Adrenocortical carcinoma · NCT02867592
Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
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
- Status
- ACTIVE_NOT_RECRUITING (ClinicalTrials.gov)
- Phase
- PHASE2
- Sponsor
- National Cancer Institute (NCI)
- Registry records
- CTGOV NCT02867592 (ACTIVE_NOT_RECRUITING)Registry last updated 2026-08-28
Eligibility, line by line
| Verdict | In plain words (machine summary) | Registry text, verbatim | If unmet |
|---|---|---|---|
| inclusion inclusion · age sex · confidence 0.95 | Upper age limit of =\< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) | "Upper age limit of =\< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC)" | |
| inclusion inclusion · age sex · confidence 0.95 | =\< 30 years for all other diagnoses | "=\< 30 years for all other diagnoses" | |
| inclusion inclusion · other · confidence 0.30 | Patients must have a body surface area \>= 0.35 m\^2 | "Patients must have a body surface area" | |
| inclusion inclusion · stage extent · confidence 0.30 | 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 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" | |
| inclusion inclusion · condition · confidence 0.95 | Histologic verification of one of the listed malignancies at original diagnosis or at relapse (Ewing sarcoma, rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcomas, osteosarcoma, Wilms tumor, MTC, RCC, HCC, hepatoblastoma, adrenal cortex carcinoma, pediatric solid tumors with known molecular alterations) | "patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse" | |
| inclusion inclusion · biomarker · confidence 0.85 | Pediatric solid tumors (including CNS tumors) with known molecular alterations in the targets of XL184 (MET, RET, AXL alterations) | "with known molecular alterations in the targets of XL184" | |
| inclusion inclusion · logistics · confidence 0.30 | Documentation of the alteration from a CLIA certified laboratory will be required | "documentation of the alteration from a Clinical Laboratory Improvement Act (CLIA) certified laboratory will be required" | |
| inclusion inclusion · lesion burden · confidence 0.97 | Patients must have radiographically measurable disease | "Patients must have radiographically measurable disease" | |
| inclusion inclusion · performance status · confidence 0.95 | Lansky or Karnofsky performance status score of \>= 50, corresponding to ECOG categories 0, 1 or 2 | "Patients must have a Lansky or Karnofsky performance status score of \>= 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2" | |
| inclusion inclusion · prior therapy · confidence 0.30 | Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study | "Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study" | |
| inclusion inclusion · washout · confidence 0.90 | Patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea) | "Patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)" | |
| inclusion inclusion · washout · confidence 0.93 | At least 7 days must have elapsed since the completion of therapy with a growth factor | "At least 7 days must have elapsed since the completion of therapy with a growth factor" | |
| inclusion inclusion · washout · confidence 0.93 | At least 14 days must have elapsed after receiving pegfilgrastim | "At least 14 days must have elapsed after receiving pegfilgrastim" | |
| inclusion inclusion · washout · confidence 0.30 | Anti-cancer agents not known to be myelosuppressive: >= 7 days after the last dose of agent | "Anti-cancer agents not known to be myelosuppressive" | |
| inclusion inclusion · washout · confidence 0.93 | Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody | "Antibodies: \>= 21 days must have elapsed from infusion of last dose of antibody" | |
| inclusion inclusion · prior therapy · confidence 0.30 | Toxicity related to prior antibody therapy must be recovered to grade =\< 1 | "toxicity related to prior antibody therapy must be recovered to grade =\< 1" | |
| inclusion inclusion · washout · confidence 0.30 | >= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port) | "2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port)" | |
| inclusion inclusion · washout · confidence 0.30 | >= 6 weeks must have elapsed since treatment with therapeutic doses of MIBG | "6 weeks must have elapsed since treatment with therapeutic doses of M-Iodobenzylguanidine (MIBG)" | |
| inclusion inclusion · washout · confidence 0.30 | >= 3 months must have elapsed if prior craniospinal XRT, >= 50% of pelvis irradiated, or TBI received | "3 months must have elapsed if prior craniospinal XRT was received" | |
| inclusion inclusion · washout · confidence 0.30 | >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given | "6 weeks must have elapsed if other substantial bone marrow irradiation was given" | |
| inclusion inclusion · comorbidity · confidence 0.30 | Subjects should not have any clinically relevant ongoing complications from prior radiation therapy | "Subjects should not have any clinically relevant ongoing complications from prior radiation therapy" | |
| inclusion inclusion · comorbidity · confidence 0.93 | No evidence of active graft versus host disease | "No evidence of active graft versus (vs.) host disease" | |
| inclusion inclusion · washout · confidence 0.30 | >= 2 months must have elapsed since transplant | "2 months must have elapsed since transplant" | |
| inclusion inclusion · prior therapy · confidence 0.95 | Not previously received XL184 or another MET/HGF inhibitor (tivantinib or crizotinib) | "Not previously received XL184 or another MET/HGF inhibitor (tivantinib or crizotinib)" | |
| inclusion inclusion · lab value · confidence 0.95 | Peripheral ANC >= 1000/uL for patients with solid tumors without bone marrow involvement | "Peripheral absolute neutrophil count (ANC) \>= 1000/uL for patients with solid tumors without bone marrow involvement" | |
| inclusion inclusion · lab value · confidence 0.95 | Platelet count >= 100,000/uL (transfusion independent) for patients without bone marrow involvement | "Platelet count \>= 100,000/uL" | |
| inclusion inclusion · lab value · confidence 0.95 | Hemoglobin >= 8.0 g/dL (may receive RBC transfusions) for patients without bone marrow involvement | "Hemoglobin \>= 8.0 g/dL (may receive red blood cell" | |
| inclusion inclusion · lab value · confidence 0.95 | Peripheral ANC >= 750/uL for patients with solid tumors and known bone marrow metastatic disease | "Peripheral absolute neutrophil count (ANC) \>= 750/uL for patients with solid tumors and known bone marrow metastatic disease" | |
| inclusion inclusion · lab value · confidence 0.95 | Platelet count >= 50,000/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" | |
| inclusion inclusion · lab value · confidence 0.95 | Hemoglobin >= 8.0 g/dL 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" | |
| inclusion inclusion · comorbidity · confidence 0.30 | Patients must not be known to be refractory to red blood cell or platelet transfusions | "patients must not be known to be refractory to red blood cell or platelet transfusions" | |
| inclusion inclusion · organ function · confidence 0.95 | Creatinine clearance or radioisotope GFR >= 70 mL/min/1.73 m^2 | "Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2" | |
| inclusion inclusion · organ function · confidence 0.30 | Or a serum creatinine based on age/gender below maximum values | "or a serum creatinine based on age/gender as follows" | |
| inclusion inclusion · lab value · confidence 0.90 | Urine protein: =\< 30 mg/dl in urinalysis or =\< 1+ on dipstick, unless quantitative protein is \< 1000 mg in a 24 hour urine sample | "Urine protein: =\< 30 mg/dl in urinalysis or =\< 1+ on dipstick" | |
| inclusion inclusion · lab value · confidence 0.95 | Total bilirubin =\< 1.5 x ULN for age | "Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age" | |
| inclusion inclusion · lab value · confidence 0.95 | SGPT (ALT) =\< 135 U/L (3 x ULN) | "Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (3 x ULN)" | |
| inclusion inclusion · lab value · confidence 0.95 | Serum albumin >= 2.8 g/dL | "Serum albumin \>= 2.8 g/dL" | |
| inclusion inclusion · comorbidity · confidence 0.93 | No history of congenital prolonged corrected QT (QTc) syndrome | "No history of congenital prolonged corrected QT (QTc) syndrome" | |
| inclusion inclusion · comorbidity · confidence 0.93 | No NYHA class III or IV congestive heart failure | "New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)" | |
| inclusion inclusion · comorbidity · confidence 0.95 | No clinically significant cardiac arrhythmias, stroke or myocardial infarction within 6 months prior to enrollment | "No clinically significant cardiac arrhythmias, stroke or myocardial infarction within 6 months prior to enrollment" | |
| inclusion inclusion · organ function · confidence 0.95 | QTc =\< 480 msec | "QTc =\< 480 msec" | |
| inclusion inclusion · comorbidity · confidence 0.30 | Patients with a known seizure disorder who are receiving non-enzyme inducing anticonvulsants and have well-controlled seizures may be enrolled | "Patients with a known seizure disorder who are receiving non-enzyme inducing anticonvulsants and have well-controlled seizures may be enrolled" | |
| inclusion inclusion · organ function · confidence 0.30 | CNS toxicity =\< grade 2 with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible | "CNS toxicity =\< grade 2 with the exception of decreased tendon reflex (DTR)" | |
| inclusion inclusion · organ function · confidence 0.30 | Blood pressure =\< 95th percentile for age, height, gender for patients < 18 years and =\< 140/90 mmHg for patients >= 18 years | "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" | |
| inclusion inclusion · comorbidity · confidence 0.30 | Patients should not be receiving medication for treatment of hypertension (except Wilms tumor and RCC patients on stable dose of no more than one anti-hypertensive) | "patients should not be receiving medication for treatment of hypertension" | |
| inclusion inclusion · lab value · confidence 0.95 | INR =\< 1.5 | "International normalized ratio (INR) =\< 1.5" | |
| inclusion inclusion · lab value · confidence 0.95 | Serum amylase =\< 1.5 x ULN | "Serum amylase =\< 1.5 x ULN" | |
| inclusion inclusion · lab value · confidence 0.95 | Serum lipase =\< 1.5 x ULN | "Serum lipase =\< 1.5 x ULN" | |
| exclusion exclusion · pregnancy contraception · confidence 0.97 | Pregnant or breast-feeding women will not be entered on this study | "Pregnant or breast-feeding women will not be entered on this study" | |
| exclusion exclusion · pregnancy contraception · confidence 0.30 | Males or females of reproductive potential may not participate unless they have agreed to use two methods of birth control | "males or females of reproductive potential may not participate unless they have agreed to use two methods of birth control" | |
| exclusion exclusion · washout · confidence 0.93 | 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) | "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)" | |
| exclusion exclusion · washout · confidence 0.30 | 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 | "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" | |
| exclusion exclusion · washout · confidence 0.30 | If corticosteroids used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose | "if used to modify immune adverse events related to prior therapy, \>= 14 days must have elapsed since last dose of corticosteroid" | |
| exclusion exclusion · prior therapy · confidence 0.97 | Previous treatment with XL184 (cabozantinib) or another MET/HGF inhibitor (tivantinib, crizotinib) | "Previous treatment with XL184 (cabozantinib) or another MET/HGF inhibitor (tivantinib, crizotinib)" | |
| exclusion exclusion · prior therapy · confidence 0.95 | Patients who are currently receiving another investigational drug are not eligible | "Patients who are currently receiving another investigational drug are not eligible" | |
| exclusion exclusion · prior therapy · confidence 0.95 | Patients who are currently receiving other anti-cancer agents are not eligible | "Patients who are currently receiving other anti-cancer agents are not eligible" | |
| exclusion exclusion · prior therapy · confidence 0.95 | Patients receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease or organ rejection 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" | |
| exclusion exclusion · prior therapy · confidence 0.95 | Patients must not be receiving potent CYP3A4 inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John's wort | "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" | |
| exclusion exclusion · prior therapy · confidence 0.92 | Concomitant anticoagulation with oral anticoagulants or platelet inhibitors are prohibited | "Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin, and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) are prohibited" | |
| exclusion exclusion · washout · confidence 0.95 | Patients must not have received enzyme-inducing anticonvulsants within 14 days prior to enrollment | "Patients must not have received enzyme-inducing anticonvulsants within 14 days prior to enrollment" | |
| exclusion exclusion · prior therapy · confidence 0.93 | Patients who are receiving drugs that prolong QTc are not eligible | "Patients who are receiving drugs that prolong QTc are not eligible" | |
| exclusion exclusion · other · confidence 0.30 | Patients who are unable to swallow intact tablets are not eligible | "Patients who are unable to swallow intact tablets are not eligible" | |
| exclusion exclusion · comorbidity · confidence 0.95 | Patients who have an uncontrolled infection are not eligible | "Patients who have an uncontrolled infection are not eligible" | |
| exclusion exclusion · logistics · confidence 0.30 | 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 who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible" | |
| exclusion exclusion · comorbidity · confidence 0.93 | Patients with active bleeding are not eligible; no clinically significant GI bleeding, GI perforation, intra-abdominal abscess or fistula for 6 months, no hemoptysis or pulmonary hemorrhage for 3 months | "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" | |
| exclusion exclusion · comorbidity · confidence 0.93 | Patients with evidence of an acute intracranial or intratumoral hemorrhage on CT or MRI are not eligible | "patients with evidence of an acute intracranial or intratumoral hemorrhage on CT or MRI are not eligible" | |
| exclusion exclusion · washout · confidence 0.30 | Major surgical procedure, laparoscopic procedure, or open biopsy within 28 days prior to enrollment | "Major surgical procedure, laparoscopic procedure, or open biopsy within 28 days prior to enrollment" | |
| exclusion exclusion · washout · confidence 0.30 | Central line or subcutaneous port must be placed at least 3 days (external lines) or 7 days (subcutaneous port) prior to enrollment | "must be placed at least 3 days prior to enrollment for external lines" | |
| exclusion exclusion · washout · confidence 0.30 | Core biopsy within 7 days prior to enrollment | "Core biopsy within 7 days prior to enrollment" | |
| exclusion exclusion · washout · confidence 0.30 | Fine needle aspirate within 7 days prior to enrollment | "Fine needle aspirate within 7 days prior to enrollment" | |
| exclusion exclusion · comorbidity · confidence 0.30 | Surgical or other wounds must be adequately healed prior to enrollment | "Surgical or other wounds must be adequately healed prior to enrollment" | |
| exclusion exclusion · washout · confidence 0.30 | Patients who have had significant traumatic injury within 28 days prior to enrollment are not eligible | "Patients who have had significant traumatic injury within 28 days prior to enrollment are not eligible" | |
| exclusion exclusion · comorbidity · confidence 0.93 | Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of the study drug are not eligible | "Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of the study drug are not eligible" |
Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.
Full eligibility text as the registry publishes it
Inclusion Criteria:
* Upper age limit of =\< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) =\< 30 years for all other diagnoses
* 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
* Adrenal coertex 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 for patients with known bone marrow metastatic disease; 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 x ULN
* Serum lipase =\< 1.5 x 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 eligibleRoutes in: how this trial is reached and paid for
NIH Clinical Center: care at no cost, travel supported
Medical care at the NIH Clinical Center in Bethesda is provided at no cost to people enrolled on a study, and travel and lodging support is available, including for people living outside the US.
For non-US residents NIH provides airfare from the nearest US point of entry and a nightly hotel allowance. That makes Bethesda cheaper to reach than most US hospitals despite the distance. Ask the study contact what the current travel policy covers before booking anything.
Verify with: NIH Clinical Center: participating in a study
Care 0; transatlantic flight at your own cost, then supported
US trials at ordinary hospitals: routine care is billed
In the US a sponsor funds the study drug and study-specific scans, but the routine care around them is billed to insurance. Without US cover that bill falls on you.
Cost is documented as the barrier that stops roughly 45 percent of US patients joining trials, before any question of being a non-resident. Eligibility on paper does not make a US site reachable. One email to the study coordinator asking what a non-resident without US insurance would be billed settles it either way.
Verify with: The study coordinator listed on the registry record
Ask first; potentially very high
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Sites (142)
United States
- Children's Hospital of Alabama, Birmingham
- Providence Alaska Medical Center, Anchorage
- Arkansas Children's Hospital, Little Rock
- Kaiser Permanente-Anaheim, Anaheim
- Kaiser Permanente-Bellflower, Bellflower
- Kaiser Permanente Downey Medical Center, Downey
- Kaiser Permanente-Fontana, Fontana
- Loma Linda University Medical Center, Loma Linda
- Children's Hospital Los Angeles, Los Angeles
- Kaiser Permanente Los Angeles Medical Center, Los Angeles
- Valley Children's Hospital, Madera
- UCSF Benioff Children's Hospital Oakland, Oakland
- and 130 more