SARC016: Study of Everolimus With Bevacizumab to Treat Refractory Malignant Peripheral Nerve Sheath Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sarcoma Alliance for Research through Collaboration
Study ID
NCT01661283
Phase
PHASE2
Status
Completed

Conditions

  • MPNST
  • Malignant Peripheral Nerve Sheath Tumors
  • Sarcoma

Eligibility Criteria

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

Interventions

  • everolimus — DRUG
    10 mg tablet once daily
  • bevacizumab — DRUG
    10 mg/kg dose every 14 days

Study Details

To determine the clinical response rate of everolimus in combination with bevacizumab for patients with chemotherapy refractory sporadic or neurofibromatosis type 1 (NF1) associated malignant peripheral nerve sheath tumor (MPNST). To evaluate the toxicity and safety of everolimus in combination with bevacizumab in individuals with MPNST

Key Dates

First listed
Aug 9, 2012
Start date
Sep 30, 2012
Status verified
Feb 2019
Primary completion
Jun 30, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    All patients with MPNST will continue everolimus 10 mg daily and bevacizumab 10 mg/kg dose every 14 days

Primary Outcome Measure

Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease at ≥ 4 Months Using World Health Organization (WHO) Criteria) of Everolimus in Combination With Bevacizumab [ Time Frame: Assessed at Baseline and prior to Cycle 3, 5, 7, 9, etc., for up to 2 years. 1 cycle =28 days ]

Locations (12)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-0024-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Ann and Robert Lurie Children's Hospital of ChicagoChicagoIllinois60611-
University of IowaIowa CityIowa52242-
Johns HopkinsBaltimoreMaryland21218-
National Cancer InstituteBethesdaMaryland20892-1101-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Washington University in St. LouisSt LouisMissouri63130-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-3039-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Pennsylvania Oncology Hematology AssociatesPhiladelphiaPennsylvania19106-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALChildren's National Medical Center· Washington D.C., DCAnn and Robert Lurie Children's Hospital of Chicago· Chicago, ILUniversity of Iowa· Iowa City, IAJohns Hopkins· Baltimore, MDNational Cancer Institute· Bethesda, MD

Related Studies