A Phase 2 interventional study of Cixutumumab and Laboratory Biomarker Analysis in Childhood Alveolar Soft Part Sarcoma, Childhood Angiosarcoma and Childhood Epithelioid Sarcoma, sponsored by National Cancer Institute (NCI). Completed at 76 sites in 2 countries. Open to participants aged 1 Year to 30 Years. Per ClinicalTrials.gov, last updated 2018-12-11.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
This phase II trial studies how well cixutumumab and temsirolimus work in treating patients with recurrent or refractory sarcoma. 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. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab and temsirolimus together may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the objective response rate to the combination of cixutumumab and temsirolimus in patients with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or non-rhabdomyosarcoma soft tissue sarcoma.
II. To further describe the toxicities (including dose-limiting toxicities) of cixutumumab and temsirolimus administered on this schedule.
SECONDARY OBJECTIVES:
I. To assess the progression-free survival for patients treated in each disease stratum with this drug combination.
II. To assess the incidence of insulin-like growth factor 1 receptor (IGF-1R), insulin receptor, ERK, RON, and mammalian target of rapamycin (mTOR) pathway activation in archival tumor material, and correlate with response.
III. To evaluate minimal residual disease and IGF-1R tumor cell expression in the blood and bone marrow of Ewing sarcoma patients using flow cytometry.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (osteosarcoma vs Ewing sarcoma/PNET vs rhabdomyosarcoma vs non-rhabdomyosarcoma soft tissue sarcoma).
Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
Archived tumor tissue samples from most recent biopsy are collected and analyzed for IGF-1R, insulin receptor, AKT, ERK, mTOR, and S6 kinase pathway activation by immunohistochemistry (IHC) and banked for future correlative studies. Blood and bone marrow samples, from patients with Ewing sarcoma, may be collected at baseline and periodically during treatment for minimal residual disease analysis by flow cytometry.
After completion of study treatment, patients are followed up periodically for 5 years.
99 studies on the registry are indexed under Hemangiosarcoma; 16 are open to participants now.
This study's enrollment of 46 is below the median of 64 across 83 interventional studies indexed under Hemangiosarcoma.
Browse Hemangiosarcoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients with any of the following tumors who have experienced relapse following front-line therapy, or who are to front-line therapy, are eligible:
All patients are required to submit for immunohistochemical analysis (either paraffin-embedded tumor blocks or unstained slides)
Patients must have radiographically
The following do not qualify as measurable disease:
Patients must have a Lansky or performance status score of ? 50%, corresponding to (ECOG) categories 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients ? 16 years of age
For patients with solid tumors without bone marrow involvement:
For patients with solid tumors and known bone marrow metastatic disease:
Hemoglobin ? 8.0 g/dL (may receive RBC transfusions)
or radioisotope ? 70 mL/min OR a serum creatinine based on age/gender as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
Biological: Cixutumumab · Other: Laboratory Biomarker Analysis · Drug: Temsirolimus
Given IV
Also known as: Anti-IGF-1R Recombinant Monoclonal Antibody IMC-A12, IMC-A12
Correlative studies
Given IV
Also known as: CCI-779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, Rapamycin Analog, Rapamycin Analog CCI-779, Torisel
Objective Response Rate (PR or CR) by Response Evaluation Criteria in Solid Tumors (RECIST).
Per Response evaluation criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR)= CR+PR. The combination of sufficient activity is considered if the true response rate is 35% or greater.
Time frame: 6 cycles (168 days)
Number of Cycles of Toxicity
The number of patients-cycles where CTC Version 4 grade 3 or higher increased Alanine aminotransferase was observed
Time frame: Duration of protocol therapy - Up to 25 cycles (700 days)
Progression-free Interval
Percentage Probability of remaining progression-free 5 years after enrollment estimated by the method of Kaplan and Meier
Time frame: 10 months after enrollment
Expression Levels of IGF-1R, Insulin Receptor, ERK, RON, and mTOR
Number of patients expressing insulin-like growth factor 1 receptor (IGF-1R), insulin receptor, ERK, RON, and mammalian target of rapamycin (mTOR) at levels 0, 1+, 2+, 3+ by immunohistochemistry.
Time frame: Baseline
Number of Patients With Detectable Bone Marrow Micrometastatic Disease Estimated as the Proportion of Eligible Patients Entered Into the Ewing Sarcoma Stratum Who Have Detectable Tumor Cells in the Marrow at Enrollment
Time frame: Baseline
| Milestone | Group 1 Relapsed or Refractory Osteosarcoma | Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Group 3 Relapsed or Refractory Rhabdomyosarcoma | Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma |
|---|---|---|---|---|
| Started | 11 | 12 | 11 | 12 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 11 | 12 | 11 | 12 |
| Withdrew: Adverse event | 0 | 0 | 1 | 1 |
| Withdrew: Lack of efficacy | 10 | 10 | 9 | 8 |
| Withdrew: Physician decision | 1 | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 2 |
| Withdrew: Ineligible | 0 | 1 | 0 | 0 |
Per Response evaluation criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR)= CR+PR. The combination of sufficient activity is considered if the true response rate is 35% or greater.
| participants | Group 1 Relapsed or Refractory Osteosarcoma | Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Group 3 Relapsed or Refractory Rhabdomyosarcoma | Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma |
|---|---|---|---|---|
| Non-Responder | 10 | 11 | 11 | 11 |
| Responder | 0 | 0 | 0 | 0 |
The number of patients-cycles where CTC Version 4 grade 3 or higher increased Alanine aminotransferase was observed
| cycles | Treatment (Cixutumumab, Temsirolimus) |
|---|---|
| Alkaline phosphatase | 1 |
| Anaphylaxis | 1 |
| Anemia | 3 |
| Ascites | 1 |
| Aspartate aminotransferase | 3 |
| Decreased lymphocyte count | 1 |
| Decreased platelet count | 5 |
| Decreased white blood cells | 3 |
| Duodenal obstruction | 1 |
| Epistaxis | 1 |
| Extremity pain | 1 |
| Hyperglycemia | 1 |
| Hypermagnesemia | 1 |
| Hypertriglyceridemia | 2 |
| Hyperuricemia | 1 |
| Hypoalbuminemia | 1 |
| Hypokalemia | 5 |
| Hyponatremia | 1 |
| Hypophosphatemia | 4 |
| Hypoxia | 1 |
| Increased alanine aminotransferase | 2 |
| Increased blood bilirubin | 1 |
| Increased creatinine | 1 |
| Multi-organ failure | 1 |
| Neutopenia | 6 |
| Non-cardiac chest pain | 1 |
| Other cardiac disorders | 1 |
| Other infections and infestations | 1 |
| Oral mucocitis | 4 |
| Pain | 2 |
| Paronychia | 1 |
| Urinary tract infection | 1 |
| Urinary tract obstruction | 1 |
| Weight loss | 1 |
| Wound infection | 1 |
Percentage Probability of remaining progression-free 5 years after enrollment estimated by the method of Kaplan and Meier
| percent probability | Group 1 Relapsed or Refractory Osteosarcoma | Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Group 3 Relapsed or Refractory Rhabdomyosarcoma | Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma |
|---|---|---|---|---|
| Progression-free Interval | 9.09 (0.54 to 33.29) | 9.09 (0.54 to 33.29) | 9.09 (0.54 to 33.29) | 16.67 (2.65 to 41.30) |
Number of patients expressing insulin-like growth factor 1 receptor (IGF-1R), insulin receptor, ERK, RON, and mammalian target of rapamycin (mTOR) at levels 0, 1+, 2+, 3+ by immunohistochemistry.
| Participants | Group 1 Relapsed or Refractory Osteosarcoma | Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Group 3 Relapsed or Refractory Rhabdomyosarcoma | Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma |
|---|---|---|---|---|
| IGF-1R level 0 | 2 | 4 | 1 | 3 |
| IGF-1R level 1+ | 4 | 3 | 0 | 4 |
| IGF-1R level 2+ | 2 | 2 | 2 | 5 |
| IGF-1R level 3+ | 2 | 2 | 8 | 1 |
| Insulin receptor level 0 | 4 | 4 | 4 | 3 |
| Insulin receptor level 1+ | 2 | 2 | 1 | 2 |
| Insulin receptor level 2+ | 2 | 3 | 4 | 2 |
| Insulin receptor level 3+ | 1 | 2 | 2 | 2 |
| ERK level 0 | 2 | 5 | 6 | 3 |
| ERK level 1+ | 5 | 5 | 2 | 4 |
| ERK level 2+ | 1 | 0 | 3 | 3 |
| ERK Level 3+ | 2 | 1 | 0 | 1 |
| RON level 0 | 7 | 10 | 10 | 6 |
| RON level 1+ | 3 | 1 | 1 | 4 |
| RON level 2+ | 0 | 0 | 0 | 0 |
| RON level 3+ | 0 | 0 | 0 | 1 |
| mTOR level 0 | 8 | 7 | 10 | 8 |
| mTOR level 1+ | 2 | 3 | 1 | 3 |
| mTOR level 2+ | 0 | 1 | 0 | 0 |
| mTOR level 3+ | 0 | 0 | 0 | 0 |
| Participants | Treatment (Cixutumumab, Temsirolimus) |
|---|---|
| Number of Patients With Detectable Bone Marrow Micrometastatic Disease Estimated as the Proportion of Eligible Patients Entered Into the Ewing Sarcoma Stratum Who Have Detectable Tumor Cells in the Marrow at Enrollment | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 Relapsed or Refractory Osteosarcoma | — | 2/11 (18.2%) | 11/11 (100%) |
| Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | — | 3/11 (27.3%) | 5/11 (45.5%) |
| Group 3 Relapsed or Refractory Rhabdomyosarcoma | — | 2/11 (18.2%) | 7/11 (63.6%) |
| Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma | — | 7/12 (58.3%) | 6/12 (50%) |
| Event | Group 1 Relapsed or Refractory Osteosarcoma | Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Group 3 Relapsed or Refractory Rhabdomyosarcoma | Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma |
|---|---|---|---|---|
| Alanine aminotransferase increasedInvestigations | 0/11 | 0/11 | 2/11 | 0/12 |
| Aspartate aminotransferase increasedInvestigations | 0/11 | 0/11 | 2/11 | 1/12 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - OtherNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/11 | 1/11 | 0/11 | 0/12 |
| Mucositis oralGastrointestinal disorders | 0/11 | 0/11 | 0/11 | 2/12 |
| Alkaline phosphatase increasedInvestigations | 0/11 | 0/11 | 1/11 | 0/12 |
| AscitesGastrointestinal disorders | 0/11 | 0/11 | 1/11 | 0/12 |
| Blood bilirubin increasedInvestigations | 0/11 | 0/11 | 1/11 | 0/12 |
| Creatinine increasedInvestigations | 0/11 | 0/11 | 1/11 | 0/12 |
| Duodenal obstructionGastrointestinal disorders | 0/11 | 0/11 | 1/11 | 0/12 |
| HypermagnesemiaMetabolism and nutrition disorders | 0/11 | 0/11 | 1/11 | 0/12 |
| Event | Group 1 Relapsed or Refractory Osteosarcoma | Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Group 3 Relapsed or Refractory Rhabdomyosarcoma | Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma |
|---|---|---|---|---|
| Mucositis oralGastrointestinal disorders | 5/11 | 1/11 | 3/11 | 3/12 |
| HypokalemiaMetabolism and nutrition disorders | 3/11 | 0/11 | 0/11 | 1/12 |
| Neutrophil count decreasedInvestigations | 3/11 | 0/11 | 1/11 | 1/12 |
| Platelet count decreasedInvestigations | 0/11 | 2/11 | 3/11 | 0/12 |
| AnemiaBlood and lymphatic system disorders | 2/11 | 0/11 | 2/11 | 0/12 |
| HyponatremiaMetabolism and nutrition disorders | 2/11 | 0/11 | 0/11 | 0/12 |
| HypophosphatemiaMetabolism and nutrition disorders | 2/11 | 0/11 | 0/11 | 1/12 |
| White blood cell decreasedInvestigations | 2/11 | 0/11 | 0/11 | 1/12 |
| ConfusionPsychiatric disorders | 0/11 | 1/11 | 0/11 | 0/12 |
| Creatinine increasedInvestigations | 1/11 | 0/11 | 0/11 | 1/12 |
| Age, Categorical(Participants) | Group 1 Relapsed or Refractory Osteosarcoma | Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Group 3 Relapsed or Refractory Rhabdomyosarcoma | Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma | Total |
|---|---|---|---|---|---|
| <=18 years | 7 | 8 | 9 | 7 | 31 |
| Between 18 and 65 years | 4 | 4 | 2 | 5 | 15 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Group 1 Relapsed or Refractory Osteosarcoma | Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Group 3 Relapsed or Refractory Rhabdomyosarcoma | Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma | Total |
|---|---|---|---|---|---|
| Median | 18 (7 to 25) | 17.5 (9 to 27) | 14 (1 to 23) | 17.5 (13 to 26) | 17 (1 to 27) |
| Sex: Female, Male(Participants) | Group 1 Relapsed or Refractory Osteosarcoma | Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Group 3 Relapsed or Refractory Rhabdomyosarcoma | Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma | Total |
|---|---|---|---|---|---|
| Female | 1 | 6 | 8 | 5 | 20 |
| Male | 10 | 6 | 3 | 7 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 Relapsed or Refractory Osteosarcoma | Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Group 3 Relapsed or Refractory Rhabdomyosarcoma | Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 3 | 0 | 4 |
| Not Hispanic or Latino | 10 | 12 | 8 | 11 | 41 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Group 1 Relapsed or Refractory Osteosarcoma | Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Group 3 Relapsed or Refractory Rhabdomyosarcoma | Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 0 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 0 | 0 | 2 |
| Black or African American | 2 | 0 | 0 | 1 | 3 |
| White | 7 | 8 | 9 | 7 | 31 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 | 2 | 6 |
| Region of Enrollment(participants) | Group 1 Relapsed or Refractory Osteosarcoma | Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Group 3 Relapsed or Refractory Rhabdomyosarcoma | Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma | Total |
|---|---|---|---|---|---|
| United States | 11 | 11 | 11 | 12 | 45 |
| Canada | 0 | 1 | 0 | 0 | 1 |
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cixutumumab
National Cancer Institute (NCI) →