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This study is designed to test the safety and feasibility of the simultaneous administration of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Cisplatin 120 mg/m^2 |
| |
| Doxorubicin |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Response | to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST). | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meyers Paul, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma |
| 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 |
| 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 | Radiographic Response | to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST). | Posted | Number | participants | 2 years |
|
|
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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 | All Patients | Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Calcium, low (hypocalcemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Meyers | Memorial Sloan Kettering Cancer Center | 212-639-5952 | meyersp@mskcc.org |
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| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D004317 | Doxorubicin |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Drug |
75mg/m^2 |
|
| Methotrexate | Drug | Methotrexate 12g/m^2 |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 25 |
| 40 |
| 40 |
| 40 |
| Creatinine | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Febrile neutropenia | General disorders | CTC-3.0 | Systematic Assessment |
|
| Fever (in the absence of neutropenia) | General disorders | CTC-3.0 | Systematic Assessment |
|
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | CTC-3.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTC-3.0 | Systematic Assessment |
|
| Intraoperative reproductive tract | Reproductive system and breast disorders | CTC-3.0 | Systematic Assessment |
|
| Metabolic/Lab - Other | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| ALT, SGPT | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Anorexia | General disorders | CTC-3.0 | Systematic Assessment |
|
| AST, SGOT | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Calcium, low (hypocalcemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Dermatology/Skin, other | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
|
| Febrile neutropenia | General disorders | CTC-3.0 | Systematic Assessment |
|
| Fever (in the absence of neutropenia) | General disorders | CTC-3.0 | Systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
|
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Glucose, low (hypoglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Hair loss/alopecia (scalp or body) | General disorders | CTC-3.0 | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Hemorrhage, Nose | General disorders | CTC-3.0 | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTC-3.0 | Systematic Assessment |
|
| Catheter Related Infection | Infections and infestations | CTC-3.0 | Systematic Assessment |
|
| Infection, other | Infections and infestations | CTC-3.0 | Systematic Assessment |
|
| International Normalized Ratio (INR) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Magnesium, low (hypomagnesemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Metabolic/Lab - Other | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Mucositis (Clincal exam)- Oral cavity | General disorders | CTC-3.0 | Systematic Assessment |
|
| Mucositis (Clincal exam)- Pharynx | General disorders | CTC-3.0 | Systematic Assessment |
|
| Mucositis (symptoms)- Oral cavity | General disorders | CTC-3.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Pain - Abdomen NOS | General disorders | CTC-3.0 | Systematic Assessment |
|
| Pain - Back | General disorders | CTC-3.0 | Systematic Assessment |
|
| Pain - Dental/teeth/peridontal | General disorders | CTC-3.0 | Systematic Assessment |
|
| Pain - Extremity-limb | General disorders | CTC-3.0 | Systematic Assessment |
|
| Pain - Head/headache | General disorders | CTC-3.0 | Systematic Assessment |
|
| Pain - Other | General disorders | CTC-3.0 | Systematic Assessment |
|
| Pain - Throat/pharynx/larynx | General disorders | CTC-3.0 | Systematic Assessment |
|
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Partial thromboplastin time (PTT) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
|
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Tinnitus | General disorders | CTC-3.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D003630 |
| Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |