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 |
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.
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.
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
121
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Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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5841 S Maryland Ave
Chicago, Illinois 60637
Chicago, Illinois 60637
1-773-702-6180
![University of Chicago Comprehensive Cancer Center](/wp-content/uploads/logos/university-of-chicago-comprehensive-cancer-center.png)
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dayton Children's - Dayton We have more than 290,000 reasons to make sure the care...
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Denver, Colorado 80218
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4760 Sunset Blvd
Downey, California 90027
Downey, California 90027
(323) 783-6151
![Southern California Permanente Medical Group](/wp-content/uploads/logos/southern-california-permanente-medical-group.png)
Southern California Permanente Medical Group We
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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900 West Faris Rd.
Greenville, South Carolina 29605
Greenville, South Carolina 29605
(864)455-8898
![BI-LO Charities Children's Cancer Center](/wp-content/uploads/logos/bi-lo-charities-children-s-cancer-center.jpg)
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Penn State Hershey Children's Hospital Penn State Milton S. Hershey Medical Center, Penn State College...
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1005 Joe DiMaggio Drive
Hollywood, Florida 33021
Hollywood, Florida 33021
954-265-JDCH (5324)
![Memorial Healthcare System - Joe DiMaggio Children's Hospital](/wp-content/uploads/logos/memorial-healthcare-system---joe-dimaggio-children-s-hospital.jpg)
Memorial Healthcare System - Joe DiMaggio Children's Hospital Since its inception in 1953, Memorial Healthcare...
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Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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601 South Rancho Drive
Suite C-26
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
(702) 384-0013
![Nevada Cancer Research Foundation CCOP](/wp-content/uploads/logos/nevada-cancer-research-foundation-ccop.gif)
Nevada Cancer Research Foundation CCOP The Nevada Cancer Research Foundation Community Clinical Oncology Program (NCRF-CCOP)...
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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Miller Children's Hospital Miller Children
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10833 Le Conte Ave
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-4321
![David Geffen School of Medicine, UCLA](/wp-content/uploads/logos/david-geffen-school-of-medicine-ucla.jpg)
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Midwest Children's Cancer Center The Medical College of Wisconsin Cancer Center is dedicated to providing...
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2450 Riverside Ave
Minneapolis, Minnesota 55454
Minneapolis, Minnesota 55454
(612) 273-3000
![University of Minnesota Medical Center, Fairview](/wp-content/uploads/logos/university-of-minnesota-medical-center-fairview.jpg)
University of Minnesota Medical Center, Fairview Improving patients' lives drives the innovation that makes University...
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2525 Chicago Ave
Minneapolis, Minnesota 55404
Minneapolis, Minnesota 55404
(612) 813-6000
![Children's Hospitals and Clinics of Minnesota - Minneapolis](/wp-content/uploads/logos/children-s-hospitals-and-clinics-of-minnesota---minneapolis.png)
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
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Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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One Robert Wood Johnson Place
New Brunswick, New Jersey 08901
New Brunswick, New Jersey 08901
(732) 828-3000
![UMDNJ-Robert Wood Johnson University Hospital](/wp-content/uploads/logos/umdnj-robert-wood-johnson-university-hospital.png)
UMDNJ-Robert Wood Johnson University Hospital Robert Wood Johnson University Hospital is a 965-bed hospital with...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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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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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 588-5912
![Tulane University Health Sciences Center](/wp-content/uploads/logos/tulane-university-health-sciences-center.jpg)
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
![University of Oklahoma Health Sciences Center](/wp-content/uploads/logos/university-of-oklahoma-health-sciences-center.png)
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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725 Welch Rd
Palo Alto, California 94304
Palo Alto, California 94304
(650) 497-8000
![Lucile Packard Children's Hospital Stanford University](/wp-content/uploads/logos/lucile-packard-children-s-hospital-stanford-university.jpg)
Lucile Packard Children's Hospital Stanford University Stanford Children's Health is the only network in the...
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Saint Joseph's Regional Medical Center Rich in history, St. Joseph's Healthcare System has evolved from...
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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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2801 N Gantenbein Ave
Portland, Oregon 97227
Portland, Oregon 97227
(503) 276-6500
![Randall Children's Hospital at Legacy Emanuel](/wp-content/uploads/logos/legacy-emanuel-children-s-hospital.png)
Legacy Emanuel Children's Hospital For generations our children's hospital has provided outstanding care for kids...
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