - Jefferson BoulevardFort WayneIndiana46804-
Fort Wayne Medical Oncology and Hematology Inc-ParkviewFort WayneIndiana46845-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
University of Maryland/Greenebaum Cancer CenterBaltimoreMaryland21201-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Mayo ClinicRochesterMinnesota55905-
Metro Minnesota Community Oncology Research ConsortiumSaint Louis ParkMinnesota55416-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-0850-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
M D Anderson Cancer CenterHoustonTexas77030-
Virginia Commonwealth University/Massey Cancer CenterRichmondVirginia23298-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CACity of Hope South Pasadena· South Pasadena, CAUniversity of Colorado Cancer Center - Anschutz Cancer Pavilion· Aurora, COUniversity of Colorado· Denver, CO

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