Cyclophosphamide, Topotecan, and Bevacizumab (CTB) in Patients With Relapsed/Refractory Ewing's Sarcoma and Neuroblastoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT01492673
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide, Topotecan, and Bevacizumab — DRUG
    The treatment schedule for this study will consist of a 21-day cycle. Dose modification will only occur with administration of the investigational agent, bevacizumab. The schedule of administration is summarized as follows. Administration of bevacizumab will precede the administration of the cyclophosphamide and topotecan by 3 days (Day - 3) to allow for vascular stabilization prior to initiation of chemotherapy. The chemotherapy backbone will consist of cyclophosphamide and topotecan administered as follows: cyclophosphamide 250 mg/m2/day IV over 30 minutes ± 5 minutes on Days 0-4 followed by topotecan 0.75 mg/m2/day IV over 30 minutes ± 5 minutes on Day 0-4 of every cycle. The dosing of cyclophosphamide and topotecan will be fixed.

Study Details

The purpose of this study is to find out what effects, good and/or bad treatment with a new combination of drugs, cyclophosphamide, topotecan, and bevacizumab has on the patient and their cancer. The medications, cyclophosphamide and topotecan, are standard drugs often used together for the treatment of cancer in children with either Ewing's sarcoma or neuroblastoma. Bevacizumab is an experimental drug called an antibody that targets a protein important in the growth of cancer cells called vascular endothelial growth factor (VEGF). VEGF is made by tumor and other surrounding cells to help make blood vessels needed for the growth and spread of cancer cells in the body. The way that bevacizumab works is to stop the cancer cells from making their own blood supply, causing the tumor to stop growing bigger or from spreading. In adult clinical trials, bevacizumab has shown promising anti-cancer activity in patients with cancer of the colon/rectum (colorectal) and breast. It has been approved by the Food and Drug Administration (FDA) for use in patients with colorectal cancer but not in cancers found in children. Bevacizumab has been tested in early clinical studies in children and has been shown to be safe. Other goals of this study will include research tests designed to test the following changes in the patient or their cancer: to see how the body handles and breaks down bevacizumab (pharmacokinetics), to look at changes in proteins in the blood that may affect the way the cancer responds to the combination (angiogenic profile, angiogenesis associated serum biomarkers), to look at changes in genes that may affect how the cancer responds to treatment with this combination of medications (metabolic signature), and to monitor the effects of changes in the way the body grows and develops before and after bevacizumab is given.

Key Dates

First listed
Dec 15, 2011
Start date
Dec 31, 2011
Status verified
Oct 2018
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018

Study Design

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

Arms

  • Experimental: Cyclophosphamide, Topotecan, and Bevacizumab (CTB)
    This is a multi-center, open label phase II study evaluating the safety and efficacy of the novel combination of agents consisting of bevacizumab, cyclophosphamide, and topotecan.

Primary Outcome Measure

Objective Response Rate [ Time Frame: 2 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
Phoenix Children'S HospitalPhoenixArizona85016-
University of Colorado Health Sciences Center and The Children's HospitalDenverColorado80045-
MD Anderson Cancer Center Orlando at Arnold Palmer Hospital for ChildrenOrlandoFlorida32806-
Children's Mercy Hospital & ClinicsKansas CityMissouri64108-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Pennsylvania State University College of MedicineHersheyPennsylvania17110-

Find similar trials in Phoenix, AZ

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Phoenix Children'S Hospital· Phoenix, AZUniversity of Colorado Health Sciences Center and The Children's Hospital· Denver, COMD Anderson Cancer Center Orlando at Arnold Palmer Hospital for Children· Orlando, FLChildren's Mercy Hospital & Clinics· Kansas City, MOMemorial Sloan Kettering Cancer Center· New York, NYPennsylvania State University College of Medicine· Hershey, PA

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