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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| MSKCC-01042 | |||
| CTI-1059 | |||
| NCI-G01-2014 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating children who have advanced neuroblastoma or other solid tumors.
OBJECTIVES:
OUTLINE: Patients are stratified according to type of disease (neuroblastoma with progressive disease vs neuroblastoma with stable refractory disease vs other solid tumor).
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for 1 year and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arsenic Trioxide | Experimental | Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arsenic trioxide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment | 1 year |
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DISEASE CHARACTERISTICS:
Histologically confirmed neuroblastoma or other pediatric solid tumor (nonmyeloid and nonlymphoid) including the following:
Relapsed from or resistant to prior standard anticancer therapy and/or no known standard therapy available
Measurable disease (e.g., solid mass with definable dimensions) OR
Evaluable disease (e.g., bone marrow involvement or malignant pleural effusion)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Brian H. Kushner, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arsenic Trioxide | Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arsenic Trioxide | Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment | Posted | Number | participants | 1 year |
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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 | Arsenic Trioxide | Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter. | 12 | 22 | 14 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Infection NOS | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
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| Neuralgia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
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| Neutrophil count decrease | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders - Other, specify Respiratory disorder | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
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| Conjunctivitis | Eye disorders | CTCAE (2.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Dry Eye | Eye disorders | CTCAE (2.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Gastrointestinal other | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
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| Infection w/o neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Neurology, other | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Pain, other | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Purpura | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
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| Mucositis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Kushner | Memorial Sloan Kettering Cancer Center | 212-639-6793 | kushnerb@mskcc.org |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D007680 | Kidney Neoplasms |
| D008113 | Liver Neoplasms |
| D009447 | Neuroblastoma |
| D010051 | Ovarian Neoplasms |
| D012175 | Retinoblastoma |
| D012509 | Sarcoma |
| D012516 | Osteosarcoma |
| D018197 | Hepatoblastoma |
| D009396 | Wilms Tumor |
| D058405 | Desmoplastic Small Round Cell Tumor |
| D008527 | Medulloblastoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D013724 | Teratoma |
| D013736 | Testicular Neoplasms |
| C562841 | Ovarian Germ Cell Cancer |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D019572 | Retinal Neoplasms |
| D005134 | Eye Neoplasms |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005910 | Glioma |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D013733 | Testicular Diseases |
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| ID | Term |
|---|---|
| D000077237 | Arsenic Trioxide |
| ID | Term |
|---|---|
| D001152 | Arsenicals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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