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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3333 Burnet Avenue # Mlc3008
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529 West Markham Street
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9300 Valley Children's Pl
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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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601 Children's Lane
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1717 South Orange Avenue # 100
Orlando, Florida 32806
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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Saint Jude Midwest Affiliate The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic was...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
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Pittsburgh, Pennsylvania 15224
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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
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Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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280 W MacArthur Blvd,
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750 East Adams Street
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8901 Rockville Pike
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Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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171 Ashley Avenue
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3110 MacCorkle Ave. S.E.
Charleston, West Virginia 25304
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225 E Chicago Ave
Chicago, Illinois 60611
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Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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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
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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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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
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BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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1005 Joe DiMaggio Drive
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10833 Le Conte Ave
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2450 Riverside Ave
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Minneapolis, Minnesota 55454
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Minneapolis, Minnesota 55404
Minneapolis, Minnesota 55404
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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
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New Brunswick, New Jersey 08901
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UMDNJ-Robert Wood Johnson University Hospital Robert Wood Johnson University Hospital is a 965-bed hospital with...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
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Palo Alto, California 94304
Palo Alto, California 94304
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2801 N Gantenbein Ave
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Portland, Oregon 97227
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