[c09aa8]: / clusters / 9knumclustersv2 / clust_55.txt

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Patients must have at least one cutaneous or subcutaneous tumor, measuring . to . cm in the longest diameter, or a palpable lymph node. At least one tumor must qualify as an index lesion that can be accurately and reproducibly measured in two dimensions for which the longest diameter is . mm (. mm in short axis diameter [SAD] for lymph nodes), and be amenable to intratumoral injection.
At least cutaneous or subcutaneous Injectable Lesion with longest diameter at least mm.
A minimum of measurable Target Lesion (i.e., ? mm longest diameter).
At least one endoscopically measurable tumor - mm in diameter
At least one bi-dimensional measurable lesion with minimum measurement of > mm in the longest diameter.
Patients must be a candidate for intralesional therapy\r\n* At least injectable cutaneous, subcutaneous, or nodal melanoma lesion >= mm in longest diameter OR\r\n* Multiple injectable melanoma lesions which in aggregate have a longest diameter of >= mm\r\n* Must have no known bleeding diathesis or coagulopathy that would make intratumoral injection unsafe
At least one baseline eligible lesion. Per RECIST criteria (version .), an eligible lesion at baseline is considered measurable when ? mm diameter in the longest diameter;
Subjects must have at least injectable cutaneous, subcutaneous soft tissue or nodal lesion >= mm in longest diameter; of note, bone lesions are not eligible for injection unless there is a soft tissue component that is amenable to injection; injectable lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment
Patients must have substantial cutaneous neurofibroma burden causing distress to the patient by disfigurement or itching; patients must have >= measurable cutaneous neurofibromas; for the purpose of this study measurability will be defined for each of the lesions selected as target lesions as a neurofibroma with a longest diameter >= mm in the longest diameter
At least two injectable lesions (amenable for direct injection or through the use of image guidance such ultrasound [US], computed tomography [CT] or magnetic resonance imaging [MRI]) defined as any injectable cutaneous, subcutaneous, nodal, or visceral melanoma lesion >= mm in longest diameter
PHASE II: Presence of at least one measurable CNS target lesion for which the following criteria are met:\r\n* At least mm in size (Note: intra-cranial disease assessments can only be performed using contrast-enhanced magnetic resonance imaging [MRI]; MRI scan slices of mm are necessary for brain metastases between and mm in size)\r\n* Lesions must be untreated or progressive according to Response Evaluation Criteria in Solid Tumors (RECIST) version . (>= % increase in longest diameter on baseline scan) after previous local therapy\r\n* Participants who are receiving corticosteroids must be on a stable or decreasing dose for at least weeks prior to the first dose of study treatment\r\n* For patients who have received local therapy to all brain lesions (e.g., whole brain radiation therapy [WBRT]), progression of pre-existing lesions based on RECIST . (> % increase in longest diameter on baseline scan) or new measurable lesions are required
Equivalent tumor diameter =< mm by CT or MRI measurement, at the time of consultation/screening (for each metastatic lesion present in the brain)
Brain lesions with an equivalent diameter of > mm in size on MRI imaging at the time of consultation/screening for protocol eligibility
For Parts A, B, D, and E: Must have at least measurable brain lesion ? millimeters (mm) in the longest diameter (LD).
Subjects must have radiographically or clinically measurable disease, defined as at least one lesion that is >= mm in diameter in at least dimension, or an aggregate of lesions that measures >= mm in diameter in at least dimension
A single measurable tumor that is at least . mm longest diameter (LDi) X . mm shortest diameter (SDi) and this tumor does not exceed . mm in LDi or SDi on Screening MRI
Subject must have measurable disease and must be a candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (? mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ? mm.
Subjects must be candidate for intralesional injection into cutaneous, subcutaneous or nodal tumors with or without image ultrasound guidance defined as one or more of the following at least injectable lesion >= mm in longest diameter, multiple injectable lesions that in aggregate have a longest diameter of >= mm
Primary tumor diameter ? mm
Patients with histologically documented metastatic melanoma with at least cutaneous lesions measuring over mm diameter; at least two lesions must be at least mm in diameter to serve as the injected disease; at least one other lesion measuring at least mm in diameter may serve as the non-injected lesion that will be measurable disease; patients will have stage IIIB or IIIC (in-transit lesions with or without nodal metastases) or stage IV MA disease with cutaneous or nodal lesions assessable for administration of LL; patients are only eligible if their melanoma deposits are not amenable to complete surgical excision; skin lesions that are mm or greater are deemed measurable however lesions that are at least mm in diameter will be preferentially utilized for LL injection
at least injectable cutaneous, subcutaneous, or nodal melanoma lesion ? mm in longest diameter
Measurable disease with greatest diameter ? mm
Patients must have measurable CNS disease, either previously untreated (not counting systemic therapy), or progressed following previous radiation treatment; lesions that have progressed after prior radiosurgery should not be selected as measurable disease if they are suspected of being radionecrosis; the following measurement criteria are required (not counting tumor edema, as visualized by contrast enhanced magnetic resonance imaging [MRI] with slice thickness of . mm or smaller, unless prospective permission is obtained from the principal investigator [PI] allowing absence of contrast or thicker slices): \r\n* At least one CNS tumor measuring mm or greater in longest diameter, OR \r\n* At least one CNS tumor measuring - mm in longest diameter, plus one or two additional CNS tumors measuring mm or greater in longest diameter, for which the sum of the longest diameters is equal to or greater than mm; patient may have additional tumors as well
Tumors measuring greater than mm in diameter
Subjects with a cluster of microcalcifications whose diameter is larger than mm.
Vessels providing flow to the tumor that are less than . mm in diameter.
at least one cutaneous lesion (each lesion ? mm in longest diameter or up to lesions having a sum of longest diameters ? mm); and/or
at least one subcutaneous lesion (each lesion ? mm in longest diameter by CT);
No lesion > mm in longest diameter; and no more than lesions
Subjects must have at least two atypical nevi of >= mm diameter and prior diagnosis of melanoma
Participants must have measurable brain disease, defined as at least one lesion that is mm in diameter
An indeterminate pulmonary nodule (IPN) ( mm diameter) on CT, or an indeterminate lung mass (> mm diameter), without prior examinations that establish that the lesion has been stable for two or more years
Less than mm distance of the tumor margin from a major vessel (> mm in diameter)\r\n* This will not be considered exclusion when irreversible electroporation (IRE) is used
Subject must be candidate for intralesional therapy administration defined as one or more of the following: i. at least injectable cutaneous, subcutaneous, or nodal SCCHN tumor ? mm in longest diameter ii. multiple injectable cutaneous, subcutaneous, or nodal SCCHN tumors that in aggregate have a longest diameter of ? mm Note: Mucosal surfaces of tumor lesions and visceral metastases should not be injected.
Subject must be a candidate for intralesional injection, defined as one or more of the following: at least injectable lesion ? mm in longest diameter multiple injectable lesions that in aggregate have a longest diameter of ? mm