{
"info": {
"nct_id": "NCT00572182",
"official_title": "A Phase I Study of MK-0752 in Pediatric Patients With Recurrent or Refractory CNS Malignancies",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 3 Years\nMust have maximum age of 21 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary CNS tumor\n\n * Patients with intrinsic brain stem tumors do not require histologic verification, but must have radiographic evidence of progression\n* Recurrent disease or refractory to standard therapy\n* No histologically benign brain tumors (e.g., low-grade glioma)\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status (PS) or Lansky PS 60-100%\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Absolute neutrophil count ≥ 1,000/μL\n* Platelet count ≥ 100,000/μL (unsupported)\n* Hemoglobin ≥ 8 g/dL (RBC transfusions allowed)\n* Creatinine clearance OR glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age as follows:\n\n * 0.8 mg/dL (≤ 5 years of age)\n * 1.0 mg/dL (> 5 to ≤ 10 years of age)\n * 1.2 mg/dL (> 10 to ≤ 15 years of age)\n * 1.5 mg/dL (> 15 years of age)\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age\n* ALT ≤ 2.5 times ULN for age\n* Albumin ≥ 2.5 g/dL\n* Sodium, potassium, magnesium, and calcium normal\n* Patients with neurological deficits are eligible provided these deficits are stable for ≥ 2 weeks prior to study registration\n* No clinically significant systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate study therapy or would likely interfere with the study procedures or results\n* No known hypersensitivity to MK0752\n\nPRIOR CONCURRENT THERAPY:\n\n* Recovered from the acute toxic effects of all prior therapy\n* At least 3 weeks since prior myelosuppressive anticancer chemotherapy (6 weeks for nitrosoureas)\n* At least 7 days since prior investigational or biologic agents\n\n * At least 3 weeks since prior investigational or biologic agents that have a prolonged half-life or for which the patient has experienced ≥ grade 2 myelosuppression in the treatment course preceding discontinuation of therapy\n* At least 3 half lives since prior monoclonal antibody therapy\n* At least 6 months since prior total body irradiation or craniospinal radiotherapy\n* At least 6 weeks since other prior substantial bone marrow irradiation\n* At least 2 weeks since prior local palliative radiotherapy (small volume)\n* At least 6 months since prior allogeneic bone marrow transplantation (BMT)\n\n * No evidence of active graft versus host disease\n* At least 3 months since prior autologous BMT or stem cell transplantation\n* At least 7 days since prior hematopoietic growth factors (filgrastim [G-CSF], sargramostim [GM-CSF], or erythropoietin) (14 days for long-acting formulations)\n* No prior MK0752\n* No concurrent enzyme-inducing anticonvulsant drugs (EIACDs)\n* No other concurrent anticancer or investigational drug therapy\n* Concurrent dexamethasone allowed provided patient is on a stable or decreasing dose for ≥ 2 weeks prior to study registration"
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 3 Years",
"criterions": [
{
"exact_snippets": "minimum age of 3 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 3,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 3 Years",
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"value": 3,
"unit": "Years"
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}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 21 Years",
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{
"exact_snippets": "maximum age of 21 Years",
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"requirement": {
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"expected_value": {
"operator": "<=",
"value": 21,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 21 Years",
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"operator": "<=",
"value": 21,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "* Histologically confirmed primary CNS tumor",
"criterions": [
{
"exact_snippets": "Histologically confirmed primary CNS tumor",
"criterion": "primary CNS tumor",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Histologically confirmed primary CNS tumor",
"criterion": "primary CNS tumor",
"requirement": {
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"expected_value": "histologically confirmed"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with intrinsic brain stem tumors do not require histologic verification, but must have radiographic evidence of progression",
"criterions": [
{
"exact_snippets": "intrinsic brain stem tumors",
"criterion": "intrinsic brain stem tumors",
"requirement": {
"requirement_type": "histologic verification",
"expected_value": false
}
},
{
"exact_snippets": "radiographic evidence of progression",
"criterion": "tumor progression",
"requirement": {
"requirement_type": "evidence type",
"expected_value": "radiographic"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"condition": {
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"expected_value": false
}
},
"then_criteria": {
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}
},
"else_criteria": null
}
]
}
},
{
"identified_line": {
"line": "* Recurrent disease or refractory to standard therapy",
"criterions": [
{
"exact_snippets": "Recurrent disease",
"criterion": "disease recurrence",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "refractory to standard therapy",
"criterion": "refractory to standard therapy",
"requirement": {
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}
}
]
},
"logical_structure": {
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"exact_snippets": "Recurrent disease",
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}
},
{
"exact_snippets": "refractory to standard therapy",
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}
}
]
}
},
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"identified_line": {
"line": "* No histologically benign brain tumors (e.g., low-grade glioma)",
"criterions": [
{
"exact_snippets": "No histologically benign brain tumors",
"criterion": "histologically benign brain tumors",
"requirement": {
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"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
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"criterion": "histologically benign brain tumors",
"requirement": {
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"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Karnofsky performance status (PS) or Lansky PS 60-100%",
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{
"exact_snippets": "Karnofsky performance status (PS) ... 60-100%",
"criterion": "Karnofsky performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 60,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
},
{
"exact_snippets": "Lansky PS 60-100%",
"criterion": "Lansky performance status",
"requirement": {
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{
"operator": ">=",
"value": 60,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
}
]
},
"logical_structure": {
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"exact_snippets": "Karnofsky performance status (PS) ... 60-100%",
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{
"operator": ">=",
"value": 60,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
},
{
"exact_snippets": "Lansky PS 60-100%",
"criterion": "Lansky performance status",
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{
"operator": ">=",
"value": 60,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Negative pregnancy test",
"criterions": [
{
"exact_snippets": "Negative pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Negative pregnancy test",
"criterion": "pregnancy test",
"requirement": {
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"expected_value": "negative"
}
}
]
}
},
{
"identified_line": {
"line": "* Fertile patients must use effective contraception",
"criterions": [
{
"exact_snippets": "Fertile patients",
"criterion": "fertility",
"requirement": {
"requirement_type": "status",
"expected_value": "fertile"
}
},
{
"exact_snippets": "must use effective contraception",
"criterion": "contraception use",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
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"criterion": "fertility",
"requirement": {
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"expected_value": "fertile"
}
},
"then_criteria": {
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"criterion": "contraception use",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Absolute neutrophil count ≥ 1,000/μL",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count ≥ 1,000/μL",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1000,
"unit": "/μL"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Absolute neutrophil count ≥ 1,000/μL",
"criterion": "absolute neutrophil count",
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"operator": ">=",
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"unit": "/μL"
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}
}
]
}
},
{
"identified_line": {
"line": "* Platelet count ≥ 100,000/μL (unsupported)",
"criterions": [
{
"exact_snippets": "Platelet count ≥ 100,000/μL",
"criterion": "platelet count",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "μL"
}
}
}
]
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"operator": ">=",
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}
}
}
]
}
},
{
"identified_line": {
"line": "* Hemoglobin ≥ 8 g/dL (RBC transfusions allowed)",
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{
"exact_snippets": "Hemoglobin ≥ 8 g/dL",
"criterion": "hemoglobin level",
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"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "g/dL"
}
}
},
{
"exact_snippets": "RBC transfusions allowed",
"criterion": "RBC transfusions",
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"requirement_type": "allowance",
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}
}
]
},
"logical_structure": {
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"operator": ">=",
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"unit": "g/dL"
}
}
},
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"exact_snippets": "RBC transfusions allowed",
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}
}
]
}
},
{
"identified_line": {
"line": "* Creatinine clearance OR glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age as follows:",
"criterions": [
{
"exact_snippets": "Creatinine clearance ... ≥ 70 mL/min",
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"unit": "mL/min"
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}
},
{
"exact_snippets": "glomerular filtration rate ≥ 70 mL/min",
"criterion": "glomerular filtration rate",
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"operator": ">=",
"value": 70,
"unit": "mL/min"
}
}
},
{
"exact_snippets": "serum creatinine based on age",
"criterion": "serum creatinine",
"requirement": {
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"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Creatinine clearance ... ≥ 70 mL/min",
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}
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{
"exact_snippets": "glomerular filtration rate ≥ 70 mL/min",
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}
}
},
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}
}
]
}
},
{
"identified_line": {
"line": "* 1.0 mg/dL (> 5 to ≤ 10 years of age)",
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{
"exact_snippets": "1.0 mg/dL (> 5 to ≤ 10 years of age)",
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"requirement": {
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"comparisons": [
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"operator": ">",
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]
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"logical_structure": {
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{
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},
{
"identified_line": {
"line": "* 1.2 mg/dL (> 10 to ≤ 15 years of age)",
"criterions": [
{
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{
"exact_snippets": "1.2 mg/dL",
"criterion": "serum creatinine",
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"operator": "=",
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"unit": "mg/dL"
}
}
}
]
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}
}
}
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{
"identified_line": {
"line": "* 1.5 mg/dL (> 15 years of age)",
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{
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}
},
{
"exact_snippets": "1.5 mg/dL",
"criterion": "serum creatinine level",
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"value": 1.5,
"unit": "mg/dL"
}
}
}
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}
},
{
"exact_snippets": "1.5 mg/dL",
"criterion": "serum creatinine level",
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"operator": "<=",
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"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Albumin ≥ 2.5 g/dL",
"criterions": [
{
"exact_snippets": "Albumin ≥ 2.5 g/dL",
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}
}
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},
{
"identified_line": {
"line": "* Sodium, potassium, magnesium, and calcium normal",
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{
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}
},
{
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}
},
{
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}
},
{
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}
}
]
},
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},
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}
},
{
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}
},
{
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}
}
]
}
},
{
"identified_line": {
"line": "* Patients with neurological deficits are eligible provided these deficits are stable for ≥ 2 weeks prior to study registration",
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{
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "deficits are stable for ≥ 2 weeks",
"criterion": "stability of neurological deficits",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 2,
"unit": "weeks"
}
}
}
]
},
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"condition": {
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"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "deficits are stable for ≥ 2 weeks",
"criterion": "stability of neurological deficits",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 2,
"unit": "weeks"
}
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* No clinically significant systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate study therapy or would likely interfere with the study procedures or results",
"criterions": [
{
"exact_snippets": "No clinically significant systemic illness",
"criterion": "systemic illness",
"requirement": {
"requirement_type": "severity",
"expected_value": "not clinically significant"
}
},
{
"exact_snippets": "serious infection",
"criterion": "infection",
"requirement": {
"requirement_type": "severity",
"expected_value": "not serious"
}
},
{
"exact_snippets": "significant cardiac ... dysfunction",
"criterion": "cardiac dysfunction",
"requirement": {
"requirement_type": "severity",
"expected_value": "not significant"
}
},
{
"exact_snippets": "significant ... pulmonary ... dysfunction",
"criterion": "pulmonary dysfunction",
"requirement": {
"requirement_type": "severity",
"expected_value": "not significant"
}
},
{
"exact_snippets": "significant ... hepatic ... dysfunction",
"criterion": "hepatic dysfunction",
"requirement": {
"requirement_type": "severity",
"expected_value": "not significant"
}
},
{
"exact_snippets": "significant ... other organ dysfunction",
"criterion": "other organ dysfunction",
"requirement": {
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