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result sql = A critical examination of the results from the Harvard-MIT NCT program phase I clinical trial of neutron capture therapy for intracranial disease.
A critical examination of the results from the Harvard-MIT NCT program phase I clinical trial of neutron capture therapy for intracranial disease.
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char = r;code = 114
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char = a;code = 97
char = l;code = 108
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char = n;code = 110
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char = t;code = 116
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char = P;code = 80
char = A;code = 65
char = -;code = 45
char = f;code = 102
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char = ,;code = 44
char = ;code = 32
char = w;code = 119
char = a;code = 97
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char = u;code = 117
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char = e;code = 101
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char = t;code = 116
char = h;code = 104
char = r;code = 114
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char = a;code = 97
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char = s;code = 115
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char = o;code = 111
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char = o;code = 111
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char = e;code = 101
char = r;code = 114
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char = 1;code = 49
char = ;code = 32
char = h;code = 104
char = ;code = 32
char = (;code = 40
char = 1;code = 49
char = 0;code = 48
char = ;code = 32
char = s;code = 115
char = u;code = 117
char = b;code = 98
char = j;code = 106
char = e;code = 101
char = c;code = 99
char = t;code = 116
char = s;code = 115
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char = ,;code = 44
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char = 3;code = 51
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char = 0;code = 48
char = ;code = 32
char = m;code = 109
char = g;code = 103
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char = k;code = 107
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char = ;code = 32
char = o;code = 111
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char = e;code = 101
char = r;code = 114
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char = 1;code = 49
char = .;code = 46
char = 5;code = 53
char = ;code = 32
char = h;code = 104
char = ;code = 32
char = (;code = 40
char = t;code = 116
char = w;code = 119
char = o;code = 111
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char = s;code = 115
char = u;code = 117
char = b;code = 98
char = j;code = 106
char = e;code = 101
char = c;code = 99
char = t;code = 116
char = s;code = 115
char = );code = 41
char = ,;code = 44
char = ;code = 32
char = o;code = 111
char = r;code = 114
char = ;code = 32
char = 3;code = 51
char = 5;code = 53
char = 0;code = 48
char = ;code = 32
char = m;code = 109
char = g;code = 103
char = ;code = 32
char = k;code = 107
char = g;code = 103
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char = -;code = 45
char = 1;code = 49
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char = ;code = 32
char = o;code = 111
char = v;code = 118
char = e;code = 101
char = r;code = 114
char = ;code = 32
char = 1;code = 49
char = .;code = 46
char = 5;code = 53
char = -;code = 45
char = 2;code = 50
char = ;code = 32
char = h;code = 104
char = ;code = 32
char = (;code = 40
char = 1;code = 49
char = 0;code = 48
char = ;code = 32
char = s;code = 115
char = u;code = 117
char = b;code = 98
char = j;code = 106
char = e;code = 101
char = c;code = 99
char = t;code = 116
char = s;code = 115
char = );code = 41
char = .;code = 46
char = ;code = 32
char = T;code = 84
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = p;code = 112
char = h;code = 104
char = a;code = 97
char = r;code = 114
char = m;code = 109
char = a;code = 97
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char = e;code = 101
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char = i;code = 105
char = c;code = 99
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char = p;code = 112
char = r;code = 114
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char = f;code = 102
char = i;code = 105
char = l;code = 108
char = e;code = 101
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char = ;code = 32
char = 1;code = 49
char = 0;code = 48
char = B;code = 66
char = ;code = 32
char = i;code = 105
char = n;code = 110
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char = b;code = 98
char = l;code = 108
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char = a;code = 97
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char = y;code = 121
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char = r;code = 114
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char = r;code = 114
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char = C;code = 67
char = r;code = 114
char = a;code = 97
char = n;code = 110
char = i;code = 105
char = a;code = 97
char = l;code = 108
char = ;code = 32
char = N;code = 78
char = C;code = 67
char = T;code = 84
char = ;code = 32
char = c;code = 99
char = a;code = 97
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char = f;code = 102
char = f;code = 102
char = e;code = 101
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char = s;code = 115
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char = s;code = 115
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char = w;code = 119
char = i;code = 105
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char = g;code = 103
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char = N;code = 78
char = C;code = 67
char = T;code = 84
char = .;code = 46
char = <;code = 60
char = b;code = 98
char = r;code = 114
char = /;code = 47
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result sql = A phase I trial was designed to evaluate normal tissue tolerance to neutron capture therapy (NCT); tumor response was also followed as a secondary endpoint. Between July 1996 and May 1999, 24 subjects were entered into a phase I trial evaluating cranial NCT in subjects with primary or metastatic brain tumors. Two subjects were excluded due to a decline in their performance status and 22 subjects were irradiated at the MIT Nuclear Reactor Laboratory. The median age was 56 years (range 24-78). All subjects had a pathologically confirmed diagnosis of either glioblastoma (20) or melanoma (2) and a Karnofsky of 70 or higher. Neutron irradiation was delivered with a 15 cm diameter epithermal beam. Treatment plans varied from 1 to 3 fields depending upon the size and location of the tumor. The 10B carrier, L-p-boronophenylalanine-fructose (BPA-f), was infused through a central venous catheter at doses of 250 mg kg(-1) over 1 h (10 subjects), 300 mg kg(-1) over 1.5 h (two subjects), or 350 mg kg(-1) over 1.5-2 h (10 subjects). The pharmacokinetic profile of 10B in blood was very reproducible and permitted a predictive model to be developed. Cranial NCT can be delivered at doses high enough to exhibit a clinical response with an acceptable level of toxicity. Acute toxicity was primarily associated with increased intracranial pressure; late pulmonary effects were seen in two subjects. Factors such as average brain dose, tumor volume, and skin, mucosa, and lung dose may have a greater impact on tolerance than peak dose alone. Two subjects exhibited a complete radiographic response and 13 of 17 evaluable subjects had a measurable reduction in enhanced tumor volume following NCT.

Publication: J. Neurooncol. 2003 Mar-Apr ;62(1-2)::111-21.
Publication Date: 2003 Mar-Apr
Study Author(s): Busse, Paul M;Harling, Otto K;Palmer, Matthew R;Kiger, W S;Kaplan, Jody;Kaplan, Irving;Chuang, Cynthia F;Goorley, J Tim;Riley, Kent J;Newton, Thomas H;Santa Cruz, Gustavo A;Lu, Xing-Qi;Zamenhof, Robert G;
Institution: Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA. [email protected]
Shortcut link to this study:
A phase I trial was designed to evaluate normal tissue tolerance to neutron capture therapy (NCT); tumor response was also followed as a secondary endpoint. Between July 1996 and May 1999, 24 subjects were entered into a phase I trial evaluating cranial NCT in subjects with primary or metastatic brain tumors. Two subjects were excluded due to a decline in their performance status and 22 subjects were irradiated at the MIT Nuclear Reactor Laboratory. The median age was 56 years (range 24-78). All subjects had a pathologically confirmed diagnosis of either glioblastoma (20) or melanoma (2) and a Karnofsky of 70 or higher. Neutron irradiation was delivered with a 15 cm diameter epithermal beam. Treatment plans varied from 1 to 3 fields depending upon the size and location of the tumor. The 10B carrier, L-p-boronophenylalanine-fructose (BPA-f), was infused through a central venous catheter at doses of 250 mg kg(-1) over 1 h (10 subjects), 300 mg kg(-1) over 1.5 h (two subjects), or 350 mg kg(-1) over 1.5-2 h (10 subjects). The pharmacokinetic profile of 10B in blood was very reproducible and permitted a predictive model to be developed. Cranial NCT can be delivered at doses high enough to exhibit a clinical response with an acceptable level of toxicity. Acute toxicity was primarily associated with increased intracranial pressure; late pulmonary effects were seen in two subjects. Factors such as average brain dose, tumor volume, and skin, mucosa, and lung dose may have a greater impact on tolerance than peak dose alone. Two subjects exhibited a complete radiographic response and 13 of 17 evaluable subjects had a measurable reduction in enhanced tumor volume following NCT.
PMID: 12749707

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