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This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Agent 131I-MIBG | Active Comparator | Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. |
|
| 131I-MIBG with Vincristine/Irinotecan | Active Comparator | Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. |
|
| 131I-MIBG with Vorinostat | Active Comparator | Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 131I-MIBG | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumor Response After One Course of Therapy | To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria > 30% decrease in target tumor size. Curie score was used with PR criteria > 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR. | 43-50 days from study day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3 or Greater Non-hematologic Toxicities | Compare toxicity profiles for grade 3 or greater toxicities associated with each of 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven DuBois, MD | Dana-Farber Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027-0700 | United States | ||
| Lucile Salter Packer Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34270348 | Derived | DuBois SG, Granger MM, Groshen S, Tsao-Wei D, Ji L, Shamirian A, Czarnecki S, Goodarzian F, Berkovich R, Shimada H, Villablanca JG, Vo KT, Pinto N, Mosse YP, Maris JM, Shusterman S, Cohn SL, Goldsmith KC, Weiss B, Yanik GA, Twist CJ, Irwin MS, Haas-Kogan DA, Park JR, Marachelian A, Matthay KK. Randomized Phase II Trial of MIBG Versus MIBG, Vincristine, and Irinotecan Versus MIBG and Vorinostat for Patients With Relapsed or Refractory Neuroblastoma: A Report From NANT Consortium. J Clin Oncol. 2021 Nov 1;39(31):3506-3514. doi: 10.1200/JCO.21.00703. Epub 2021 Jul 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-Agent 131I-MIBG | Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG |
| FG001 | 131I-MIBG With Vincristine/Irinotecan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 10, 2018 |
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| Vincristine | Drug |
|
| Irinotecan | Drug |
|
| Vorinostat | Drug |
|
|
| Palo Alto |
| California |
| 94304 |
| United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Children Hospital of Colorado | Aurora | Colorado | 80045 | United States |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia | 30322 | United States |
| University of Chicago, Comer Children's Hospital | Chicago | Illinois | 60637 | United States |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| C.S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4318 | United States |
| Cook Children's Healthcare System | Fort Worth | Texas | 76104 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Hospital for Sick Children | Toronto | Ontario | M5G1X8 | Canada |
Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.
131I-MIBG
Vincristine
Irinotecan
| FG002 | 131I-MIBG With Vorinostat | Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The 111 patients described as baseline participants removes the 3 ineligible patients as provided in the initial row of the participant flow module.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single-Agent 131I-MIBG | Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG |
| BG001 | 131I-MIBG With Vincristine/Irinotecan | Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan |
| BG002 | 131I-MIBG With Vorinostat | Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat |
| BG003 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | 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 | Objective Tumor Response After One Course of Therapy | To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria > 30% decrease in target tumor size. Curie score was used with PR criteria > 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR. | Number of eligible randomized patients who received 131-I-MIBG therapy | Posted | Count of Participants | Participants | 43-50 days from study day 1 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3 or Greater Non-hematologic Toxicities | Compare toxicity profiles for grade 3 or greater toxicities associated with each of 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG | Patients who were eligible, randomized, and received 131I-MIBG treatment | Posted | Count of Participants | Participants | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months |
|
All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months
The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
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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 | Single-Agent 131I-MIBG | Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG | 11 | 38 | 6 | 38 | 37 | 38 |
| EG001 | 131I-MIBG With Vincristine/Irinotecan | Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan | 17 | 36 | 12 | 36 | 35 | 36 |
| EG002 | 131I-MIBG With Vorinostat | Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat | 18 | 37 | 5 | 37 | 35 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 10000060-Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10000081-Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10002272-Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| 10002646-Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10003988-Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10007810-Catheter related infection | Infections and infestations | Systematic Assessment |
| ||
| 10010774-Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10011224-Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10012174-Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10012727-Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10013781-Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10016256-Fatigue | General disorders | Systematic Assessment |
| ||
| 10016288-Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| 10016558-Fever | General disorders | Systematic Assessment |
| ||
| 10019211-Headache | Nervous system disorders | Systematic Assessment |
| ||
| 10020943-Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10020949-Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10021018-Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10021038-Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10021059-Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10021143-Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10021328-Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10022437-Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| 10024264-Lethargy | Nervous system disorders | Systematic Assessment |
| ||
| 10025256-Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| 10028411-Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10028813-Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10029366-Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| 10033425-Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10034960-Photophobia | Eye disorders | Systematic Assessment |
| ||
| 10035528-Platelet count decreased | Investigations | Systematic Assessment |
| ||
| 10035598-Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10040752-Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| 10047700-Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10047900-Weight loss | Investigations | Systematic Assessment |
| ||
| 10048677-Buttock pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10049182-White blood cell decreased | Investigations | Systematic Assessment |
| ||
| 10049737-Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| 10059827-Rhinitis infective | Infections and infestations | Systematic Assessment |
| ||
| CLOSTRIDIUM DIFFICILE | Infections and infestations | Systematic Assessment |
| ||
| ENTEROBACTER CLOCACAE | Infections and infestations | Systematic Assessment |
| ||
| PILONIDAL CYST | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 10000060-Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10000081-Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10000636-Activated partial thromboplastin time prolonged | Investigations | Systematic Assessment |
| ||
| 10001497-Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| 10001551-Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| 10001675-Alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| 10001718-Allergic reaction | Immune system disorders | Systematic Assessment |
| ||
| 10001723-Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10001760-Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| 10002167-Anal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10002272-Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| 10002646-Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10002855-Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| 10003481-Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| 10003988-Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10005364-Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| 10005886-Blurred vision | Eye disorders | Systematic Assessment |
| ||
| 10006002-Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10006504-Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| 10007810-Catheter related infection | Infections and infestations | Systematic Assessment |
| ||
| 10007839-CD4 lymphocytes decreased | Investigations | Systematic Assessment |
| ||
| 10008496-Chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10008531-Chills | General disorders | Systematic Assessment |
| ||
| 10009887-Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10010774-Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10011224-Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10011368-Creatinine increased | Investigations | Systematic Assessment |
| ||
| 10012174-Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10012378-Depression | Psychiatric disorders | Systematic Assessment |
| ||
| 10012727-Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10013573-Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| 10013781-Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10013786-Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| 10013911-Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| 10013946-Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10013963-Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10014020-Ear pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| 10014222-Edema face | General disorders | Systematic Assessment |
| ||
| 10014383-Electrocardiogram QT corrected interval prolonged | Investigations | Systematic Assessment |
| ||
| 10015090-Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10015958-Eye pain | Eye disorders | Systematic Assessment |
| ||
| 10016059-Facial pain | General disorders | Systematic Assessment |
| ||
| 10016256-Fatigue | General disorders | Systematic Assessment |
| ||
| 10016288-Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| 10016558-Fever | General disorders | Systematic Assessment |
| ||
| 10016778-Floaters | Eye disorders | Systematic Assessment |
| ||
| 10016791-Flu like symptoms | General disorders | Systematic Assessment |
| ||
| 10016825-Flushing | Vascular disorders | Systematic Assessment |
| ||
| 10017076-Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| 10017577-Gait disturbance | General disorders | Systematic Assessment |
| ||
| 10019211-Headache | Nervous system disorders | Systematic Assessment |
| ||
| 10019245-Hearing impaired | Ear and labyrinth disorders | Systematic Assessment |
| ||
| 10019450-Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| 10020039-Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10020587-Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10020639-Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10020647-Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10020670-Hypermagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10020680-Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10020772-Hypertension | Vascular disorders | Systematic Assessment |
| ||
| 10020870-Hypertriglyceridemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10020943-Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10020949-Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10021005-Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10021018-Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10021028-Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10021038-Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10021059-Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10021097-Hypotension | Vascular disorders | Systematic Assessment |
| ||
| 10021114-Hypothyroidism | Endocrine disorders | Systematic Assessment |
| ||
| 10021143-Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10021328-Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10022402-INR increased | Investigations | Systematic Assessment |
| ||
| 10022437-Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| 10022998-Irritability | General disorders | Systematic Assessment |
| ||
| 10024264-Lethargy | Nervous system disorders | Systematic Assessment |
| ||
| 10025256-Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| 10025258-Lymphocyte count increased | Investigations | Systematic Assessment |
| ||
| 10025482-Malaise | General disorders | Systematic Assessment |
| ||
| 10028130-Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10028411-Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10028735-Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10028813-Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10028836-Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10029366-Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| 10030980-Oral hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10031009-Oral pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10033371-Pain | General disorders | Systematic Assessment |
| ||
| 10033425-Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10033987-Paresthesia | Nervous system disorders | Systematic Assessment |
| ||
| 10034310-Penile pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| 10034620-Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| 10034960-Photophobia | Eye disorders | Systematic Assessment |
| ||
| 10035528-Platelet count decreased | Investigations | Systematic Assessment |
| ||
| 10035598-Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10036790-Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10037032-Proteinuria | Renal and urinary disorders | Systematic Assessment |
| ||
| 10037087-Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| 10037868-Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| 10038064-Rectal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10038072-Rectal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10038695-Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10040047-Sepsis | Infections and infestations | Systematic Assessment |
| ||
| 10040741-Sinus bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| 10040752-Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| 10040865-Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| 10040872-Skin infection | Infections and infestations | Systematic Assessment |
| ||
| 10041232-Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10041349-Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| 10041367-Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| 10042112-Stomach pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10042458-Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| 10044055-Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10045158-Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| 10046300-Upper respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| 10046539-Urinary frequency | Renal and urinary disorders | Systematic Assessment |
| ||
| 10046555-Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| 10046571-Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| 10047700-Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| 10047900-Weight loss | Investigations | Systematic Assessment |
| ||
| 10048677-Buttock pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10048994-Bladder spasm | Renal and urinary disorders | Systematic Assessment |
| ||
| 10049182-White blood cell decreased | Investigations | Systematic Assessment |
| ||
| 10050068-Edema limbs | General disorders | Systematic Assessment |
| ||
| 10051792-Infusion related reaction | General disorders | Systematic Assessment |
| ||
| 10054482-Neck edema | General disorders | Systematic Assessment |
| ||
| 10056910-GGT increased | Investigations | Systematic Assessment |
| ||
| 10061322-Optic nerve disorder | Eye disorders | Systematic Assessment |
| ||
| 10062225-Urinary tract pain | Renal and urinary disorders | Systematic Assessment |
| ||
| 10062466-Localized edema | General disorders | Systematic Assessment |
| ||
| 10062501-Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| 10062572-Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10065764-Mucosal infection | Infections and infestations | Systematic Assessment |
| ||
| 10065776-Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10065780-Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| 10065838-Middle ear inflammation | Ear and labyrinth disorders | Systematic Assessment |
| ||
| 10065973-Iron overload | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| 10066874-Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| ADJUSTMENT DISORDER | Psychiatric disorders | Systematic Assessment |
| ||
| C DIFFICILE | Infections and infestations | Systematic Assessment |
| ||
| CATHETER RELATED PAIN | Renal and urinary disorders | Systematic Assessment |
| ||
| CHEST DISCOMFORT, ""TIGHTNESS"" | General disorders | Systematic Assessment |
| ||
| CLOSTRIDIUM DIFICILE | Infections and infestations | Systematic Assessment |
| ||
| CONCERN FOR DISEASE PROGRESSION AS INDICATED BY INTERVAL INCREASE IN THE SIZE OF HER OCCIPITAL MASS | General disorders | Systematic Assessment |
| ||
| DISEASE PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| DRY CRACKED LIPS | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| DYSURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| ECZEMA | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| ENTEROBACTER CLOACAE | Infections and infestations | Systematic Assessment |
| ||
| HYPERPHOSPHATEMIA | Investigations | Systematic Assessment |
| ||
| INFLUENZA A | Infections and infestations | Systematic Assessment |
| ||
| INJECTED EYE | Eye disorders | Systematic Assessment |
| ||
| INJURY TO LEFT WRIST | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| IRRITATION AROUND CATHETER | General disorders | Systematic Assessment |
| ||
| JAW PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| KETONURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| MALNUTRITION - ANOREXIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| MULTIPLE BACTERIAL INFECTIONS (ENTEROBACTER, CITROBACTER, KLEBSIELLA, GPC, GVC) | Infections and infestations | Systematic Assessment |
| ||
| MURMUR | Cardiac disorders | Systematic Assessment |
| ||
| ODD/ANXIETY | Psychiatric disorders | Systematic Assessment |
| ||
| PAIN | General disorders | Systematic Assessment |
| ||
| PAIN IN EXTREMITY -RIGHT FOOT | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| PAIN RIGHT SIDE JAW | General disorders | Systematic Assessment |
| ||
| PAIN, LEG | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| PAPULOERYTHEMATOUS LESIONS - LEFT CHEEK | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| PARAPHIMOSIS | Reproductive system and breast disorders | Systematic Assessment |
| ||
| PAROTIDITIS | Infections and infestations | Systematic Assessment |
| ||
| PILONIDAL CYST | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| RASH - CHEST | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| RASH - UPPER CHEST AND BACK | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| RESPIRATORY DEPRESSION FROM SEDATION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RHINORRHEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RHINOVIRUS | Infections and infestations | Systematic Assessment |
| ||
| RIB PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| SCRATCH | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| STOMACH CRAMPING | Gastrointestinal disorders | Systematic Assessment |
| ||
| UNCOMPENSATED HYPOTHYROIDISM | Endocrine disorders | Systematic Assessment |
| ||
| URETHRAL TRAUMA | Renal and urinary disorders | Systematic Assessment |
| ||
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| NANT Medical Director | New Advances in Neuroblastoma Therapy | 3233615687 | nantops@chla.usc.edu |
| Feb 23, 2022 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D019797 | 3-Iodobenzylguanidine |
| D014750 | Vincristine |
| D000077146 | Irinotecan |
| D000077337 | Vorinostat |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007462 | Iodobenzenes |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006847 | Hydrocarbons, Iodinated |
| D006846 | Hydrocarbons, Halogenated |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D002166 | Camptothecin |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
|
|