Clinical Trial - NCT02867592

Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors

Recruiting

Sponsor: National Cancer Institute (NCI)

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02867592

Protocol Info

Short Description: XL184 IN SARCOMAS, WILMS TUMOR, AND OTHER RARE TUMORS
Long Description: Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors
MGH Status: Open
Sponsor: Coop/COG
Disease Program: Pediatrics

Next Steps


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Purpose

This phase II trial studies how well cabozantinib-s-malate works in treating younger patients with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth and tumor blood vessel growth.
Condition Title Intervention Phase
Adrenal Cortex Carcinoma Alveolar Soft Part Sarcoma Central Nervous System Neoplasm Childhood Clear Cell Sarcoma of Soft Parts Clear Cell Sarcoma of Soft Tissue Ewing Sarcoma Hepatoblastoma Hepatocellular Carcinoma MITF Positive Osteosarcoma Recurrent Adrenal Cortex Carcinoma Recurrent Alveolar Soft Part Sarcoma Recurrent Ewing Sarcoma Recurrent Hepatoblastoma Recurrent Hepatocellular Carcinoma Recurrent Malignant Central Nervous System Neoplasm Recurrent Malignant Solid Neoplasm Recurrent Osteosarcoma Recurrent Renal Cell Carcinoma Recurrent Rhabdomyosarcoma Recurrent Soft Tissue Sarcoma Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma Recurrent Thyroid Gland Medullary Carcinoma Refractory Ewing Sarcoma Refractory Malignant Central Nervous System Neoplasm Refractory Malignant Solid Neoplasm Refractory Osteosarcoma Refractory Rhabdomyosarcoma Refractory Soft Tissue Sarcoma Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma Renal Cell Carcinoma Rhabdomyosarcoma Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma Solid Neoplasm Thyroid Gland Medullary Carcinoma Wilms Tumor Cabozantinib Cabozantinib S-malate Pharmacological Study Phase 2
Study Type Interventional
Official Title Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults With Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors

Primary Outcome Measures

Objective response [Time Frame: Up to 1 year] [Designated as safety issue: ]


Secondary Outcome Measures

Incidence of adverse events [Time Frame: Up to 1 year] [Designated as safety issue: ]

Pharmacokinetics (PK) parameters of cabozantinib s-malate [Time Frame: Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1, and prior to dose and 2-4 hours after dose on day 22 of cycle 1, prior to dose on day 1 of cycles 2 and 3] [Designated as safety issue: ]

Estimated Enrollment: 146
Study Start Date: May 2017
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2021
Arms Assigned Interventions

Experimental:Treatment (cabozantinib s-malate)

Patients receive cabozantinib-s-malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other:Pharmacological Study
Correlative studies

Eligibility

Ages Eligible for Study: 30 Years-30 Years

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Upper age limit of =< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC)
  • Patients must have a body surface area >= 0.35 m^2
  • Patients must have recurrent or refractory disease, or newly diagnosed disease with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life; patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse:
  • Ewing sarcoma
  • Rhabdomyosarcoma (RMS)
  • Non-rhabdomyosarcoma soft tissue sarcomas (STS) including microphthalmia transcription factor associated STS (alveolar soft part sarcoma [ASPS] and clear cell sarcoma [CCS])
  • Osteosarcoma
  • Wilms tumor
  • Rare tumors
  • Medullary thyroid carcinoma (MTC)
  • Renal cell carcinoma (RCC)
  • Hepatocellular carcinoma (HCC)
  • Hepatoblastoma
  • Adrenocortical carcinoma
  • Pediatric solid tumors (including central nervous system [CNS] tumors) with known molecular alterations in the targets of XL184 (i.e., MET amplification, overexpression, activating mutation, MET translocation, MET exon skipping mutations, activating RET mutations, RET rearrangement, overexpression or activation of AXL); documentation of the alteration from a Clinical Laboratory Improvement Act (CLIA) certified laboratory will be required
  • Note: Documentation of any known tumor molecular alterations and RET mutation status for patients with MTC (germline) must be uploaded via the RAVE system
  • Patients must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm)
  • Note: The following do NOT qualify as measurable disease:
  • Malignant fluid collections (e.g., ascites, pleural effusions)
  • Bone marrow infiltration
  • Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans)
  • Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
  • Previously radiated lesions that have not demonstrated clear progression post radiation
  • Leptomeningeal lesions that do not meet the measurement parameters noted above
  • Patients must have a Lansky or Karnofsky performance status score of >= 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
  • Patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
  • At least 7 days must have elapsed since the completion of therapy with a growth factor. At least 14 days must have elapsed after receiving pegfilgrastim
  • Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent
  • Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
  • >= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of M-Iodobenzylguanidine (MIBG); >= 3 months must have elapsed if prior craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total-body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given
  • Subjects should not have any clinically relevant ongoing complications from prior radiation therapy (i.e., radiation esophagitis or other inflammation of the viscera)
  • No evidence of active graft versus (vs.) host disease and >= 2 months must have elapsed since transplant
  • Not previously received XL184 or another MET/HGF inhibitor (tivantinib or crizotinib); there are no limits on number of prior therapeutic regimens; patients who have been treated with prior VEGF pathway, or RET inhibitors (except XL184) may be eligible
  • Peripheral absolute neutrophil count (ANC) >= 1000/uL for patients with solid tumors without bone marrow involvement
  • Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment) for patients with solid tumors without bone marrow involvement
  • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) for patients with solid tumors without bone marrow involvement
  • Peripheral absolute neutrophil count (ANC) >= 750/uL for patients with solid tumors and known bone marrow metastatic disease
  • Platelet count >= 50,000/uL for patients with solid tumors and known bone marrow metastatic disease
  • Hemoglobin >= 8.0 g/dL for patients with solid tumors and known bone marrow metastatic disease
  • Transfusions are permitted to meet both the platelet and hemoglobin criteria; patients must not be known to be refractory to red blood cell or platelet transfusions
  • 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:
  • 2 to < 6 years of age
  • Male and female: 0.8 (maximum serum creatinine [mg/dL])
  • 6 to < 10 years of age
  • Male and female: 1 (maximum serum creatinine [mg/dL])
  • 10 to < 13 years of age
  • Male and female: 1.2 (maximum serum creatinine [mg/dL])
  • 13 to < 16 years of age
  • Male 1.5 (maximum serum creatinine [mg/dL])
  • Female: 1.4 (maximum serum creatinine [mg/dL])
  • >= 16 years of age
  • Male: 1.7 (maximum serum creatinine [mg/dL])
  • Female: 1.4 (maximum serum creatinine [mg/dL])
  • Urine protein: =< 30 mg/dl in urinalysis or =< 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hour (h) urine sample
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (3 x ULN) (for the purpose of this study, the ULN for SGPT is 45 U/L)
  • Serum albumin >= 2.8 g/dL
  • No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
  • No clinically significant cardiac arrhythmias, stroke or myocardial infarction within 6 months prior to enrollment
  • QTc =< 480 msec; Note: Patients with grade 1 prolonged QTc (450- 480 msec) at the time of study enrollment should have correctable causes of prolonged QTc addressed if possible (i.e., electrolytes, medications)
  • Patients with a known seizure disorder who are receiving non-enzyme inducing anticonvulsants and have well-controlled seizures may be enrolled
  • CNS toxicity =< grade 2 with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible
  • A blood pressure (BP) =< the 95th percentile for age, height, and gender for pediatric patients < 18 years old and =< 140/90 mmHg for patients >= 18 years old; patients should not be receiving medication for treatment of hypertension (except patients with Wilms tumor and RCC who may be eligible if on stable doses of no more than one anti-hypertensive medication with a baseline BP =< ULN for pediatric patients and =< 140/90 for adult patients); please note that 3 serial blood pressures should be obtained and averaged to determine baseline BP
  • International normalized ratio (INR) =< 1.5
  • Serum amylase =< 1.5 ULN
  • Serum lipase =< 1.5 ULN

Exclusion Criteria:

  • Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use two methods of birth control- a medically accepted barrier method of contraceptive method (e.g., male or female condom) and a second effective method of birth control-during protocol therapy and for at least 4 months after the last dose of XL184; abstinence is an acceptable method of birth control
  • Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment (14 days if pegfilgrastim)
  • Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
  • Previous treatment with XL184 (cabozantinib) or another MET/HGF inhibitor (tivantinib, crizotinib)
  • Patients who are currently receiving another investigational drug are not eligible
  • Patients who are currently receiving other anti-cancer agents are not eligible
  • Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial
  • Patients must not be receiving any of the following potent CYP3A4 inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John's wort
  • Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin, and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) are prohibited
  • Note: Low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen
  • Patients must not have received enzyme-inducing anticonvulsants within 14 days prior to enrollment
  • Patients who are receiving drugs that prolong QTc are not eligible
  • Patients who are unable to swallow intact tablets are not eligible
  • Patients who have an uncontrolled infection are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
  • Patients with active bleeding are not eligible; specifically, no clinically significant gastrointestinal (GI) bleeding, GI perforation, intra-abdominal abscess or fistula for 6 months prior to enrollment, no hemoptysis or other signs of pulmonary hemorrhage for 3 months prior to enrollment; patients with evidence of an acute intracranial or intratumoral hemorrhage on CT or MRI are not eligible (patients with evidence of resolving hemorrhage will be eligible); in patients with CNS tumors, an MRI with ECHO gradient sequences would be required to exclude presence of petechial hemorrhages
  • Patients who have had or are planning to have the following invasive procedures are not eligible:
  • Major surgical procedure, laparoscopic procedure, or open biopsy within 28 days prior to enrollment
  • Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines (e.g., Hickman or Broviac catheter, peripherally inserted central catheter [PICC]) and at least 7 days prior to enrollment for a subcutaneous port
  • Core biopsy within 7 days prior to enrollment
  • Fine needle aspirate within 7 days prior to enrollment
  • Surgical or other wounds must be adequately healed prior to enrollment
  • NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy
  • Patients who have had significant traumatic injury within 28 days prior to enrollment are not eligible
  • Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of the study drug are not eligible

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02867592

Locations

  • United States, Alabama
    • Children's Hospital of Alabama Birmingham, Alabama, United States, 35233
  • United States, Alaska
    • Providence Alaska Medical Center Anchorage, Alaska, United States, 99508
  • United States, Arkansas
    • Arkansas Children's Hospital Little Rock, Arkansas, United States, 72202-3591
  • United States, California
    • Kaiser Permanente-Anaheim Anaheim, California, United States, 92806
    • Kaiser Permanente-Bellflower Bellflower, California, United States, 90706
    • Kaiser Permanente Downey Medical Center Downey, California, United States, 90242
    • Kaiser Permanente-Fontana Fontana, California, United States, 92335
    • Loma Linda University Medical Center Loma Linda, California, United States, 92354
    • Children's Hospital Los Angeles Los Angeles, California, United States, 90027
    • Kaiser Permanente Los Angeles Medical Center Los Angeles, California, United States, 90027
    • Valley Children's Hospital Madera, California, United States, 93636
    • Children's Hospital and Research Center at Oakland Oakland, California, United States, 94609-1809
    • Children's Hospital of Orange County Orange, California, United States, 92868
    • Lucile Packard Children's Hospital Stanford University Palo Alto, California, United States, 94304
    • University of California Davis Comprehensive Cancer Center Sacramento, California, United States, 95817
    • Kaiser Permanente-San Diego Mission San Diego, California, United States, 92108
    • Rady Children's Hospital - San Diego San Diego, California, United States, 92123
    • UCSF Medical Center-Mission Bay San Francisco, California, United States, 94158
  • United States, Colorado
    • Children's Hospital Colorado Aurora, Colorado, United States, 80045
    • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado, United States, 80218
  • United States, Connecticut
    • Connecticut Children's Medical Center Hartford, Connecticut, United States, 06106
    • Yale University New Haven, Connecticut, United States, 06520
  • United States, Delaware
    • Alfred I duPont Hospital for Children Wilmington, Delaware, United States, 19803
  • United States, District of Columbia
    • Kaiser Permanente-Capitol Hill Medical Center Washington, District of Columbia, United States, 20002
    • Children's National Medical Center Washington, District of Columbia, United States, 20010
  • United States, Florida
    • Golisano Children's Hospital of Southwest Florida Fort Myers, Florida, United States, 33908
    • University of Florida Health Science Center - Gainesville Gainesville, Florida, United States, 32610
    • Nemours Children's Clinic-Jacksonville Jacksonville, Florida, United States, 32207
    • University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida, United States, 33136
    • Nicklaus Children's Hospital Miami, Florida, United States, 33155
    • AdventHealth Orlando Orlando, Florida, United States, 32803
    • Arnold Palmer Hospital for Children Orlando, Florida, United States, 32806
    • Nemours Children's Hospital Orlando, Florida, United States, 32827
    • Nemours Children's Clinic - Pensacola Pensacola, Florida, United States, 32504
    • Johns Hopkins All Children's Hospital Saint Petersburg, Florida, United States, 33701
  • United States, Georgia
    • Children's Healthcare of Atlanta - Egleston Atlanta, Georgia, United States, 30322
  • United States, Hawaii
    • Straub Clinic and Hospital Honolulu, Hawaii, United States, 96813
    • Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii, United States, 96819
    • Kapiolani Medical Center for Women and Children Honolulu, Hawaii, United States, 96826
  • United States, Idaho
    • Saint Luke's Mountain States Tumor Institute Boise, Idaho, United States, 83712
  • United States, Illinois
    • Lurie Children's Hospital-Chicago Chicago, Illinois, United States, 60611
    • University of Illinois Chicago, Illinois, United States, 60612
    • University of Chicago Comprehensive Cancer Center Chicago, Illinois, United States, 60637
    • Carle on Vermilion Danville, Illinois, United States, 61832
    • Carle Physician Group-Effingham Effingham, Illinois, United States, 62401
    • Carle Physician Group-Mattoon/Charleston Mattoon, Illinois, United States, 61938
    • Saint Jude Midwest Affiliate Peoria, Illinois, United States, 61637
    • Carle Cancer Center Urbana, Illinois, United States, 61801
    • The Carle Foundation Hospital Urbana, Illinois, United States, 61801
  • United States, Indiana
    • Riley Hospital for Children Indianapolis, Indiana, United States, 46202
    • Saint Vincent Hospital and Health Care Center Indianapolis, Indiana, United States, 46260
  • United States, Iowa
    • Blank Children's Hospital Des Moines, Iowa, United States, 50309
    • Iowa Methodist Medical Center Des Moines, Iowa, United States, 50309
    • Iowa Lutheran Hospital Des Moines, Iowa, United States, 50316
    • University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa, United States, 52242
  • United States, Kentucky
    • University of Kentucky/Markey Cancer Center Lexington, Kentucky, United States, 40536
    • Norton Children's Hospital Louisville, Kentucky, United States, 40202
  • United States, Louisiana
    • Children's Hospital New Orleans New Orleans, Louisiana, United States, 70118
  • United States, Maine
    • Eastern Maine Medical Center Bangor, Maine, United States, 04401
    • Lafayette Family Cancer Center-EMMC Brewer, Maine, United States, 04412
  • United States, Maryland
    • Sinai Hospital of Baltimore Baltimore, Maryland, United States, 21215
    • Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland, United States, 21287
    • National Institutes of Health Clinical Center Bethesda, Maryland, United States, 20892
  • United States, Massachusetts
    • Massachusetts General Hospital Cancer Center Boston, Massachusetts, United States, 02114
    • Dana-Farber Cancer Institute Boston, Massachusetts, United States, 02215
  • United States, Michigan
    • C S Mott Children's Hospital Ann Arbor, Michigan, United States, 48109
    • Wayne State University/Karmanos Cancer Institute Detroit, Michigan, United States, 48201
    • Ascension Saint John Hospital Detroit, Michigan, United States, 48236
    • Huron Medical Center PC Port Huron, Michigan, United States, 48060
    • Beaumont Children's Hospital-Royal Oak Royal Oak, Michigan, United States, 48073
  • United States, Minnesota
    • Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota, United States, 55404
    • University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota, United States, 55455
    • Mayo Clinic Rochester, Minnesota, United States, 55905
  • United States, Mississippi
    • University of Mississippi Medical Center Jackson, Mississippi, United States, 39216
  • United States, Missouri
    • Siteman Cancer Center at West County Hospital Creve Coeur, Missouri, United States, 63141
    • Children's Mercy Hospitals and Clinics Kansas City, Missouri, United States, 64108
    • Cardinal Glennon Children's Medical Center Saint Louis, Missouri, United States, 63104
    • Barnes-Jewish Hospital Saint Louis, Missouri, United States, 63110
    • Washington University School of Medicine Saint Louis, Missouri, United States, 63110
    • Siteman Cancer Center-South County Saint Louis, Missouri, United States, 63129
    • Mercy Hospital Saint Louis Saint Louis, Missouri, United States, 63141
    • Siteman Cancer Center at Saint Peters Hospital Saint Peters, Missouri, United States, 63376
  • United States, Nebraska
    • Children's Hospital and Medical Center of Omaha Omaha, Nebraska, United States, 68114
    • University of Nebraska Medical Center Omaha, Nebraska, United States, 68198
  • United States, Nevada
    • Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada, United States, 89052
    • Sunrise Hospital and Medical Center Las Vegas, Nevada, United States, 89109
    • Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada, United States, 89135
    • Summerlin Hospital Medical Center Las Vegas, Nevada, United States, 89144
    • Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada, United States, 89048
    • Radiation Oncology Associates Reno, Nevada, United States, 89509
  • United States, New Hampshire
    • Dartmouth Hitchcock Medical Center Lebanon, New Hampshire, United States, 03756
  • United States, New Jersey
    • Hackensack University Medical Center Hackensack, New Jersey, United States, 07601
    • Morristown Medical Center Morristown, New Jersey, United States, 07960
    • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey, United States, 08903
  • United States, New York
    • Roswell Park Cancer Institute Buffalo, New York, United States, 14263
    • NYU Winthrop Hospital Mineola, New York, United States, 11501
    • The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York, United States, 11040
    • Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York, United States, 10016
    • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York, United States, 10032
    • State University of New York Upstate Medical University Syracuse, New York, United States, 13210
  • United States, North Carolina
    • UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina, United States, 27599
    • Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina, United States, 28203
    • Southeastern Medical Oncology Center-Clinton Clinton, North Carolina, United States, 28328
    • Duke University Medical Center Durham, North Carolina, United States, 27710
    • Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina, United States, 27534
    • Wayne Memorial Hospital Goldsboro, North Carolina, United States, 27534
    • East Carolina University Greenville, North Carolina, United States, 27834
    • Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina, United States, 28546
  • United States, Ohio
    • Cincinnati Children's Hospital Medical Center Cincinnati, Ohio, United States, 45229
    • Rainbow Babies and Childrens Hospital Cleveland, Ohio, United States, 44106
    • MetroHealth Medical Center Cleveland, Ohio, United States, 44109
    • Cleveland Clinic Foundation Cleveland, Ohio, United States, 44195
    • Nationwide Children's Hospital Columbus, Ohio, United States, 43205
    • Dayton Children's Hospital Dayton, Ohio, United States, 45404
    • ProMedica Flower Hospital Sylvania, Ohio, United States, 43560
    • The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio, United States, 43606
  • United States, Oklahoma
    • University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma, United States, 73104
  • United States, Oregon
    • Oregon Health and Science University Portland, Oregon, United States, 97239
  • United States, Pennsylvania
    • Children's Hospital of Philadelphia Philadelphia, Pennsylvania, United States, 19104
    • Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania, United States, 15224
  • United States, South Carolina
    • Medical University of South Carolina Charleston, South Carolina, United States, 29425
    • Saint Francis Hospital Greenville, South Carolina, United States, 29601
    • BI-LO Charities Children's Cancer Center Greenville, South Carolina, United States, 29605
    • Saint Francis Cancer Center Greenville, South Carolina, United States, 29607
  • United States, Tennessee
    • East Tennessee Childrens Hospital Knoxville, Tennessee, United States, 37916
    • St. Jude Children's Research Hospital Memphis, Tennessee, United States, 38105
    • The Children's Hospital at TriStar Centennial Nashville, Tennessee, United States, 37203
  • United States, Texas
    • Medical City Dallas Hospital Dallas, Texas, United States, 75230
    • UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas, United States, 75390
    • El Paso Children's Hospital El Paso, Texas, United States, 79905
    • Texas Tech University Health Sciences Center-El Paso El Paso, Texas, United States, 79905
    • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas, United States, 77030
  • United States, Vermont
    • University of Vermont and State Agricultural College Burlington, Vermont, United States, 05405
  • United States, Virginia
    • University of Virginia Cancer Center Charlottesville, Virginia, United States, 22908
    • Children's Hospital of The King's Daughters Norfolk, Virginia, United States, 23507
  • United States, Washington
    • Seattle Children's Hospital Seattle, Washington, United States, 98105
    • Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington, United States, 99204
  • United States, Wisconsin
    • Gundersen Lutheran Medical Center La Crosse, Wisconsin, United States, 54601
    • University of Wisconsin Hospital and Clinics Madison, Wisconsin, United States, 53792
    • Children's Hospital of Wisconsin Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02867592
Other Study ID Numbers: NCI-2016-01258
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Carcinoma

Neoplasms

Sarcoma

Carcinoma, Hepatocellular

Thyroid Diseases

Carcinoma, Renal Cell

Osteosarcoma

Rhabdomyosarcoma

Sarcoma, Ewing

Wilms Tumor

Nervous System Neoplasms

Central Nervous System Neoplasms

Sarcoma, Alveolar Soft Part

Hepatoblastoma

Carcinoma, Medullary

Thyroid Neoplasms

Carcinoma, Neuroendocrine

Sarcoma, Clear Cell

Adrenocortical Carcinoma

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019