Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 49
Updated:1/1/2014
Start Date:January 2010

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A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab [IMC-A12, Anti-IGF-IR Monoclonal Antibody, IND #100947, NSC #742460]) in Combination With Intensive Multi-Agent Interval Compressed Therapy for Patients With High-Risk Rhabdomyosarcoma

This clinical trial is studying the side effects and how well giving temozolomide and
cixutumumab together with combination chemotherapy works in treating patients with
metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide, 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 cixutumumab, 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. Giving temozolomide and
cixutumumab together with combination chemotherapy may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To determine the feasibility of administering cixutumumab in combination with an
intensive multi-agent interval compressed chemotherapy regimen for the treatment of
high-risk metastatic rhabdomyosarcoma (RMS).

II. To determine the feasibility of adding temozolomide to vincristine and irinotecan in
these patients.

III. To assess immediate and short-term side effects of concurrent temozolomide,
vincristine, and irinotecan with radiotherapy in these patients.

SECONDARY OBJECTIVES:

I. To gain a preliminary estimate of the response rate to cixutumumab or temozolomide,
vincristine, and irinotecan in these patients.

II. To obtain preliminary efficacy data for cixutumumab or temozolomide in combination with
an intensive multi-agent interval compressed chemotherapy regimen in these patients.

III. To determine the effectiveness of detecting metastatic disease with fludeoxyglucose F
18 positron emission tomography (FDG PET) and to compare assessment of response using
standard imaging techniques with response assessed by FDG PET.

IV. To assess changes in serum levels of insulin-like growth factor (IGF)-I, IGF-II, IGF-BP3
as biomarkers of IGF-IR inhibition.

OUTLINE: This is a dose-escalation study of cixutumumab. Patients are assigned to 1 of 2
treatment groups according to the timing of their enrollment onto the study.

GROUP 1: Patients receive vincristine sulfate intravenously (IV) on day 1 of weeks 1-5, 7,
8, 11, 12, 15, 16, 20-24, 28, 29, 32, 33, 35, 38, 41-44, 47, 48, 50, and 51; irinotecan
hydrochloride IV over 90 minutes on days 1-5 of weeks 1, 4, 20, 23, 47, and 50; ifosfamide
IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 9, 13, 17, 26, and 30;
doxorubicin hydrochloride IV on days 1 and 2 of weeks 7, 11, 15, 28, and 32;
cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41, and
44; dactinomycin IV on day 1 of weeks 35, 38, 41, and 44; and cixutumumab IV over 1 hour on
day 1 of weeks 1-51. Patients also undergo radiotherapy* on days 1-5 of weeks 20-24.

GROUP 2: Patients receive vincristine sulfate, irinotecan hydrochloride, ifosfamide,
etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin and undergo
radiotherapy* as in group 1. Patients also receive temozolomide orally (PO) on days 1-5 of
weeks 1, 4, 20, 23, 47, and 50.

GROUP 3: Patients receive vincristine sulfate, irinotecan hydrochloride, ifosfamide,
etoposide, doxorubicin hydrochloride, cyclophosphamide, dactinomycin, and cixutumumab and
undergo radiotherapy* as in group 1. Patients also receive temozolomide as in group 2.
(Discontinued as of January 2013)

NOTE: *Patients with parameningeal tumors and evidence of intracranial extension or those
requiring emergency radiotherapy may receive radiotherapy starting in week 1; cixutumumab
should be withheld during radiotherapy.

After completion of study therapy, patients are followed up periodically for up to 10 years.

Inclusion Criteria:

- Newly diagnosed, biopsy-confirmed metastatic rhabdomyosarcoma (RMS) or
ectomesenchymoma

- Stage IV, Clinical Group IV

- RMS with parameningeal and paraspinal primary tumors, including those with
intracranial extension by contrast magnetic resonance imaging (MRI) showing that the
primary tumor touches, displaces, invades, distorts, or otherwise causes signal
abnormality of the dura in brain or spinal cord in contiguity to the primary site,
are allowed; ICE is also presumed to exist if the cerebrospinal fluid (CSF)
cytopathology is positive for tumor at diagnosis

- Has undergone initial surgery (including biopsy) that provided the definitive
diagnosis within the past 42 days

- Enrollment on COG-D9902 required

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

- Absolute neutrophil count (ANC) >= 750/μL

- Abnormal blood counts are permissible if there is bone marrow biopsy or aspirate
proven bone marrow involvement by RMS

- Platelet count >= 75,000/μL

- Abnormal blood counts are permissible if there is bone marrow biopsy or aspirate
proven bone marrow involvement by RMS

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

- 0.4 mg/dL (for patients 1 to 5 months of age)

- 0.5 mg/dL (for patients 6 to 11 months of age)

- 0.6 mg/dL (for patients 1 year of age)

- 0.8 mg/dL (for patients 2 to 5 years of age)

- 1.0 mg/dL (for patients 6 to 9 years of age)

- 1.2 mg/dL (for patients 10 to 12 years of age)

- 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)

- 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients >= 16 years of age)

- Patients with urinary tract obstruction by tumor must meet the renal function
criteria listed above AND must have unimpeded urinary flow established via
decompression of the obstructed portion of the urinary tract

- Total bilirubin =< 1.5 times upper limit of normal (ULN) for age (unless there is
evidence of biliary obstruction by the tumor)

- Shortening fraction >=≥ 27% by echocardiogram (ECHO) OR ejection fraction >= 50% by
radionuclide angiogram

- Not pregnant or nursing

- Negative pregnancy test

- Sexually active patients of childbearing potential must agree to use effective
contraception during therapy (groups1 and 2) and for at least 3 months after the last
dose of cixutumumab (group 1)

- No uncontrolled infection

- No known type I or type II diabetes mellitus (for patients enrolled in group 1)

- No prior chemotherapy or radiotherapy except corticosteroids or emergent radiotherapy

- Patients requiring emergency radiation are eligible

- No concurrent growth hormone therapy

- All patients and/or their parents or legal guardians must sign a written informed
consent
We found this trial at
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2213 Cherry Street
Toledo, Ohio 43608
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1 Perkins Square
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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3400 N Charles St
Baltimore, Maryland 21205
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
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Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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1600 7th Avenue
Birmingham, Alabama 35233
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1720 2nd Ave S
Birmingham, Alabama 35233
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85 S Prospect St
Burlington, Vermont 5405
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1000 Blythe Blvd
Charlotte, North Carolina 28203
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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700 Childrens Drive
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530 Northeast Glen Oak Avenue
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Pittsburgh, Pennsylvania 15224
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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60 Crittenden Blvd # 70
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280 W MacArthur Blvd,
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501 6th Ave S
Saint Petersburg, Florida 33701
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3020 Childrens way
San Diego, California 92123
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750 East Adams Street
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1600 Rockland Road
Wilmington, Delaware 19803
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Charleston, South Carolina 29425
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Dayton, Ohio 45404
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Minneapolis, Minnesota 55454
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Minneapolis, Minnesota 55404
(612) 813-6000
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
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Minneapolis, MN
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100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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Morristown, NJ
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One Robert Wood Johnson Place
New Brunswick, New Jersey 08901
(732) 828-3000
UMDNJ-Robert Wood Johnson University Hospital Robert Wood Johnson University Hospital is a 965-bed hospital with...
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New Brunswick, NJ
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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New Hyde Park, NY
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200 Henry Clay Avenue
New Orleans, Louisiana 70118
(504) 899-9511
Children's Hospital-Main Campus Children's Hospital is a 247-bed, not-for-profit medical center offering the most advanced...
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New Orleans, LA
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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New Orleans, LA
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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New York, NY
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Newark, NJ
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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725 Welch Rd
Palo Alto, California 94304
(650) 497-8000
Lucile Packard Children's Hospital Stanford University Stanford Children's Health is the only network in the...
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Palo Alto, CA
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703 Main Street
Paterson, New Jersey 07503
973.754.2000
Saint Joseph's Regional Medical Center Rich in history, St. Joseph's Healthcare System has evolved from...
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Paterson, NJ
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Phoenix, AZ
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