| ID | Type | Description | Link |
|---|---|---|---|
| P30CA006516 | U.S. NIH Grant/Contract | View source | |
| CDR0000487628 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Boston Children's Hospital | OTHER |
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RATIONALE: Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide, celecoxib, and fenofibrate may stop the growth of cancer cells by blocking blood flow to the cancer. Celecoxib also may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with thalidomide, celecoxib, and fenofibrate may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving etoposide and cyclophosphamide together with thalidomide, celecoxib, and fenofibrate works in treating young patients with relapsed or progressive cancer.
OBJECTIVES:
Primary
Secondary
STATISTICAL DESIGN: Patients were classified into one of 8 strata according to diagnosis: leukemia/lymphoma, bone tumors, neuroblastoma, high grade glial tumors, low grade glial tumors, ependymoma, medulloblastoma/PNET, and miscellaneous. A two-stage design for each disease stratum was planned. The accrual goal at the end of the two-stage design was 20 subjects for each stratum. A stopping rule was applied after the accrual of the first 10 eligible subjects enrolled in each disease stratum. If 1 or more patients in the first 10 evaluable patients were alive and progression-free at 27 weeks and have tolerated therapy then accrual to stage two would proceed. Among 20 patients within a stratum, if 3 or more patients met primary endpoint then regimen would be considered successful. The probability of concluding the treatment is feasible is 0.95 if true success rate is 30% and 0.07 if true succes rate is 5%. Overall accrual target was 80-160 patients. Please see published manuscript (Robison et al Pediatr Blood Cancer 2014) for results within disease strata.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-drug metronomic antiangiogenic regimen | Experimental | Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| celecoxib | Drug |
| ||
| cyclophosphamide |
| Measure | Description | Time Frame |
|---|---|---|
| Therapy Completion Rate | Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression. | 27 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 27-Week Progression-Free Survival | 27-week progression-free survival is the probability of patients remaining alive and progression-free at 27-weeks from study entry estimated using Kaplan-Meier methods. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression. |
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DISEASE CHARACTERISTICS:
Histologically confirmed cancer (at diagnosis or relapse), including any of the following:
Leukemia and/or lymphoma (closed to accrual)
Bone tumor (e.g., Ewing's sarcoma or osteosarcoma) (closed to accrual)
Neuroblastoma (closed to accrual)
High-grade glial tumor
Low-grade glial tumor
Ependymoma
Medulloblastoma and/or primitive neuroectodermal tumor (PNET)
Miscellaneous tumor (closed to accrual)
Brain stem glioma, defined as intrinsic tumors of the pons causing diffuse enlargement
Brain stem glioma that progressed after radiotherapy does not require histological confirmation
Duration of symptoms at the time of diagnosis must be < 3 months
Relapsed or progressive poor prognosis disease for which no available curative therapy exists
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mark W. Kieran, MD, PhD | Dana-Farber Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States | ||
| Miami Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24123865 | Background | Robison NJ, Campigotto F, Chi SN, Manley PE, Turner CD, Zimmerman MA, Chordas CA, Werger AM, Allen JC, Goldman S, Rubin JB, Isakoff MS, Pan WJ, Khatib ZA, Comito MA, Bendel AE, Pietrantonio JB, Kondrat L, Hubbs SM, Neuberg DS, Kieran MW. A phase II trial of a multi-agent oral antiangiogenic (metronomic) regimen in children with recurrent or progressive cancer. Pediatr Blood Cancer. 2014 Apr;61(4):636-42. doi: 10.1002/pbc.24794. Epub 2013 Oct 4. |
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Patients must have recovered or stabalized the toxicity from prior therapy.
The study was open for patient accrual at 11 different pediatric oncology centers from January 7, 2005 through March 6, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | 5-drug Metronomic Antiangiogenic Regimen | Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| etoposide | Drug |
|
| fenofibrate | Drug |
|
| thalidomide | Drug |
|
| Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks. |
| 27-Week Overall Survival | 27-week overall survival is the probability of patients remaining alive at 27-weeks from study entry estimated using with Kaplan-Meier methods. | Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks. |
| Best Response | As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Best response was regarded as best response at any single assessment. Response was defined as follows: complete resolution of all demonstrable tumor, complete response (CR); >/=50% decrease in the product of the 2 maximum perpendicular diameters relative to the baseline evaluation, partial response (PR); <50% decrease and <25% increase in product of diameters, stable disease (SD); and >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease (PD). For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression. | Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks. |
| Miami |
| Florida |
| 33155-4069 |
| United States |
| Children's Memorial Hospital - Chicago | Chicago | Illinois | 60614 | United States |
| Maine Medical Center Research Institute | Scarborough | Maine | 04074-7205 | United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | United States |
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | United States |
| Began Protocol Therapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis population represents patients who started treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 5-drug Metronmic Antiangiogenic Regimen | Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Disease Group | Patients were stratified within 7 disease strata and an 8th 'miscellaneous' stratum. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Therapy Completion Rate | Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression. | The analysis dataset is comprised of all treated patients. | Number | 90% Confidence Interval | proportion of patients | 27 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | 27-Week Progression-Free Survival | 27-week progression-free survival is the probability of patients remaining alive and progression-free at 27-weeks from study entry estimated using Kaplan-Meier methods. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression. | The analysis dataset is comprised of all treated patients. | Number | 95% Confidence Interval | Probability | Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks. |
| ||||||||||||||||||||||||||||
| Secondary | 27-Week Overall Survival | 27-week overall survival is the probability of patients remaining alive at 27-weeks from study entry estimated using with Kaplan-Meier methods. | The analysis dataset is comprised of all treated patients. | Number | 95% Confidence Interval | Probability | Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks. |
|
| |||||||||||||||||||||||||||
| Secondary | Best Response | As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Best response was regarded as best response at any single assessment. Response was defined as follows: complete resolution of all demonstrable tumor, complete response (CR); >/=50% decrease in the product of the 2 maximum perpendicular diameters relative to the baseline evaluation, partial response (PR); <50% decrease and <25% increase in product of diameters, stable disease (SD); and >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease (PD). For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression. | Number | participants | Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks. |
|
27 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5-drug Metronomic Antiangiogenic Regimen | Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2). | 74 | 97 | 81 | 97 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DE140 | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death - disease progression NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematologic-other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hearing w/w-o audiogr in monitor prg | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis by exam, oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis (symptom) oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdomen, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever w/o neutropenia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity-lower (gait/walking) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ gr3-4 neut, catheter relate | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ gr3-4 neut, lung | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ gr3-4 neut, skin | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut, mucosa | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unk ANC lung | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unk ANC mucosa | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection-other | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Laboratory-other | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity-limb, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myelodysplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy-motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Psychosis | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| (ARDS) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelodysplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cushingnoid appearance | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy CN II vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Keratitis | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular-other | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Distention/bloating, abdominal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis by exam, oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis (symptom) oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anus, hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdomen, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anus, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Oral cavity, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stomach, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever w/o neutropenia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constitutional, other | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity-lower (gait/walking) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Irritability (children <3yrs of age) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest/thoracic pain NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gallbladder, pain | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ gr3-4 neut, upper airway | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut, lip/perioral | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut, mucosa | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut, oral cavity | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut, upper airway | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unk ANC oral cavity/gums | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection Gr 0-2 neut, blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection-other | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Chemoradiation dermatitis | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| PTT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Laboratory-other | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bicarbonate | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity-limb, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy CN V jaw / face-sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy CN XII tongue | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy-motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pyramidal tract dysfunction | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Speech impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neurologic-other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Euphoria | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Personality | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary hemorrhage NOS | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Incontinence urinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/GU-other | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis by exam, pharynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis (symptom) pharynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Kieran | Dana-Farber Cancer Institute | (617) 632-4907 | mark_kieran@dfci.harvard.edu |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009447 | Neuroblastoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D011345 | Fenofibrate |
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D010636 | Phenols |
| D007659 | Ketones |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Low Grade Glioma |
|
| Bone Tumors |
|
| Medulloblastoma/PNET |
|
| Neuroblastoma |
|
| Leukemia/Lymphoma |
|
| Miscellaneous CNS Tumors |
|
| Miscellaneous non-CNS Tumors |
|
|
|
|
|
|
|