Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 29
Updated:6/10/2016
Start Date:October 2010
End Date:June 2015

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A Randomized Phase II Trial of Bevacizumab (Avastin) and Temsirolimus (Torisel) in Combination With Intravenous Vinorelbine and Cyclophosphamide in Patients With Recurrent/Refractory Rhabdomyosarcoma

This randomized phase II trial studies how well vinorelbine tartrate and cyclophosphamide
work in combination with bevacizumab or temsirolimus in treating patients with recurrent or
refractory rhabdomyosarcoma. Drugs used in chemotherapy, such as vinorelbine tartrate and
cyclophosphamide, work in different ways to stop the growth of tumor cells, either by
killing the cells or by stopping them from dividing. Monoclonal antibodies, such as
bevacizumab, 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 may also stop the growth of rhabdomyosarcoma by blocking
blood flow to the tumor. Temsirolimus may stop the growth of tumor cells by blocking some of
the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is
more effective when given together with bevacizumab or temsirolimus in treating
rhabdomyosarcoma.

PRIMARY OBJECTIVES:

l. To determine the feasibility of administering bevacizumab in combination with intravenous
vinorelbine (vinorelbine tartrate) and cyclophosphamide (VC) in patients with recurrent
rhabdomyosarcoma (RMS).

II. To determine the feasibility of administering temsirolimus in combination with VC in
patients with recurrent RMS.

III. To estimate the event-free survival (EFS) of patients with recurrent/refractory RMS
treated with bevacizumab and VC and compare with the EFS of those treated with temsirolimus
and VC.

SECONDARY OBJECTIVES:

I. To estimate the initial (2 cycle) response rate of patients with recurrent/refractory RMS
treated with bevacizumab and VC and compare with the response rate of those treated with
temsirolimus and VC, and to also compare the best response rate on each regimen of protocol
therapy.

II. To evaluate surrogate biological markers in patients with recurrent RMS and to estimate
differences in these markers following treatment with bevacizumab and temsirolimus.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive vinorelbine tartrate intravenously (IV) over 6-10 minutes on days 1
and 8 and cyclophosphamide IV over 30-60 minutes on day 1. Patients also receive bevacizumab
IV over 30-90 minutes on day 1.

ARM II: Patients receive vinorelbine tartrate and cyclophosphamide as in arm I. Patients
also receive temsirolimus IV over 30-60 minutes on days 1, 8, and 15.

In both arms, treatment repeats every 21 days for 12 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up annually for 5 years.

Inclusion Criteria:

- Diagnosis

- Patients with first relapse or progression of rhabdomyosarcoma are eligible

- Patients with primary refractory disease are eligible

- Primary refractory disease is defined as first progression after receiving
at least one course of cyclophosphamide or ifosfamide containing
chemotherapy without prior demonstration of a radiographic response to
chemotherapy (progression on irinotecan-containing chemotherapy without
cyclophosphamide or ifosfamide containing chemotherapy will not be
considered a first progression)

- Note: Patients without measurable or evaluable disease are eligible

- Patients must have had a previous histological verification of rhabdomyosarcoma at
original diagnosis

- Patients must have a Karnofsky or Lansky performance status score of >= 50%,
corresponding to Eastern Cooperative Oncology Group (ECOG) categories of 0, 1, or 2;
use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of
age

- Patients must have a life expectancy of >= 8 weeks

- Patients must have fully recovered from the acute toxic effects of all prior
chemotherapy, immunotherapy, or radiotherapy prior to entering this study

- Myelosuppressive chemotherapy: Must not have received within 3 weeks prior to entry
onto this study (4 weeks if prior nitrosourea)

- Biologic (anti-neoplastic agent):

- Patients may have received prior therapy with oral tyrosine kinase inhibitors or
other similar agents; at least 7 days must have elapsed since the completion of
therapy with a biologic agent and all toxicities must have resolved to < grade 2
prior to enrollment

- 3 half-lives (or 6 weeks) must have elapsed since previous monoclonal antibody
therapy prior to enrollment on this study

- Myeloid growth factor: Must not have received within 1 week prior to entry onto this
study

- Radiation therapy (RT): At least 4 weeks must have elapsed between RT and study
entry; previously radiated lesions cannot be used to assess response unless those
sites are the sites of disease progression

- Stem cell transplant (SCT): For autologous SCT, >= 3 months must have elapsed; for
allogeneic SCT, >= 6 months must have elapsed and no evidence of active graft vs.
host disease

- Patients must have recovered from any surgical procedure before enrolling on this
study

- Minor surgical procedures (e.g., biopsies involving core or fine-needle
aspiration procedures, infusaport or Broviac line placement, paracentesis, or
thoracocentesis) need to have fully healed and occurred > 7 days prior to
enrollment

- Patients who have had a major surgical procedure (such as laparotomy,
thoracotomy, open biopsy, or resection of tumor) can only be enrolled on study >
28 days from such procedure

- Peripheral absolute neutrophil count (ANC) >= 750/μL

- Platelet count >= 75,000/μL (transfusion independent, defined as without transfusion
for >= 1 week prior to enrollment)

- Hemoglobin >= 8.0 g/dL (may receive packed red blood cells [PRBC] transfusions)

- Bone marrow disease involvement of tumor is allowed, however, peripheral blood count
criteria must still be met

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows:

- =< 0.4 mg/dL (for patients aged 1 month to < 6 months)

- =< 0.5 mg/dL (for patients aged 6 months to < 1 year)

- =< 0.6 mg/dL (for patients aged 1 to < 2 years)

- =< 0.8 mg/dL (for patients aged 2 to < 6 years)

- =< 1 mg/dL (for patients aged 6 to < 10 years)

- =< 1.2 mg/dL (for patients aged 10 to < 13 years)

- =< 1.4 mg/dL (for female patients aged >= 13 years)

- =< 1.5 mg/dL (for male patients aged 13 to < 16 years)

- =< 1.7 mg/dL (for male patients aged >= 16 years)

- Urine protein level:

- Patients aged =< 17 years: Urine protein to creatinine (UPC) ratio should be
calculated; UPC ratio must be =< 1 for patient to be eligible

- Patients aged > 17 years: Urine protein should be screened by urine analysis; if
protein is 2+ or higher, 24-hour urine protein must be obtained and the level
must be < 1,000 mg for patient enrollment

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

- Shortening fraction of >= 27% by echocardiogram or ejection fraction of >= 50% by
radionuclide angiogram

Exclusion Criteria:

- Patients with botryoid histology, any stage or group, are ineligible

- Patients with embryonal histology, stage I or clinical group 1 at initial disease
presentation, who present with local or regional recurrence, are ineligible

- Patients who previously received craniospinal irradiation are ineligible

- Patients who previously received vinorelbine, bevacizumab, temsirolimus, or any other
direct vascular endothelial growth factor (VEGF)/vascular endothelial growth factor
receptor (VEGFR-) or mammalian target of rapamycin (mTOR-) targeting agents are
ineligible

- Patients with known central nervous system (CNS) disease (excluding
intracranial/intraspinal extension secondary to local progression of a parameningeal
or paraspinal primary), except for those with treated brain metastasis, are
ineligible

- Treated brain metastases are defined as having no ongoing requirement for
steroids and no evidence of progression or hemorrhage after treatment for at
least 3 months, as ascertained by clinical examination and brain imaging
(magnetic resonance imaging [MRI] or computed tomography [CT]); stable dose of
anticonvulsants are allowed; treatment for brain metastases may include
whole-brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear
accelerator [LINAC], or equivalent), or a combination as deemed appropriate by
the treating physician

- Patients with CNS metastases treated within 3 months prior to enrollment by
neurosurgical resection or brain biopsy are ineligible

- Patients who receive radiation or chemotherapy (inclusive of palliative intent) for
first disease progression or relapse of rhabdomyosarcoma prior to enrollment are
ineligible

- Female patients who are pregnant are ineligible

- Lactating females are not eligible unless they have agreed to discontinue
breastfeeding

- Female patients of childbearing potential are not eligible unless a negative
pregnancy test result has been obtained

- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation

- Patients with a documented chronic non-healing wound, ulcer, or significant trauma
injury (those with bone fractures, including pathological fractures, or requiring
surgical intervention) within 28 days prior to beginning therapy are ineligible

- Patients with evidence of intratumoral hemorrhage, gastrointestinal bleeding, or on
anticoagulation for thrombosis or history of thrombosis are ineligible

- Patients with uncontrolled hypertension are ineligible; uncontrolled hypertension is
defined as follows:

- Patients aged =< 17 years: greater than 95th percentile systolic and diastolic
blood pressure based on age and height that is not controlled by one
antihypertensive medication

- Patients aged > 17 years: systolic blood pressure >= 160 mm Hg and/or diastolic
blood pressure >= 90 mm Hg that is not controlled by one antihypertensive
medication

- Patients currently taking anticoagulants or antiplatelet agents with the exception of
aspirin (=< 81 mg/day) are ineligible

- Patients with history of central venous catheter (CVC)-associated thrombosis
requiring systemic anticoagulation are ineligible; Note: Patients with history of
sluggish flow from CVC or CVC-associated thrombosis treated with tissue plasminogen
activator (TPA) only are not excluded

- Patients with clinically significant cardiovascular disease are excluded:

- History of cerebrovascular accident (CVA) within the prior 6 months

- Myocardial infarction or unstable angina within the prior 6 months

- New York Heart Association grade 2 or greater congestive heart failure

- Serious and inadequately controlled cardiac arrhythmia

- Significant vascular disease (e.g., aortic aneurysm, history of aortic
dissection)

- Clinically significant peripheral vascular disease

- Patients diagnosed with rhabdomyosarcoma as a second malignant neoplasm are not
eligible

- Patients with history of any second malignant neoplasm who have received chemotherapy
or radiation for the treatment of that malignancy are not eligible
We found this trial at
164
sites
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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7777 Forest Ln # C840
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1200 Pleasant Street
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Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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1500 E Duarte Rd
Duarte, California 91010
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3300 Gallows Road
Falls Church, Virginia 22042
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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9981 S Healthpark Dr # 465
Fort Myers, Florida 33908
239-343-5000
Lee Memorial Health System Our origins can be traced to the Fall of 1916 when...
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
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Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
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Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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529 West Markham Street
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
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231 E Chestnut St
Louisville, Kentucky 40202
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4015 22nd Place
Lubbock, Texas 79410
806-725-0000
Covenant Children's Hospital Every child is different. And when they're sick or injured, they deserve...
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9300 Valley Children's Pl
Madera, California 93720
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Children's Hospital Central California The Children's Hospital Central California is a not-for-profit, state-of-the-art children’s hospital...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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747 52nd St
Oakland, California 94609
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1201 W La Veta Ave
Orange, California 92868
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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1717 South Orange Avenue # 100
Orlando, Florida 32806
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Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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593 Eddy Street
Providence, Rhode Island 02903
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
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40 Sunshine Cottage Road
Valhalla, New York 10595
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1600 Rockland Road
Wilmington, Delaware 19803
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Albany, New York 12208
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
(877) 475-6688
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Asheville, North Carolina 28801
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13123 E 16th Ave
Aurora, Colorado 80045
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2401 W Belvedere Ave
Baltimore, Maryland 21215
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
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489 State St
Bangor, Maine 04401
(207) 973-7000
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
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100 E Idaho St
Boise, Idaho 83712
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Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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55 Fruit St
Boston, Massachusetts 02114
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Boston, Massachusetts 02115
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charleston, West Virginia 25304
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Charlotte, North Carolina 28204
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Charlotte, North Carolina 28204
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Chattanooga, Tennessee 37403
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Chicago, Illinois 60614
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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1 Hospital Dr
Columbia, Missouri 65212
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
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100 North Academy Avenue
Danville, Pennsylvania 17822
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Dayton, Ohio 45404
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22101 Moross Rd
Detroit, Michigan 48236
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4160 John R St #2122
Detroit, Michigan 48201
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4760 Sunset Blvd
Downey, California 90027
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2301 Erwin Rd
Durham, North Carolina 27710
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East Lansing, Michigan 48824
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801 Broadway
Fargo, North Dakota 58102
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Fort Worth, TX
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835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
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Green Bay, WI
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Greenville, SC
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Greenville, South Carolina 29605
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Greenville, SC
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Children's Hospital Penn State Milton S. Hershey Medical Center, Penn State College...
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Hershey, PA
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Hollywood, FL
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Honolulu, Hawaii 96813
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Honolulu, HI
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Houston, Texas 77030
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Houston, TX
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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Indianapolis, Indiana 46260
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Indianapolis, IN
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Iowa City, IA
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Jacksonville, Florida 32207
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Jacksonville, FL
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Kalamazoo, Michigan 49008
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Kalamazoo, MI
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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Knoxville, TN
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601 South Rancho Drive Suite C-26
Las Vegas, Nevada 89106
(702) 384-0013
Nevada Cancer Research Foundation CCOP The Nevada Cancer Research Foundation Community Clinical Oncology Program (NCRF-CCOP)...
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Las Vegas, NV
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