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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA103250 | U.S. NIH Grant/Contract | View source | |
| JT 1280 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization). It is hoped with this novel approach that:
Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunoembolization | Experimental | Liver embolization treatment with injection of GM-CSF. |
|
| Plain embolization | Active Comparator | Liver embolization with normal saline injected in place of GM-CSF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GM-CSF | Drug | 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response of Liver Metastases | Complete response: Disappearance of all target and non-target liver lesions Partial response: >= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions Stable disease: Absence of change which would qualify as response or progression Progression: >= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions >= 10mm in the treated lobe(s) | Every 8 weeks |
| Overall Response Rate | Clinical response in the liver metastases will be evaluated after every two embolizations using CT scans or MRI of the abdomen. The sum of the longest diameter (LD) of up to 6 target lesions will be used to determine response. Target indicator lesions will be identified and measured as baseline prior to the first embolization. The same target lesions will then be measured 3 to 4 weeks after every two treatments. The sum of the baseline LDs will be compared to the sum of the LDs after every two treatments. | Baseline then 3 to 4 weeks after every 2 treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Measured from the start of the treatment to death of patients | Baseline to death |
| Median Progression Free Survival | Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takami Sato, M.D., Ph.D. | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19317 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immunoembolization | Liver embolization treatment with injection of GM-CSF. GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver. Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery |
| FG001 | Plain Embolization | Liver embolization with normal saline injected in place of GM-CSF Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immunoembolization | Liver embolization treatment with injection of GM-CSF. GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver. Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 of Liver Metastases | Complete response: Disappearance of all target and non-target liver lesions Partial response: >= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions Stable disease: Absence of change which would qualify as response or progression Progression: >= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions >= 10mm in the treated lobe(s) | Posted | Number | participants | Every 8 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 | Immunoembolization | Liver embolization treatment with injection of GM-CSF. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Takami Sato, MD | Thomas Jefferson University | 215-955-8874 | Takami.Sato@jefferson.edu |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
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| Embolization | Procedure | A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery |
|
|
| Baseline to time of progression |
| Systemic Progression Free Survival | Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s). | Baseline to time of progression |
| BG001 | Plain Embolization | Liver embolization with normal saline injected in place of GM-CSF Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Plain Embolization | Liver embolization with normal saline injected in place of GM-CSF Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery |
|
|
| Primary | Overall Response Rate | Clinical response in the liver metastases will be evaluated after every two embolizations using CT scans or MRI of the abdomen. The sum of the longest diameter (LD) of up to 6 target lesions will be used to determine response. Target indicator lesions will be identified and measured as baseline prior to the first embolization. The same target lesions will then be measured 3 to 4 weeks after every two treatments. The sum of the baseline LDs will be compared to the sum of the LDs after every two treatments. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline then 3 to 4 weeks after every 2 treatments |
|
|
|
| Secondary | Overall Survival | Measured from the start of the treatment to death of patients | Posted | Median | 95% Confidence Interval | months | Baseline to death |
|
|
|
| Secondary | Median Progression Free Survival | Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s). | Posted | Median | 95% Confidence Interval | months | Baseline to time of progression |
|
|
|
| Secondary | Systemic Progression Free Survival | Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s). | Posted | Median | 95% Confidence Interval | months | Baseline to time of progression |
|
|
|
| 3 |
| 26 |
| 26 |
| 26 |
| EG001 | Plain Embolization | Liver embolization with normal saline injected in place of GM-CSF Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery | 5 | 27 | 23 | 27 |
| Aneurysms | Blood and lymphatic system disorders |
|
| Death | General disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Elevated liver enzymes | Hepatobiliary disorders |
|
| Fever | General disorders |
|
| Liver pain | Hepatobiliary disorders |
|
| Angioedema | Skin and subcutaneous tissue disorders |
|
| Anorexia | General disorders |
|
| Anxiety | Psychiatric disorders |
|
| Athritis | Musculoskeletal and connective tissue disorders |
|
| Back pain | General disorders |
|
| Belching | Gastrointestinal disorders |
|
| Bleeding | General disorders |
|
| Bleeding at procedure site | General disorders |
|
| Bloating | Gastrointestinal disorders |
|
| Blurred vision | Eye disorders |
|
| Bradycardia | Cardiac disorders |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders |
|
| Bruising | Skin and subcutaneous tissue disorders |
|
| Bruising at cath site | Skin and subcutaneous tissue disorders |
|
| Burning upper quadrant pain | General disorders |
|
| Cellulitis | Skin and subcutaneous tissue disorders |
|
| Chills/rigors | General disorders |
|
| Cold | Respiratory, thoracic and mediastinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Decreased granulocytes | Blood and lymphatic system disorders |
|
| Decreased hemoglobin | Blood and lymphatic system disorders |
|
| Decreased visual acuity | Eye disorders |
|
| Decreased WBC | Blood and lymphatic system disorders |
|
| Delayed healing of insertion site | General disorders |
|
| Depression | Psychiatric disorders |
|
| Diaphoresis | General disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Disequilibrium | General disorders |
|
| Dizziness | General disorders |
|
| Drug allergy | General disorders |
|
| Dry mouth | General disorders |
|
| Dysgeusia | General disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Edema | Skin and subcutaneous tissue disorders |
|
| Epigastric pain | General disorders |
|
| Fatigue | General disorders |
|
| Fever | General disorders |
|
| Flatulence | Gastrointestinal disorders |
|
| Flu | General disorders |
|
| Fluid overload | Blood and lymphatic system disorders |
|
| Fungal nail infection | Infections and infestations |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders |
|
| Headache | General disorders |
|
| Hearing loss | Ear and labyrinth disorders |
|
| Heart palpitations | Cardiac disorders |
|
| Hematoma | Skin and subcutaneous tissue disorders |
|
| Hoarseness | General disorders |
|
| Hot flashes | General disorders |
|
| Hyperglycemia | Blood and lymphatic system disorders |
|
| Hypertension | Blood and lymphatic system disorders |
|
| Hypoalbuminemia | Blood and lymphatic system disorders |
|
| Hypotension | Blood and lymphatic system disorders |
|
| Increased bilirubin | Blood and lymphatic system disorders |
|
| Increased alkaline phosphatase | Blood and lymphatic system disorders |
|
| Increased creatinine | Blood and lymphatic system disorders |
|
| Increased SGOT | Blood and lymphatic system disorders |
|
| Increased SGPT | Blood and lymphatic system disorders |
|
| Dyspepsia | Gastrointestinal disorders |
|
| Insomnia | General disorders |
|
| Irritation | General disorders |
|
| Joint pain | General disorders |
|
| Lethargy | General disorders |
|
| Leukopenia | Blood and lymphatic system disorders |
|
| Lymphpenia | Blood and lymphatic system disorders |
|
| Muscle cramp | General disorders |
|
| Muscle pain | General disorders |
|
| Nausea | General disorders |
|
| Neuropathy | Nervous system disorders |
|
| Neutropenia | Blood and lymphatic system disorders |
|
| Night sweats | General disorders |
|
| Nose bleed | General disorders |
|
| Orthostatic hypotension | General disorders |
|
| Pain | General disorders |
|
| Personality change | Psychiatric disorders |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders |
|
| Pruritis | Skin and subcutaneous tissue disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Sensitivity to heat | General disorders |
|
| Sinus allergies | General disorders |
|
| Sinus pain | General disorders |
|
| Sinus tachycardia | Cardiac disorders |
|
| Skin infection | Infections and infestations |
|
| Slurred speech | General disorders |
|
| Sprained ankle | General disorders |
|
| Stiff neck | General disorders |
|
| Sweating | General disorders |
|
| Swollen knee | General disorders |
|
| Tachycardia | General disorders |
|
| Thrombocytopenia | Blood and lymphatic system disorders |
|
| Upper respiratory infection | General disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Weakness | General disorders |
|
| Weight loss | General disorders |
|
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| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D016207 |
| Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |