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Lack of accrual
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The purpose of this study is to find out whether the monoclonal antibody 8H9 is useful in finding tumors in your body. Antibodies are protein found naturally in blood. They can fasten themselves to bacteria and viruses. They can stimulate white cells and blood proteins to kill tumors. The antibody 8H9 was made from mouse white cells. The white cells that secrete this antibody have been made to live for ever. They manufacture large amounts of 8H9 for patient use. Although other monoclonal antibodies have been safely tested in people, the antibody 8H9 has never been given to a human patient.
To test if intravenous injections of iodine-131 labeled murine monoclonal antibody 8H9 can detect primary and metastatic solid tumors. A total of 60 patients will be accrued over a period of 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 131I-8H9 and 8H9 | Experimental | This is an open-label single arm study of 131 I-8H9. injected intravenously at 10mCi/1.73m^2 dose [intended specific activity of '20mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled -8H9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 131I-8H9 | Drug | This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m^2 dose [intended specific activity of ~20 mCi/mg protein] |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Toxicity is Measured by the Total Number of Participants Affected | Safety and toxicity is measured by the total number of participants affected. Please see the adverse event table for the specifics for this protocol. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shakeel Modak, 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 | MAB 131-I LABELED 8H9 | MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MAB 131-I LABELED 8H9 | MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9. |
| 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 | Safety and Toxicity is Measured by the Total Number of Participants Affected | Safety and toxicity is measured by the total number of participants affected. Please see the adverse event table for the specifics for this protocol. | Posted | Count of Participants | 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 | MAB 131-I LABELED 8H9 | MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
Technical problems led to unreliable and uninterpretable data. Therefore, there is no data to report under Outcome Measures. Due to lack of patients accrual.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shakeel Modak | Memorial Sloan Kettering Cancer Center | 212-639-7623 | modaks@mskcc.org |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009447 | Neuroblastoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| 8H9 | Drug | administration of 50mg/1.73m^2 of unlabeled 8H9. |
|
| Participants |
|
| Gender | Count of Participants | Participants |
|
|
|
| 4 |
| 5 |
| 5 |
| 5 |
| Lymphopenia | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
|
| Hypophosphatemia | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
|
| Hemoglobin (Hgb) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
|
| Leukocyte count decreased | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
|
| Neutrophil count decreased | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
|
| Platelet count decreased | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTC-2.0 | Systematic Assessment |
|
| Serum calcium decreased | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
|
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| 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 |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |