Patients must have at least one lesion that has not previously been irradiated (and is not within a previously radiated field) and for which palliative radiation is potentially indicated and could be safely delivered at the radiation doses specified in this protocol; this lesion must not be the only measurable lesion so that it is still possible to determine the response rate outside of the radiation treatment field; this lesion must not be within the central nervous system (CNS) (brain or spinal cord) or requiring urgent or emergent palliative radiation given the timing of radiation specified on this protocol; furthermore, this lesion: \r\n* For cohort 1 (NSCLC cohort) – the lesion to be irradiated must be in the lung, lymph nodes, adrenal gland or liver \r\n* For cohort 2 (colorectal cohort) – the lesion to be irradiated must be in the liver
Must have at least 1 lesion with measurable disease
At least 1 measurable lesion for solid tumor
Presence of measurable disease based on RECIST 1.1; subjects with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
Tumor lesion accessible for biopsy after the start of treatment. (Note: this lesion should be separate from measurable lesions that will be used for response assessment.)
Presence of at least one measurable lesion as defined by RECIST version (v)1.1; a previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the completion of irradiation
For the MTD expansion cohort, Subject must have an accessible tumor lesion(s) and consent to tumor biopsy of such a lesion(s) during screening and after starting KO-947 treatment.
The patient must have multiple sites of metastatic disease with at least one lesion amenable to treatment with stereotactic radiation therapy (SBRT) in the lung or liver and at least one lesion not being irradiated and meeting RECIST 1.1.
COHORT A: Measurable CNS disease (one intracranial lesion >= 5 mm)
COHORT B: Measurable CNS disease (one intracranial lesion >= 5 mm)
COHORT D: Measurable CNS disease (one intracranial lesion >= 5 mm) from any solid tumor
Measurable disease in the brain, defined as at least 1 lesion measuring >= 5 mm on imaging at the time of registration
Patients who underwent neurosurgery (NSGY), whole brain radiation therapy (WBRT), or stereotactic radiosurgery (SRS) to a brain lesion must have a new measurable lesion; previously surgically excised lesion/tumor bed, may be used as a measurable lesion if disease has progressed since surgery (NOTE: SRS may be done to a lesion that will not be used for response evaluation and should be done > 2 weeks prior to registration; any WBRT must have occurred > 60 days ago; any NSGY procedure must have been completed > 3 weeks prior to registration and baseline imaging)
Primary breast tumor size at least 2 centimeter (cm) in one dimension by clinical or radiographic exam; patients who have multicentric breast cancer are eligible if each lesion is ER-negative and HER2-negative; in that case, one lesion needs to be identified as the index lesion to be followed for clinical response; the index lesion must also be the lesion from which core biopsies are obtained
At least one measurable lesion.
Lesion must be sonographically visible at the time of treatment.
At least one measurable lesion as defined by RECIST version (v)1.1 criteria; previously irradiated lesions are not measurable unless the lesion has demonstrated clear progression after radiation
At least 1 measurable lesion that can be reproducibly measured in 2 dimensions
Lesion amenable to treatment with both PLA and HIGRT; for PLA treatment this requires the lesion be visible via ultrasound and/or non-contrast CT or feasible per treating physician
Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured.
At least one radiologically measurable lesion as per RECIST 1.1
Participant must have at least one biopsiable lesion in the Phase 1 portion. In the Phase 2 part of the trial, participants must have either (a) at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or (b) at least one predominantly lytic bone lesion.
Prior embolization and/or ablation; for the dose escalation, prior embolization and ablation is allowed as long as the patient has progressed with a new RECIST measurable lesion
Local radiation therapy (RT) is allowed as needed to manage symptoms appropriately, as long as there remains a measurable lesion in the CNS
Whole-brain RT may be used, without a pre-defined washout period, prior to commencement of study therapy if the lesion that has been radiated is not the sole measurable lesion, or the patient is eligible based on positive CSF cytology
Participants must have at least one RECIST v1.1 measurable non-central nervous system (CNS) based lesions; palliative radiation must be indicated for at least one measurable or non-measurable lesions (including bone lesion), and this lesion must be a candidate for radiation to a dose of 30 Gy of radiation over 5 fractions as deemed by a treating radiation oncologist; one measurable lesion must be in a location where it will not be incorporated into the radiation fields so systemic response can be assessed; however, inclusion of patients with more than 10 measurable lesions is strongly discouraged and all patients must have life expectancy > 6 months
Surgical fixation of bone lesion to be irradiated is required and indicated to provide mechanical stability
Surgical fixation of bone lesion to be irradiated is required and indicated to provide mechanical stability
Has ?1 injectable lesion which is measurable and amenable to injection and biopsy.
Phase II: Patients with advanced/metastatic tumors in the below selected indications, with at least one measurable lesion as determined by RECIST v1.1 or RANO
At least 1 measurable lesion on imaging. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
Prior radiofrequency ablation (RFA) to index lesion
At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; a previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
At least one bidimensionally measurable lesion
At least one measurable lesion at baseline
At least one extracranial measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation.
Patients with isolated tumorous CNS-LCH (including isolated DI with mass lesion in the hypothalamus-pituitary axis). In patients with already established diagnosis of LCH and radiologic finding of CNS lesions compatible with LCH, a biopsy of the lesion is not obligatory. In all other cases a biopsy of the lesion is needed for inclusion into the study
Stratum VI -- Patients with newly diagnosed SS-LCH and localization other than \multifocal bone\,isolated tumorous CNS lesion, or isolated \CNS-risk\ lesion.
Measurable metastatic gastrointestinal epithelial cancer with at least one lesion that is resectable for TIL generation, plus one other lesion that can be measured.
One previously unirradiated lesion amenable to 8 Gy x 3 radiotherapy based on dosimetric organ tolerance AND another unirradiated measurable lesion (per irRECIST) outside of the radiation field.
Have at least one measurable lesions in the liver or at least one measurable lesion in the liver and another measurable lesion elsewhere, based on RECIST version (v.) 1.1
Radiographically measurable disease by RECIST version 1.1 in at least one site not previously treated with chemoembolization, radioembolization, radiation, or other local/liver-directed procedures (i.e. must have at least one measurable target lesion, either within the liver or in a measurable metastatic site); a new area of tumor progression within or adjacent to a previously-treated lesion, if clearly measurable by a radiologist, is acceptable
NHL only- at least one measurable lesion
Have at least 1 resectable lesion to generate TIL
Patients with pathologically confirmed MF with cutaneous involvement.\r\n* Patients must have clinically measurable disease of at least 1 lesion on physical (skin) exam.\r\n* If a patient has a prior pathological diagnosis of MF and is clinically diagnosed with a new lesion, the new lesion is eligible for enrollment without additionally biopsy confirmation.
Must have at least 1 lesion with measurable disease
An irradiated lesion is considered evaluable only if it has shown enlargement since the completion of last radiation
At least one cutaneous lesion that is amenable to treatment with topical imiquimod
Measurable lesion; patients are required to have at least one measurable non-bone lesion ? 10 mm that has not been irradiated\r\n* Measurable metastatic disease documented by radiograph, computed tomography (CT) scan, positron emission tomography (PET)/CT, magnetic resonance imaging (MRI), or physical exam is required; each subject will be required to have at least one measurable lesion that has not been irradiated with a minimum size in at least one diameter of ? 10 mm for liver lesions, lung, skin, and ? 15 mm lymph node metastases; biopsy of recurrent site(s) is not required
Patients with at least two liver tumor lesions with at least one with a diameter of 2 cm or bigger, which is amendable for (super-)selective TATE as the target lesion. Alternatively, patients with one intra-hepatic lesion of 2 cm or bigger and exhapetic lesion(s) are also acceptable.
Prior local radiation therapy would be allowed as long as there is at least one non-irradiated index lesion
Must have at least one intrahepatic lesion amenable to SBRT
At least one measurable lesion as defined by RECIST version 1.1; previously irradiated lesions are not measurable unless the lesion has demonstrated clear progression after radiation
Patients may have received any previous therapy, including surgical excision, but must have histologically documented recurrence on new biopsy and a measurable lesion that meets the above criteria
at least 1 measurable lesion on imaging.
Presence of inoperable tumor lesion/s from histologically confirmed solid tumors or lymphomas, in patients with at least one lesion ? 1 cm and suitable for intra-lesional injection, who have disease progression after treatment with available therapies, or who are intolerant to such treatments
Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable/evaluable disease
At least one index lesion that will not undergo RT or ablation, and which is measurable based on RECIST 1.1
One previously unirradiated lesion amenable to radiotherapy 8 Gy x 3 and can meet dose constraints, and another unirradiated measurable lesion >= 1 cm in size outside the radiation field that can be used as measurable disease
At least one baseline eligible lesion. Per RECIST criteria (version 1.1), an eligible lesion at baseline is considered measurable when ? 10mm diameter in the longest diameter;
More than one primary lesion
Histologically confirmed diagnosis of initial or recurrent anal or vulvar high-grade squamous intraepithelial lesion diagnosed on or after 1/1/2014; study pathologist will use p16 staining as needed to rule out low-grade squamous intraepithelial lesion (LSIL) disease
Must have at least 1 lesion with measurable disease
Measurable disease requirements on scans: PCNSL subjects should have at least one measurable extranodal brain lesion; PTL subjects should have at least 1 measurable extranodal lesion or nodal lesion
At least 1 measurable lesion
Subjects must have a CTA scan confirming the PE diagnosis and with at least one measurable index lesion in a segmental or larger pulmonary artery prior to randomization;
Plan on having surgical treatment to remove the lesion
Radiological assessment within 21 days prior to study entry demonstrating measurable disease that includes at least one pulmonary lesion >= 1 cm in greatest dimension that would be amenable to SBRT and at least one measurable lesion that would be outside of the SBRT treatment fields
Patients must have at least 1 lesion that is measurable using RECIST guidelines\r\n* NOTE: A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per RECIST, and has clearly progressed\r\n* NOTE: For patients with infiltrative disease, evaluable disease needs to be confirmed by pathology if RECIST measurements cannot be made
Biopsy proven metastatic melanoma or non-squamous NSCLC with at least one untreated cerebral metastasis that is at least 5 mm AND twice the magnetic resonance imaging (MRI) slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment (“clinically evaluable lesion[s]”); an untreated brain metastasis is defined as a lesion not present at the time of whole brain radiation therapy or included in a stereotactic radiotherapy field (or within 2 mm of a treated lesion), or any lesion that is new or unequivocally progressing since prior radiation therapy
All patients should have either five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion; or other assessable disease
At least five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion; or other assessable disease
Measurable metastatic melanoma with at least one lesion that is resectable for TIL generation
At least 1 measurable lesion (as per RECIST v1.1) progressing or new since last anti-tumor therapy.
At least one tumor must qualify to be an index lesion for modified WHO criteria.
PHASE II: At least one measurable extra-CNS lesion based upon RECIST version 1.1; Note: participants with at least one CNS lesion >= 10 mm but no other measurable extra-CNS lesions will still be allowed to participate
At least 1 measurable lesion
At least 1 lesion with measurable disease at baseline
Patients must have at least one measurable site of disease, per RECIST 1.1, that has not been previously irradiated; if the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation
Must have at least 1 liver lesion amenable to SBRT with tumor size < 15 cm (single lesion or sum); up to 3 lesions will be irradiated
Patients must have at least one biopsiable measurable metastatic melanoma, lesion > 1 cm and must be amenable to undergoing serial biopsies through the course of therapy; this lesion must not be documented as one of the target lesions
Patient’s acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator)
At least one additional non-contiguous lesion to the irradiated lesion amenable to radiographic evaluation
Patients may not have received radiation to the index lesion within 1 year of enrollment
Patients who have metastatic cancer must have at least one lesion that is outside the radiation field that measures greater than one cm that can be followed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; this lesion, if it is close to the radiated lesion, must receive no more than 10% of the dose prescribed to the target lesion
Any history of systemic anti-cancer therapy (standard or experimental) completed within 30 days prior to dosing, with the exception of palliative ablation of lesion(s) as long as measurable disease lesion(s) remain for evaluation of exploratory endpoints
Prior ablative or surgical treatment of the lesion
Focal lesion visualized in its entirety colposcopically and involving =< 2 quadrants of the cervix
At least 1 measurable lesion
RAI-refractory disease on structural imaging, defined as any one of the following:\r\n* A metastatic lesion that is not radioiodine-avid on a diagnostic radioiodine scan performed prior to enrollment in the current study, or\r\n* A radioiodine-avid metastatic lesion which remained stable in size or progressed despite radioiodine treatment 6 months or more prior to entry in the study; there are no size limitations for the index lesion used to satisfy this entry criterion\r\n* The presence of at least one fluorodeoxyglucose (FDG) avid lesion
More than 1 lesion identified during baseline.
Biopsy proven metastatic melanoma or NSCLC as follows:\r\n* Patients with metastatic melanoma must have untreated brain metastases including:\r\n** At least one cerebral metastasis that requires local intervention and is amenable to craniotomy or LITT either due to symptoms, lesion size, location, edema or hemorrhage (“surgical lesion”); alternatively, a patient may be eligible if a cerebral metastasis was resected or biopsied any time prior to enrollment and there is tumor tissue available for analysis\r\n** At least one cerebral metastasis that is at least 5 mm AND twice the magnetic resonance imaging (MRI) slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment (“clinically evaluable lesion[s]”)\r\n* Patients with stage IV NSCLC with at least one cerebral metastasis that is at least 5 mm AND twice the MRI slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment (“clinically evaluable lesion[s]”)
Active herpes lesion
Ultrasound visible lesion(s)
Disease must be evaluable by metaiodobenzylguanidine (MIBG) scan; a positive MIBG scan must be present within 8 weeks prior to study entry and subsequent to any intervening therapy; if the patient has only one MIBG positive lesion and that lesion was radiated, a biopsy must be done at least 4 weeks after radiation was completed and must show viable neuroblastoma
Diffusely multifocal lesion
At least five measurable KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion
Patients must have at least one measurable CNS lesion that is asymptomatic, untreated, and does not require local therapy at the time of enrollment; measurable CNS disease is defined as a brain metastasis that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 5 mm (>= 0.5 cm) with brain magnetic resonance imaging (MRI); if the lesion is 5-10 mm in size and is the only measurable disease, MRI imaging must be performed with 1.5 mm slice thickness or less; a history of previously treated brain metastases is allowed, however any lesion present at the time of whole brain radiotherapy or included in the stereotactic radiotherapy field (or within 2 mm of the treated lesion) will NOT be considered “untreated” unless it is new or documented to have progressed unequivocally since treatment
For Parts A, B, D, and E: Must have at least 1 measurable brain lesion ?10 millimeters (mm) in the longest diameter (LD).
Patients must have measureable disease which is defined as at least one measurable lesion that can be accurately measured in 2 planes; diffuse leptomeningeal involvement (\sugar coating\) that does not allow measurement of at least one lesion in 2 planes will not be considered measurable disease
INCLUSION FOR INTRAMURAL INJECTION: \r\n* Subject must have lesion(s) amenable to HSV1716 administration by needle if superficial; by needle and/or catheter if deep or pulmonary, via interventional radiology without undue risk\r\n* Lesion(s) must meet size criteria\r\n* In the first two dose levels, subjects must have localized disease that meets size criteria; localized is defined as a single lesion; however, more than one lesion may be acceptable if they are contiguous\r\n* In the third dose level, subjects must have one to three lesions meeting size criteria\r\n* The arm (route of administration) will be chosen by the investigator and patient/parent based on multiple considerations and subject to approval by the principal investigator
Patients must have localized spinal metastasis; this includes patients with a solitary lesion, a lesion that spans two contiguous levels, a lesion with a para-spinal component, and up to three separate single vertebral levels
Have at least 1 measurable lesion of ? 1.0 cm. Confidential and Proprietary 6 ALT-803 and Pembrolizumab for NSCLC Altor BioScience Clinical Trial Protocol: QUILT-2.023
Subject has measurable disease according to RECIST 1.1 within 28 days prior to the first dose of study treatment. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
Patients must have at least one lesion not previously irradiated (and not within a previously irradiated field) for which palliative radiation to the abdomen and/or pelvis is potentially indicated and could be safely delivered at the radiation doses specified in this protocol; this lesion must not be within the central nervous system (CNS) (brain or spinal cord), bone or liver, and must not require urgent or emergent palliative radiation given the timing of radiation specified on this protocol; furthermore, this lesion must be located in the abdomen or pelvis and measure at least 2 cm (minimum dimension) and no greater than 6 cm (maximum dimension); palliative radiotherapy would entail involved-field radiotherapy to a single lesion or region to encompass gross disease; whole-abdomen radiotherapy would not be permitted; patients who received prior vaginal brachytherapy would be permitted to receive palliative pelvic radiation; in the expansion cohort at the maximum tolerated dose (MTD), this lesion must not be the only measurable lesion so that it is possible to determine the response rate outside of the radiation treatment field
Patients with just one measurable or evaluable tumour lesion that has been resected or irradiated prior to their enrolment in the study
Subjects must have at least one measurable lesion
Excluding the lesion intended to undergo radiation, subjects must have at least 1 unresectable, non-bony lesion that is measurable radio-graphically (based on RECIST 1.1).
patients with NSCLC, UC, mBC, or SCCHN must have measurable disease by RECIST v1.1 criteria with at least one uni-dimensional measurable lesion;
At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST (RECIST version 1.1) and no older than 28 days before start of the study treatment. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion.
Prior radiation treatment to the index lesion to be treated
Prior radiation which overlaps and precludes hypofractionated treatment to the index lesion
Absence of a biopsiable lesion as determined by radiologist
Patient has either measurable disease per RECIST v1.1 or at least one predominantly lytic bone lesion must be present
Must have at least 1 lesion with measurable disease
a second (distal) lesion must be accessible for baseline and on-treatment biopsy and must be distinct from the injected lesion.
The presence of radiographically measurable disease immediately prior to start of Phase I immunotherapy is not an eligibility requirement in the following situations:\r\n* In patients with NB who have documented bone marrow (BM) involvement;\r\n* In patients with NB who have MIBG-positive bony lesion(s);\r\n* In patients with OST who had to undergo resection of the pulmonary lesion(s)
Major surgery < 4 weeks or radiation therapy < 2 weeks of study entry; prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
Prior radiation allowed (no restriction on amount); measurable lesion(s) may not have been previously irradiated
For cohort 3 only, patients must be able to safely undergo pre and post-treatment biopsy, i.e., at least one readily accessible lesion or palpable lymph node metastasis arising from any solid tumor cancer or lymphoma\r\n* NOTE: this may include cutaneous and subcutaneous tumors using injection by palpation or ultrasound guidance\r\n* NOTE: the target lesion must be >= 1.5 cm on its longest diameter, be at least 5 mm thick, and have distinct borders\r\n* NOTE: deep seated lesion(s) that are deemed hazardous to inject or lesion(s) close to vital structures that might be impinged with tumor swelling are excluded as targeted tumor\r\n* NOTE: cohort 3 should be selected for patients with injectable cutaneous lesion(s), unless the patient elects not to receive IT injection and/or undergo pre and post-treatment biopsies
For escalation cohorts, if no measurable disease is present, then at least one predominantly lytic bone lesion must be present
At least one lesion in the brain that is measurable, which is defined as >= 5 x 5 mm; (prior craniotomy and surgical resection is allowed, as long as there is at least one remaining measurable lesion in the brain)
Previous radiotherapy to the lesion(s) of interest, including prior treatment with whole-brain radiation therapy (WBRT); (prior treatment with SRS is allowed if the index lesion[s] is in a different, non-contiguous location than the previously treated lesion)
Must have a skin lesion of at minimum 2 cm, in a location amenable to radiation and a minimum of 2 additional measurable skin lesions distant from the radiation site
More than one primary lesion
Patients must have at least one 1.5 cm bidimensional measurable lesion
Radiographically measurable disease by RECIST version 1.1 in at least one site not previously treated with chemoembolization, radioembolization, or other local ablative procedures (i.e. must have at least one measurable target lesion, either within the liver or in a measurable metastatic site); a new area of tumor progression within or adjacent to a previously-treated lesion, if clearly measurable by a radiologist, is acceptable
Measurable disease at least one lesion ? 1.5 cm for NHL and ALC > 5,000 for CLL
Patients must have at least one lesion that meets the definition of measurable disease by RECIST 1.1
Prior stereotactic radiotherapy (SRT) and prior excision of up to 3 melanoma brain metastases is permitted if there has been complete recovery, with no neurologic sequelae, and measurable lesions remain. Growth or change in a lesion previously irradiated will not be considered measurable. Regrowth in cavity of previously excised lesion will not be considered measurable. lesions or prior excision must have occurred ? 3 weeks before the start of dosing for this study
A minimum of 1 measurable lesion by CT or MRI
Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated
Patient has either measurable disease per RECIST 1.1 criteria OR at least one predominantly lytic bone lesion must be present
Subjects must have at least one lesion amenable to biospy
If patients have had a potential index lesion radiated, it must have progressed post radiation therapy to be used as a measurable eligibility lesion
Targeted prostate biopsy within 6 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.
Must have at least 1 lesion with measurable disease
At least one prior treatment to a central nervous system (CNS)-based lesion is required; prior therapy must be completed > 2 weeks prior to enrollment; a previously treated lesion must be demonstrated by MRI to have progressed following treatment in order to be eligible; the subsequent development of a new CNS lesion that was not previously treated will be permitted and does not require treatment followed by progression prior to enrollment; treatment of a single CNS lesion with local therapy in the context of multifocal disease is permitted as long as at least one untreated lesions meets criteria for measurable disease; patients should have received minimum of one line of systemic therapy
Patients must have at least 1 lesion that is measurable using RECIST guidelines.
At least one measurable lesion
Patient must have either measurable disease by RECIST 1.1 or at least one predominantly lytic bone lesion.
Patient has at least one measurable lesion (>= 2 cm) according to Cheson criteria
For patients with neither LM nor measurable BM: At least one measurable extracranial lesion. For patients with measurable BM but without LM: at least one measurable intracranial lesion
Hepatic lesion
The lesion is suitable for repeat measurement
Patient must have appearance of at least one new bone lesion
Phase 1 patients must have at least two measurable tumor lesions ? 1.0 cm that are accessible to biopsy. Phase 2 patients must have at least one measurable lesion (per RECIST v1.1) which may be the same site that is used for the intratumoral injections.
Patient has at least one measurable lesion (>= 2 cm) according to Lugano classification
At least one index lesion that will not undergo RT and which is measurable based on RECIST 1.1
Absence of lytic bone lesion
Radiation therapy within 2 weeks of starting the study treatment; prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per RECIST version 1.1
At least one index lesion that will not undergo RT or ablation, and which is measurable based on RECIST 1.1
If no measurable disease is present, then at least one predominantly lytic bone lesion must be present
Visible uptake in at least one lesion on bone scanning prior to radium therapy
At least 1 measurable lesion at baseline;
In addition to index lesion, there are >= 1 measurable lesion(s)
Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator)
Subjects must have at least 1 lesion
Skin lesion involvement of at least 2% of BSA accessible for topical application of study drug
At least 1 measurable lesion at baseline
At least one lesion, not previously irradiated.
RAI-refractory disease on structural imaging, defined as any one of the following: \r\n* A metastatic lesion that is not radioiodine-avid on a diagnostic radioiodine scan performed up to 2 years prior to enrollment in the current study, or \r\n* A radioiodine-avid metastatic lesion which remained stable in size or progressed despite radioiodine treatment 6 months or more prior to entry in the study; there are no size limitations for the index lesion used to satisfy this entry criterion\r\n* The presence of at least one fluorodeoxyglucose (FDG) avid lesion with a maximum standardized uptake value (SUVmax) >= 5
a.For Escalation Phase: At least one lesion (measurable and/or non-measurable) b.For Expansion Phase: At least one measurable lesion.
Measurable (RECIST) indicator lesion not previously irradiated.
Patient must have either: • Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (Tumor lesions previously irradiated or subjected to other locoregional therapy will only be considered measurable if disease progression at the treated site after completion of therapy is clearly documented). OR • If no measurable disease is present, then at least one predominantly lytic bone lesion must be present (Patients with no measurable disease and only one predominantly lytic bone lesion that has been previously irradiated are eligible if there is documented evidence of disease progression of the bone lesion after irradiation).
At least one measurable untreated lesion
Patients must have measurable disease in the brain, defined as at least 1 lesion measuring >= 5 mm on imaging
Patients who underwent radiosurgery to treat a progressive lesion must have confirmation of tumor by tissue, magnetic resonance spectroscopy (MRS), magnetic resonance (MR) perfusion or positron emission tomography (PET) and the lesion must be measurable; NOTE: radiosurgery may be done to a lesion that will not be used for response evaluation and should be done > 2 weeks prior to enrollment
At least one measurable lesion on screening CT or MRI
Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
Subjects with metastatic disease limited to bone are ineligible unless at least one lytic lesion with identifiable soft tissue components that can be evaluated by MRI or CT, that is measurable (>= 15 mm at baseline) and can be followed serially by RECIST v 1.1
At least one measurable lesion as defined by modified RECIST version 1.1; previously irradiated lesions are not measurable unless the lesion is new or has demonstrated clear progression after radiation
At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST (RECIST version 1.1), and modified RECIST for HCC. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion.
Subjects must have at least 1 measurable lesion.
Dose Expansion phase: At least 1 measurable lesion which has not been treated previously with radiotherapy. A newly arising lesion in a previously irradiated field is acceptable
Certain type(s) of non-measurable lesion(s), if the only one(s).
Treatment of any bone lesion is permissible if it is anticipated that the dosimetry guidelines can be met
Patient has at least one measurable nodal lesion (>= 2.0 cm)
Evidence of objective disease. A measurable lesion is not necessary.
a) Dose Evaluation Portion: Patients should have at least one lesion accessible for intratumoral injection and biopsy. b) Melanoma Expansion Cohort: Patients must have at least one target lesion by Response Evaluation Criteria for Solid Tumors (RECIST v1.1), with at least one lesion accessible for intratumoral injection. Tumor biopsies are not required in the expansion cohort.
Both naive and previous systemically treated patients are included \r\n* Prior chemotherapy or immunotherapy is permitted\r\n* Prior investigational agents are permitted, however, no prior treatment with targeted therapies directed to c-KIT/PDGFR allowed (e.g., imatinib or sunitinib)\r\n* Limb perfusion allowed\r\n* If radiation has been administered to a lesion, there must be radiographic evidence of progression of that lesion in order for that lesion to constitute measurable disease or to be included in the measured target lesions
Patients are only eligible if complete tumor resection is not feasible, or if a patient with a surgical option refuses surgery; patients must have measurable residual tumor present; for the purpose of this study a measurable lesion will be defined as a lesion of at least 3 cm measured in one dimension; evidence of recurrent or progressive disease is NOT necessary; patients must be at least 21 days from surgery, if performed, prior to receiving their first dose of study drug
At least one measurable lesion
All patients must have at least one lesion deemed safe to biopsy and be willing to undergo mandatory baseline biopsy; it is preferred that this lesion be a lesion that progressed or arose while on the prior PARP therapy
Extra-osseous extension of metastatic lesion is >10mm,
At least one lesion measurable by RECIST not previously irradiated (Monotherapy and in Cohorts A and B)
Previous local therapy of any KS-indicator lesion unless the lesion has clearly progressed since treatment; any prior local treatment to indicator lesions regardless of the elapsed time is not allowed unless there is evidence of clear-cut progression of said lesion
Measurable metastatic melanoma with at least one lesion that is resectable for TIL generation; the lesion must be at least 1 cm in diameter that can be surgically removed with minimal morbidity (defined as any operation for which expected hospitalization =< 7 days)
Confirmed and measurable metastatic melanoma with at least one measurable lesion for evaluation of response
Has at least one confirmed measurable metastatic lesion
Previous local therapy of any KS-indicator lesion unless the lesion has clearly progressed since that local treatment; any prior local treatment to indicator lesions regardless of the elapsed time should not be allowed unless there is evidence of clear-cut progression of said lesion
At least one bidimensionally measurable lesion
Prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated
Lytic lesion requiring an impending orthopedic intervention
Subjects must have at least 1 measurable lesion.
At least 2 sites of measurable disease per Cheson criteria (must measure at least 1.5 cm in any diameter or 1.0 cm in the shortest diameter if one of the diameters is not ? 1.5 cm), one of which must be palpable and easily accessible in a low-risk site (eg, inguinal, axillary, cervical, subcutaneous) for intratumoral injection (denoted as \Lesion A\ in Treatment Cycle 1) and at least one additional untreated lesion that is located outside the radiation field of the treated lesion (Lesion A) and is accessible for an FNA aspirate.
Lytic lesion requiring an impending orthopedic intervention
At least one radiologically-confirmed and measurable metastatic brain lesion ( ? 0.5 cm)
Measurable disease, as determined by radiologist evaluator, with at least 1 unidimensional measurable lesion (target lesion) by RECIST v.1.1 that has not previously been irradiated or biopsied
Documented presence of at least one metastatic lesion of the humerus.
At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area
Patients must have at least one lesion suitable for perfusion CT; the lesion should be greater than or equal to 3 cm in size in the cranial caudal direction
Lytic lesion requiring an impending orthopedic intervention
Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable/evaluable disease
Must be able to undergo MRI and have at least one measurable intracranial lesion for which specific criteria have to be met.
Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable IT injection.
Must have measurable disease (RECIST v1.1) in at least one lesion not previously irradiated unless documented evidence of progression
At least 1 measurable lesion per RECIST v1.1; subjects whose only measurable lesion is a lymph node will be excluded
Lytic lesion requiring an impending orthopedic intervention
Patient has at least one measurable and/or non-measurable lesion as per RANO criteria
At least 1 osteolytic bone lesion
at least one cutaneous lesion (each lesion ? 10 mm in longest diameter or up to 5 lesions having a sum of longest diameters ? 10 mm); and/or
at least one subcutaneous lesion (each lesion ? 10 mm in longest diameter by CT);
At least 1 lesion with measurable disease at baseline
Patients must have at least one measurable PN, defined as a lesion of at least 3 cm measured in one dimension; patients who underwent surgery for resection of a PN are eligible provided the PN was incompletely resected and is measurable
At least one unidimensionally measurable lesion meeting RECIST v1.1 criteria
Dose escalation: Patients with metastatic melanoma with measurable, stage III (in transit lesions) or stage IVA, IVB or IVC disease (at least 2 measurable lesions/tumors; patients will be required to have one more lesion resent than the number the current dose level requires since one lesion will be left untreated
Measurable metastatic melanoma with at least one lesion that is resectable for TIL generation, plus one other lesion that can be measured
Has measurable disease (or evaluable if not in MTD expansion cohort) via computed tomography (CT) or magnetic resonance imaging (MRI) scans with or without non-measurable tumors (a lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of that lesion prior to enrollment)
Diagnosed with DCIS, LCIS, ADH, or ALH (the most recent, highest risk lesion is the “index lesion”) between January 1, 2012 and September 30, 2016
Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
Patient whose bone-lesion interface is < 10-mm from the skin
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Palpable lesions that are not measurable by radiographic or photographic evaluations may not be utilized as the only measurable lesion. Any measurable lesion biopsied at Screening cannot be followed as a target/index lesion unless agreed upon by GlaxoSmithKline (GSK).
Groups 1, 2 and 3: At least 1 measurable lesion defined by mRECIST 1.1 for patients with GIST.
?1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 that has not been previously treated with locoregional therapy. A participant with a lesion(s) that has previously been treated with locoregional therapy is also eligible, if the lesion has documented progression after locoregional treatment and is measureable.
Radiologic evidence of at least 1 measurable lytic lesion in the arm, pelvis or leg
Measurable disease – minimum lesion size of 8 x 3 mm before initial biopsy
Progressive enhancement (> 25% increase in contrast enhancing volume compared to nadir or a new measurable lesion) on MRI performed within 28 days of registration, and >= 42 days since completion of standard radiation/temozolomide therapy; measurable enhancement is defined as two perpendicular in-plane diameters of at least 10 mm, and at least 10 mm in the 3rd orthogonal direction
A BIRADS 5 lesion
Participants must have measurable brain disease, defined as at least one lesion that is 10 mm in diameter
No chemotherapy for at least 4 weeks and no radiation to the index lesion or clear progression in that lesion (greater than 20% increase in longest diameter)
Has undergone an invasive procedure on kidney lesion (e.g. tissue biopsy, surgery, nonsurgical cytoreductive procedure) since identification of lesion via US without contrast
Patient must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by radiological evaluation (ultrasound, mammography, magnetic resonance imaging [MRI], computed tomography [CT], PET) or physical examination\r\n* Patients with evaluable osseous metastasis that are lytic or mixed lytic-sclerotic are eligible\r\n* Patients with hepatic lesions may be eligible provided the location of the lesion is peripheral or not too close to hepatic duct; decision on hepatic lesion eligibility will be made by the principal investigator or sub-investigator after careful review of all available imaging to ensure evaluation of the lesion will not be obscured by normal hepatobiliary excretion of 18F-FFNP
Patients with a lesion < 2 mm
Patient has at least 1 focal lesion in liver
New or increased enhancing brain lesion(s) OR nonenhancing brain lesion(s) if receiving anti-angiogenic therapy, which is considered indeterminate for tumor progression versus (vs) radiation injury by the neuroradiologist or clinician
Subjects with premalignant lesion, or potentially premalignant lesion, of the oral cavity mucosa (leukoplakia or erythroplakia)
Subject has oral lesion
Male or female patients with metastatic non- hematological solid tumors, with one or more brain metastases, of which at least one lesion has a diameter ?1.5 cm, as confirmed by anatomical imaging (GBCA-enhanced MRI), wherein this lesion (or lesions) is scheduled to be treated by SRS.
Subjects with at least 1 lesion of tumor of the breast
Patients with a solid lung lesion 1.5-5cm identified on chest computed tomography (CT) (obtained within previous 3 months) with the intention to undergo bronchoscopic evaluation; if the lesion is partially solid (i.e. there is a ground glass component) then the solid portion must make up > 75% of the lesion and measure at 1.5-5cm; the decision to pursue biopsy will be made by the treating physician and agreed upon by the patient; this will include patients determined to have an intermediate risk of malignancy (5-65%) and those non-surgical candidate with higher risk lesions in need of diagnosis for alternative treatment; OR
Patients with a solid lung lesion 1.5-5cm identified on chest CT (obtained within previous 3 months) that are surgical candidates with a high probability of cancer (> 65%) will be referred for surgical evaluation; if the lesion is partially solid (i.e. there is a ground glass component) then the solid portion must make up > 75% of the lesion and measure at 1.5-5cm; if the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study; all sites will use the same online calculator to document probability of malignancy
Patients currently receiving trastuzumab therapy with or without other types of systemic therapy can participate if their disease progresses (development of new lesion[s] or worsening of known lesion(s) based on imaging modalities or physical examination
At least 1 measurable lesion on CT or MRI
Lesion accessible for size measurement and photography.
Subject presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted BBB (e.g., primary and secondary tumors, focal inflammatory or demyelinating disorders) including at least one expected enhancing lesion of minimum 5 mm (long axis). This lesion must have been detected on a previous imaging procedure (computerized Tomography (CT) or MRI).
Have a lesion or biopsy marker that is visible under ultrasound
Have a lesion in which the center/focal area is defined
Hepatic lesion: The lesion can be accurately measured in at least one dimension as ?1.0 cm
The lesion is suitable for repeat measurement
Nonhepatic lesion
At least one lesion with measurable disease at baseline
Measurable disease as per modified RECIST 1.1 • A lesion in an area that was previously treated with local therapy (e.g. radiation, surgery, or cryotherapy) can be considered measurable disease as long as there is objective evidence of progression of the lesion prior to randomization
At least one measurable lesion
Cohort 1 (NSCLC cohort) \r\n* Ability to undergo a fresh tumor biopsy for the purpose of screening for this clinical trial (including able and willing to give valid written consent) to ability or to provide an available archival tumor sample taken less than 3 months prior to study enrollment (and not obtained prior to progression on a PD-1/PD-L1 inhibitor) if a fresh tumor biopsy is not feasible with an acceptable clinical risk; tumor lesions used for fresh biopsies should be the same lesions to be irradiated when possible and should not be the same lesions used as Response Evaluation Criteria in Solid Tumors (RECIST) target lesions, unless there are no other lesions accessible; additional, optional archival tumor tissue is also requested from before the prior PD-1 directed therapy
Cohort 2 (colorectal cohort) \r\n* Ability to undergo a fresh tumor biopsy for the purpose of screening for this clinical trial (including able and willing to give valid written consent) to ability or to provide an available archival tumor sample taken less than 3 months prior to study enrollment if a fresh tumor biopsy is not feasible with an acceptable clinical risk; tumor lesions used for fresh biopsies should be the same lesions to be irradiated when possible and should not be the same lesions used as RECIST target lesions, unless there are no other lesions accessible \r\n* Microsatellite stable (MSS) tumor as documented by either: \r\n** Immunohistochemistry (IHC) testing that does not suggest loss of MLH-1, MSH-2, PMS2 or MSH6 \r\n** Polymerase chain reaction (PCR) testing that does not suggest microsatellite instability (MSI)
Patients with ? 3 visceral metastases (excluding pulmonary lesions), with no lesions >3.0 cm. Patients with substantial tumor burden of non-measurable disease may not be good candidates for an immunotherapy and should be discussed with the Medical Monitor.
Injected lesions (up to two) must be between 20 mm and 90 mm in diameter for IT injection; lesions must be accessible for baseline and on-treatment biopsies.
Have at least 1 site of disease measurable by RECIST v1.1 that has not been treated with local therapy within 6 months of study treatment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Indication A only: at least 2 measurable lesions as defined per modified RECIST 1.1 within 28 days prior to the first dose of AMG 757
Participants with brainstem lesions
Lesions suspected to be at higher-risk for bleeding such as bowel involvement with tumor that invades into the bowel wall or involves the intraluminal component of bowel by imaging or direct visualization or central pulmonary lesions
Ulcerated skin lesions
Patients with untreated brainstem metastases are eligible if lesions are small and asymptomatic
Measurable Disease Progression: >20% increase in the sum of diameters of measurable lesions from the time of maximal regression or appearance of one or more new lesions.
Pulmonary metastases found at relapse (does not have to be first relapse); no more than 3 lesions per hemi-thorax will be treated but other lesions in the lung may be present
Patients with multiple lesions will be eligible as long as there are no overlapping fields of radiation, including at various time frames
Patients whose disease has progressed following at least 3 cycles of neoadjuvant chemotherapy as defined by at least one of the following:\r\n* Doubling of serum CA-125 level\r\n* At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions\r\n* Clinical deterioration (worsening ascites, carcinomatous ileus, malignant bowel obstruction, severe hypoalbuminemia, declining performance status)
Patients are stage IV (M1) with any combination of T and N with oligometastatic disease as defined by 5 or fewer total sites of metastatic disease involving 3 or fewer organ systems\r\n* Examples of patients eligible for trial\r\n** T3N2M1 non-small cell lung cancer (NSCLC) with 1 central nervous system (CNS) metastatic lesion, 2 liver lesions, and 1 adrenal lesion.\r\n** T4N1M1 colorectal cancer with 1 liver lesion, 4 bone lesions \r\n** T3N0M1 gastric cancer with 1 supraclavicular lymph node, 2 liver lesions, and 2 CNS lesions
Patients with other fibroblastic lesions or other fibromatoses are NOT eligible.
Radiation to all target lesions within 12 weeks of study baseline,
No measurable target lesions.
Presence of metastatic disease that would be amenable to the required biopsies; ideally pre and post biopsies should be from the same lesion and otherwise from lesions in the same organ; if not possible, then biopsy of the lesions in different organs will be permitted
? 3 lesions in the liver
Active oral or genital herpes lesions
Participant must be a candidate for palliative radiation treatment to at least one bone, lymph node, or soft tissue lesion; radiation of visceral lesions (such as lung or hepatic lesions) is not permitted
Participants with bone lesions requiring surgical fixation to provide mechanical stability are ineligible; participants with previously fixed lesions are allowed
MK-1454 (cut/subcut lesions) and MK-1454+pembro (cut/subcut lesions) Arms:
Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass > 1.5 cm is acceptable; lesions that are considered non-measurable include the following:\r\n* Bone lesions (lesions if present should be noted)\r\n* Ascites\r\n* Pleural/pericardial effusion\r\n* Lymphangitis cutis/pulmonis\r\n* Bone marrow (involvement by lymphoma should be noted)
The presence of 3 or more MR Visible lesions positive on biopsy.
Radiotherapy delivered to non-target lesions within one week prior to starting study treatment or delivered to target lesions that will be followed on the study (note: prior sites of radiation will be recorded).
Subjects with CNS lesions are excluded
Radiotherapy: at least 3 weeks since most recent radiotherapy; prior radiated lesions will not be evaluable unless there is documented progression post therapy; palliative radiotherapy to localized painful lesions is acceptable when the patient is on study: at least one week after completion of radiation therapy (RT) and recovery from associated toxicities before restarting ARQ 761; irradiated lesions will not be evaluable for response
The PN must be inoperable, defined as a PN that cannot be surgically completely removed without risk for substantial morbidity due to: encasement of or close proximity to vital structures, invasiveness, or high vascularity of the PN; the PN either causes morbidity or it is growing and has the potential to cause morbidity such as (but not limited to): head and neck lesions that could compromise the airway or great vessels, paraspinal lesions that can cause myelopathy, brachial or lumbar plexus lesions that could cause nerve compression and loss of function, lesions that could result in major deformity (e.g., orbital lesions) or are significantly disfiguring, and lesions of the extremity that cause limb hypertrophy or loss of function or pain; PN growth will be defined as a >= 20% increase in PN volume within approximately 3 years prior to enrollment on this trial
Patients with high-grade cervical intraepithelial lesions (CIN2/3) confirmed by colposcopy and biopsy
Presence of brainstem lesions or lesions that are less than 5 mm from the hypophysis or cranial nerves
Patients with multifocal tumors must have resectable lesions
Structurally unstable bone lesions suggesting impending fracture
Patients who have received prior radiation of osseous lesions
Two or more bone lesions
Have a target lesion/s deemed suitable by the treating physicians for stereotactic body radiation therapy (SBRT) with the intent of palliation or prevention of symptoms; this lesion must be: a) 1-3 non overlapping sites in the H&N region OR  b) metastatic lesions outside the head and neck (H&N) region in the lung or bone (a minimum of 1 and a maximum 5 lesions will be irradiated), provided there is no significant overlap between the lesions; patients should have RECIST 1.1 criteria measurable disease in addition to the lesion/s treated with SBRT; if the site/s of SBRT were previously radiated to > 50Gy, there should be > 6 month time interval between the last dose of radiation and the start of SBRT
Have evaluable disease; lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Patients will be excluded from randomization if they meet any of the following criteria:\r\n* Any of the exclusion criteria; \r\n* Complete response to osimertinib or prior treatment to all visible lesions, such that no lesion is amenable to LCT. Note that patients can receive palliative radiation therapy prior to randomization to CNS lesions or those requiring urgent treatment (e.g. for pain or bleeding), but are only eligible for the study if they have one site amenable to further radiation therapy. In addition, these lesions will be counted towards the total number of metastases, and will also be counted as target lesions
Lesions of any surface span as long as =< 1 cm in maximal height measured from the skin surface for which local control is desired are eligible; a single patient may have multiple eligible lesions that are individually enrolled for the study.
Lesions with a height > 1 cm measured from the skin surface are not eligible for this protocol.
Have measurable disease based on RECIST 1.1 as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Subjects must have a minimum of three (3) evaluable, discrete lesions.
Anal HSIL lesions are visible at randomization and no lesions are suspicious for invasive cancer
Patients requiring palliative radiotherapy to lesions that are defined as target lesions by RECIST criteria at the time of study entry.
Up to 4 metastatic lesions: \r\n* Must have at least 1 bone lesion AND each non-visceral lesion should be less than 5 cm\r\n* Visceral lesions will be limited to one lung lesion (< 2 cm); no liver lesions allowed
Two lesions can be in close proximity (i.e. within 5 cm of each other) if they meet radiation SBRT normal tissue toxicity requirements
Structurally unstable bone lesions suggesting impending fracture
Minimum of 3 radiographically apparent lesions such that there is:\r\n* Minimum of one lesion in areas that have not been previously irradiated that is considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria AND\r\n* Minimum of two lesions in areas that have not been previously irradiated that are determined by interventional radiology to be of a size and in a location that a single probe could ablate at least 75% of the lesion; Note: Hepatic lesions measuring =< 3 cm may be treated, as determined by interventional radiology; Note: Brain metastases are not acceptable as lesions defining measurable disease, nor are they candidate lesions for cryoablation
Have measurable disease based on RECIST 1.1 as determined by the investigator/radiology assessment; target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Presence of a candidate treatment lesion (subcutaneous or nodal lesions are preferable but visceral lesions will be considered) accessible and safe for radiotherapy and serial intralesional injections
Patients must have evaluable disease by clinical exam (i.e. palpable lymphadenopathy, measurable skin lesions, etc.), laboratory assessment (i.e. lymphoma involvement of bone marrow or peripheral blood by morphology, cytology or flow cytometry), and/or imaging (measurable lymph nodes or masses on computed tomography [CT] or magnetic resonance imaging [MRI] and/or evaluable fludeoxyglucose [FDG]-avid lesions on positron emission tomography [PET])\r\n* NOTE: lesions that have been irradiated cannot be included in the tumor assessment unless unequivocal tumor progression has been documented in these lesions after radiation therapy
For Arms A-F, subjects must have biopsiable disease. For Arms A, B, and C, subjects must have at least two lesions amenable to biopsy and response evaluation. For Arms D, E, and F, subjects must have at least three lesions amenable to biopsy, response evaluation, and radiation. Tumor lesions used for biopsy should not be lesions used as RECIST target lesions.
Pathological or clinical (i.e., by imaging) diagnosis of brain metastatic tumor lesions
Total volume of lesions =< 30 cm^3
Presence of unreachable (e.g. located in a region that cannot be reached by needle) or untreatable tumor lesions so that the benefit from the treatment of the treatable lesions does not justify patient's inclusion
Subjects must have at least 1 injectable cutaneous, subcutaneous soft tissue or nodal lesion >= 10 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
Patient must have at least 3 measurable lesions that are >= 1.5 cm in one dimension; one of the lesions must be >= 2.0 cm and is amenable to image-guided cryoablation and multiple vaccine injections as determined by interventional radiology and principal investigator (PI) (including tumors that can be safely accessed using imaging guidance and treated with minimal risk to adjacent structures)
Patients must have measurable or non-measurable disease\r\n* Measurable disease\r\n** For visceral or extra-nodal lesions to be considered measurable, they must be >= 10 mm in one dimension, using spiral computed tomography (CT)\r\n** For lymph nodes to be considered measureable (i.e., target or evaluable lesions), they must be >= 20 mm in at least one dimension, using spiral CT\r\n* Non-measurable disease\r\n** All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions.\r\n*** Lesions that are considered non-measurable include bone lesions (only)
Soft tissue disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study); in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm; (Note: the appearance of one or more new non-osseous lesions is also considered progression); clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules, palpable lymph nodes) and at least 10 mm in diameter as assessed using calipers (e.g., skin nodules)\r\n* Per Prostate Cancer Working Group 2 (PCWG2): Visceral (lung, liver adrenal) or extranodal lesions need to be >= 10 mm in one dimension, using spiral CT; however, lymph nodes need to be >= 20 mm in at least one dimension to be considered new
No structurally unstable bone lesions suggesting impending fracture
Radiation within 6 weeks of leukapheresis. Subjects must have progressive disease in irradiated lesions or have additional non-irradiated, PET-positive lesions to be eligible. Radiation to a single lesion, if additional non-irradiated PET-positive lesions are present, is allowed up to 2 weeks prior to leukapheresis.
Subjects must have plexiform neurofibroma(s) that are progressive OR are causing significant morbidity, such as (but not limited to) head and neck lesions that are compromising the airway or great vessels, brachial or lumbar plexus lesions that are causing nerve compression and loss of function, lesions causing major deformity (e.g., orbital lesions) or are significantly disfiguring, lesions of the extremity that cause limb hypertrophy or loss of function, and painful lesions; patients with paraspinal plexiform neurofibromas will be eligible for this trial; histologic confirmation of tumor is not necessary in the presence of consistent clinical and radiographic findings, but should be considered if malignant degeneration of a plexiform neurofibroma is clinically suspected
No more than 10 lesions in the liver
Any radiation to the target lesions within 6 months of enrollment
Target lesions greater than 10 cm
Have measurable disease based on RECIST 1.1 as confirmed by the blinded MD Anderson radiology; target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions; Note: the same image acquisition and processing parameters should be used throughout the study for a given subject
Patient must have at least one measurable untreated lesion as per modified RECIST criteria; measurable disease may include extrahepatic lesions; abdominal imaging should employ a “liver protocol” image capture technique; the following are not considered measurable lesions: bone lesions, ascites, and pleural effusions; prior radiofrequency ablation (RFA), percutaneous ethanol injection (PEI), or transarterial chemoembolization (TACE) of non-target lesions is allowed
Subjects with PE lesions only in the sub-segmental or smaller arteries;
Have measurable disease based on RECIST 1.1; target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Target lesions that have previously received radiation must have shown radiographic progression following radiation or must have other non-radiated lesions present
=< 3 liver lesions
Willingness to provide consent for biopsy samples; tumor biopsies will be required for all subjects, tumor lesions used for biopsy should not be lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy; if a RECIST target lesion is used for biopsy the lesion must be >= 2 cm in longest diameter
Patients must have substantial cutaneous neurofibroma burden causing distress to the patient by disfigurement or itching; patients must have >= 9 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 >= 4 mm in the longest diameter
Patients must have multiple tumor lesions (at least 2): one for the ablation procedure and another for evaluation located outside the proposal ablation zone
Five or more metastatic brain lesions
3 or fewer brain metastases; Note: if lesions are symptomatic or greater than or equal to 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible
Have measurable disease based on RECIST 1.1; only cohort 9 and 10 can have evaluable disease (non-measureable lesions); tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions; patients may have bone metastatic disease evaluable according to tumor evaluation criteria best suitable and accepted for the tumor type evaluated
Have biopsiable disease; subjects must have at least one lesion amenable to biopsy; tumor lesions used for biopsy should not be lesions used as RECIST target lesions; in cohort 9: paraganglioma-pheochromocytoma or cohort 10, where there is prominent bony disease, biopsies may not be possible due to the nature of the disease
Lesions located outside of the spinal segments of T2 to T12
Have at least one site of metastatic disease amenable to radiation; all lesions amenable to radiation may be irradiated at the discretion of treating radiation oncologist, depending on the location, size and number of lesions
Patients receiving any other investigational agents for any reason or non-investigational agents administered for the purpose of controlling cancer growth (use of conventional external beam radiation therapy will be allowed during protocol therapy solely for palliation of localized painful lesions or bone lesions at risk of fracture provided the radiation field does not encompass any selected target lesions required for assessment)
Patients may have either metastatic lesions from another primary site or primary hepatocellular carcinoma; patients with one histologically confirmed metastatic lesion of the liver who are presenting for local therapy for lesions concerning for metastases that cannot or should not be biopsied will also be considered for enrollment on a case by case basis; patients can simultaneously receive treatment for multiple hepatic lesions meeting the prior two requirements, at the discretion of the treating radiation oncologist
Disease that is measurable; this is defined as lesions measuring at least 10 mm on radiologic imaging; for lymph node disease, the lesion must measure at least 15 mm or have been biopsied and shown to contain melanoma; skin or mucosal lesions that are not measurable on radiologic imaging but measure at least 5 mm on clinical exam are also acceptable
Patients must have pathologic diagnosis of adenocarcinoma or large cell carcinoma of the lung with confirmation by immunohistochemistry (e.g., transcription termination factor 1 [TTF-1] positivity) (histologic tissue diagnosis is recommended, but cytology is acceptable); stage IIIA/IIIB or oligometastatic stage IV in which the patient is still considered an appropriate candidate for aggressive chemoradiotherapy for the primary tumor; oligometastatic disease is defined as =< 5 metastatic sites (=< 3 lesions per organ); for intracranial metastasis, the patient should have asymptomatic disease that is stable on steroids or 1 to 3 symptomatic metastatic lesions treated with stereotactic radiosurgery (SRS)
Lesions that are accessible for injection and electroporation, defined as cutaneous or subcutaneous disease.
PHASE II: Presence of at least one measurable CNS target lesion for which the following criteria are met:\r\n* At least 5 mm in size (Note: intra-cranial disease assessments can only be performed using contrast-enhanced magnetic resonance imaging [MRI]; MRI scan slices of 1 mm are necessary for brain metastases between 5 and 10 mm in size)\r\n* Lesions must be untreated or progressive according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (>= 20% 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 2 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 1.1 (> 20% increase in longest diameter on baseline scan) or new measurable lesions are required
The additional lesions will each be treated with stereotactic radiosurgery
All metastatic lesions must be separated by a minimum of 3 cm as measured from the peripheral edges of the lesions which are in closest proximity to one another; if multiple lesions are present and are not all >= 3 cm away from each other, the patient will be deemed ineligible
Brain lesions with an equivalent diameter of > 40 mm in size on MRI imaging at the time of consultation/screening for protocol eligibility
Recurrent lesions with dimension and contour that are determined by the treating neurosurgeon to be appropriate for MLA
Patients must have non-measurable disease (such as nuclear medicine bone scans) and non-target lesions (such as PSA level) assessed within 28 days prior to initial administration of drug
Patients with intradural or intramedullary lesions, or lesions with < 2 mm distance from tumor to spinal cord
Patients with a history of complete surgical resection of CNS lesions are eligible if there is no evidence of CNS lesions (MRI or CT required) at study entry evaluation and if other entry criteria are met
Radiation within 4 weeks of study enrollment; radiotherapy not permitted while on study; exception: palliative radiotherapy of metastasis in extremities is allowed, but such lesions cannot be used as target or non-target lesions
Patients presenting with lesions that may harbor an occult infectious source
The additional lesions will each be treated with single fraction stereotactic radiosurgery
Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
Lesions not amenable to GTR
Patients will be excluded if they have < 4 lesions, or > 15 lesions at enrollment or > 20 lesions at the time of treatment (note: patients who qualify for enrollment based on having 4-15 lesions, but who are discovered to have up to 20 lesions on the volumetric MRI used for treatment planning will be allowed to continue on study)
Dermatology evaluation with excision of any suspicious lesions prior to initiation of therapy
patients with high grade cervical intraepithelial lesions (CIN2/3)
2. Stage II-IV disease; T 2-4, N any, M0. Measurable disease is required with the following criteria: Measurable lesions can be accurately measured, with at least one diameter >\\= 1.0 cm by spiral CT scan or MRI. Lesions can be bidimensionally measurable or unidimensionally measurable. Every effort should be made to measure lesions in two dimensions. Measurable disease is present if the patient has one or more measurable lesions. Non-measurable lesions/disease are all other lesions, including small lesions (those with measurements < 2.0 cm; or < 1.0 cm with spiral CT).
Presence of any oral lesions that may confound the ability to assess oral mucositis grade
Patients must be eligible to have all lesions treated as determined by the study radiation oncologist.
Bone lesions: lytic lesions, severe osteopenia or pathologic fractures
presence of 3 brain lesions or less
One to 3 painful lesions.
More than 3 painful lesions or more than 2 requiring immediate localized treatment
Presence of ulcerating or fungal skin lesions or infection of the breasts
Concurrent vaginal, vulvar, anal lesions or symptomatic infections
Measurable disease, according to RECIST v1.1. Note that lesions intended to be biopsied should not be target lesions
Non-measurable lesions include the following: small lesions (longest diameter < 1.0 cm for all lesions other than pathologic lymph nodes, which are >= 1.0 cm and < 1.5 cm in the short axis), bone metastases, pleural effusions, pericardial effusions, ascites, inflammatory breast disease, leptomeningeal disease, lymphangitis pulmonis, lymphangitis cutis, and abdominal masses not followed by CT or magnetic resonance imaging (MRI)
Structurally unstable bone lesions suggesting impending fracture
Phase II: inoperable PN causing morbidity, such as (but not limited to) head and neck lesions that could compromise the airway or great vessels, brachial or lumbar plexus lesions that could cause nerve compression and loss of function, lesions that could result in major deformity (e.g., orbital lesions) or significant cosmetic problems, lesions of the extremity that cause limb hypertrophy or loss of function, and painful lesions in patients with NF1; histologic confirmation of PN tumor is not necessary in the presence of consistent clinical and radiographic findings, but should be considered if malignant degeneration of a PN is clinically suspected; a PN is defined as a neurofibroma that has grown along the length of a nerve and may involve multiple fascicles and branches; a spinal PN involves two or more levels with connection between the levels or extending laterally along the nerve; in addition to PN, all study subjects must have either positive genetic testing for NF1 confirmed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory or have at least one other diagnostic criterion for NF1 listed below (National Institutes of Health [NIH] Consensus conference):\r\n* Six or more café-au-lait macules (>= 0.5 cm in prepubertal subjects or >= 1.5 cm in post pubertal subjects)\r\n* Freckling in axilla or groin\r\n* Optic glioma\r\n* Two or more Lisch nodules\r\n* A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)\r\n* A first-degree relative with NF1
Lesions suspected to be at higher-risk for bleeding such as bowel involvement with tumor that invades into the bowel wall or involves the intraluminal component of bowel by imaging or direct visualization or central pulmonary lesions
Ulcerated skin lesions
No prior radiation to lesions being treated
Have measurable disease based on RECIST 1.1., or detectable disease; lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Soft tissue lesions >= 1.0 cm in longest axis\r\n* Soft tissue lesions < 1.0 cm that have been stable for > 6 months (must not have enlarged > 5 mm) are permitted
Patients must have no evidence of metastatic disease; metastatic disease:\r\n* Are lesions which are discontinuous from the primary tumor, are not regional lymph nodes and do not share a body cavity with the primary tumor; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be taken\r\n* Skeletal lesions in adjacent bones (trans-articular)\r\n* Contralateral pleural effusion and contralateral pleural nodules\r\n* Distant lymph node involvement\r\n* Patients with pulmonary nodules are considered to have metastatic disease if the patient has:\r\n** Solitary nodule > 0.5 cm or multiple nodules of > 0.3 cm unless biopsied and negative for Ewing's\r\n** Biopsies of solitary nodule =< 0.5 cm or multiple nodules =< 0.3 cm are not required but if performed and positive indicate metastatic disease
Subjects who have received radiotherapy to tumor lesions that would be chosen as target lesions (measurable disease) within 4 weeks before the start of treatment, except if there is objective evidence of progression of the lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the prior radiotherapy and the screening CT or magnetic resonance imaging (MRI) scan; palliative radiotherapy to non-target lesions is allowed at the investigator’s discretion
Patients having no distinct measurable lesions outside of the field of radiation
Previous treatment of the target lesions with radiation therapy
Patients must have baseline skeletal survey to document lytic lesions, osteopenia or compression fracture within 28 days prior to registration
Participants must have measurable melanoma; measurable disease is defined as at least one lesion that can be measured accurately in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan; cutaneous or subcutaneous lesions may be considered measurable if they can be measured reliably as >= 10 mm by direct physical exam measurement; in addition, participants must also have separate disease, which may or may not be measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST), but must be readily accessible for core needle biopsy, excisional biopsy, and/or surgical resection; this disease may include one large tumor tissue deposit from which biopsies can be harvested multiple times or may include multiple deposits which can be biopsied, or excised individually, on different dates; please see below for suggested minimum size requirements of tumor tissue to be used for biopsy for research:\r\n* 1 lesion >= 5 cm^3 or\r\n* 2 lesions >= 3 cm^3 each\r\n* 3 lesions >= 2 cm^3each OR\r\n* >= 3 skin lesions, such that the surface area is approximately 1 cm^2 each (or in aggregate for several lesions) and the total volume of tumor is approximately 260-325 mm^3 or greater for each biopsy time point; these subjects will need >= 3 such epidermal/dermal tumor lesions; excisional tumor tissue biopsies will be performed on one or more lesions at each time point; it is acceptable to biopsy more than one lesion, that may be less than 1 cm^2 in surface area, as long as the total tissue removed has a surface area of approximately 1 cm^2 or greater\r\n* A combination of these may be acceptable, as long as there appears to be enough tumor tissue to remove approximately 325 mm^3 or more of tissue at each time point
One to ten brain metastatic lesions
Has evaluable disease as defined as lesions that can be accurately measured at least in one dimension by radiographic examination or physical examination and other lesions such as bone lesions, leptomeningeal disease, ascites, hepatosplenomegaly from disease.
Brain lesions >3 lesions which were previously treated with SRT
Patients must have no lytic lesions on skeletal surveys and no hypercalcemia (i.e., >= 11 mg/dL)
Patients must not have baseline bone lesions or plasmacytomas
Lung tumor lesions with increased likelihood of bleeding;
Tumor biopsies are required. If a subject has inaccessible lesions, such as in ovarian cancer, HCC, or gastric cancer, or highly vascular lesions, such as RCC, enrollment may be considered with medical monitor approval, and archived tissue may be acceptable.
Participants with paraspinal, paratracheal and mediastinal pathologic lesions larger than 2 centimeters unless they are previously irradiated
Bone lesions
Patients must have completed any prior chemotherapy, radiotherapy or major surgery at least 4 weeks before receiving study treatment; ongoing toxicities related to treatment must be =< grade 1 and patients with grade 2 alopecia or peripheral neuropathy can also be included; palliative radiation to < 10% of bone marrow is permissible if completed within one week of commencing study treatment as long as the toxicities secondary to palliative radiotherapy are limited to grade 1; the lesions that have received radiation treatment immediately before will be excluded as target lesions; previously irradiated lesions can be considered as targeted lesions, as long as there is prove of radiological progression
Unidimensionally measurable disease; indicator lesions must not have been irradiated unless they have grown following radiation therapy
Concurrent anticancer treatment (for example, cytoreductive therapy, radiotherapy [with the exception of palliative bone-directed radiotherapy, or radiotherapy administered on non-target superficial lesions], immune therapy, or cytokine therapy except for erythropoietin). Radiotherapy administered to superficial lesions is not allowed if such lesions are considered target lesions in the efficacy evaluation or may influence the efficacy evaluation of the investigational agent
Subjects must have measurable lesions (at least one target lesion measuring 2 cm in diameter) by computerized tomography (CT) scan, and/or measurable lymphoma cutaneous lesions of any size
Have measurable disease (? 1 measurable lesion) based on RECIST v1.1 as determined by the site study team. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Measurable disease by RECIST 1.1 criteria. Target lesions selected for tumor measurements should be those where surgical resection or radiation are not indicated or anticipated.
A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy.
Soft-tissue progression defined as an increase ? 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
Soft-tissue progression defined as an increase ? 20% in the sum of the diameter (SOD; short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD, or the appearance of one or more new lesions, since the onset of the most recent prior therapy
Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass > 1 cm is acceptable; lesions that are considered non-measurable include the following:\r\n* Bone lesions (lesions if present should be noted)\r\n* Ascites\r\n* Pleural/pericardial effusion\r\n* Lymphangitis cutis/pulmonis\r\n* Bone marrow (involvement by SLL or CLL should be noted)
Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease as defined above.
Patients must have baseline skeletal survey (whole body x-ray) to document lytic lesions, osteopenia or compression fracture
have at least 1 measurable lesion assessable by radiological imaging. Tumor lesions located in a previously irradiated area are considered measureable if progression has been demonstrated in such lesions
Previous use of systemic chemotherapy or other investigational drugs for the treatment of inoperable locally recurrent or metastatic tumors (previous use of radiotherapy or chemotherapy in this setting is not an exclusion criterion if: 1) non-irradiated target tumor lesions are present at randomization for the purpose of tumor response assessment or 2) in the absence of non-irradiated target tumor lesions, progression of the irradiated tumor lesions according to the RECIST criteria version 1.1 is documented)
Presence of at least 2 measurable lesions
Patients with histologically documented metastatic melanoma with at least 3 cutaneous lesions measuring over 5 mm diameter; at least two lesions must be at least 10 mm in diameter to serve as the injected disease; at least one other lesion measuring at least 5 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 M1A disease with cutaneous or nodal lesions assessable for administration of LL37; patients are only eligible if their melanoma deposits are not amenable to complete surgical excision; skin lesions that are 5 mm or greater are deemed measurable however lesions that are at least 10 mm in diameter will be preferentially utilized for LL37 injection
Patients may receive bisphosphonates; however, if used, bone lesions may not be used for progression or response
Patients must have brain imaging by MRI, CT or PET within 30 days prior to lymphodepletion; patients may have asymptomatic brain lesions that are =< 1 cm each, lesions that are > 1 cm that have been irradiated and in the opinion of the investigator no longer represents active disease will also be allowed
Prostate with multiple cystic lesions.
To differentiate T3 lesions involving the mediastinal pleura from T4 lesions involving major vessels or organs, a chest magnetic resonance imaging (MRI) will be obtained; if any uncertainty remains, the patient will have four-dimensional computed tomography (CT) scans (4DCT) in an effort to determine the degree of tumor motion; a freely mobile tumor during ventilation will be judged to be T3 disease
Repeat palliative RT will be permitted for the treatment of isolated, non-target lesions
Lesions that have been radiated previously cannot be considered target lesions
Concurrent radiotherapy is not permitted for disease progression on treatment on protocol; however, symptomatic treatment for pre-existing non-target lesions would be allowed with approval from the principal investigator
Note: Biopsied lesions should not be used as target lesions.
Note: Biopsied lesions should not be used as target lesions.
Patient has 1-3 major painful osseous metastases (target lesions); these do not require biopsy if they are radiographically consistent with osseous metastases; the target lesions may be from any primary cancer or unknown primary cancer, including multiple myeloma
Long bone target lesions with a Mirels fracture score > 7
Subjects must have plexiform neurofibroma(s) that are progressive OR are causing significant morbidity, such as (but not limited to) head and neck lesions that are compromising the airway or great vessels, brachial or lumbar plexus lesions that are causing nerve compression and loss of function, lesions causing major deformity (e.g., orbital lesions) or are significantly disfiguring, lesions of the extremity that cause limb hypertrophy or loss of function, and painful lesions; subjects with paraspinal plexiform neurofibromas will be eligible for this trial; histologic confirmation of tumor is not necessary in the presence of consistent clinical and radiographic findings, but should be considered if malignant degeneration of a plexiform neurofibroma is clinically suspected
Have at least 1 measurable lesion per RECIST v1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were: 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection.
Patients with more than 6 discrete extra-cranial lesions
No more than 5 lesions
Concurrent radiotherapy is not permitted for disease progression on treatment on protocol, but might be allowed for pre-existing non-target lesions with approval from the principal investigator of the trial
At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by computed tomography (CT) scan or magnetic resonance imaging (MRI), as defined by the Lugano Classification\r\n* Site of disease deemed amenable to low-dose, local radiotherapy (2 x 2Gy) should not be counted as target lesions\r\n* Previously irradiated lesions should not be counted as target lesions\r\n* Lesions that are intended to be used to collect tissue samples for biopsy should not be counted as target lesions\r\n* Bone lesions should not be counted as target lesions
Patients have progressive metastatic disease with predominantly bone metastasis with 1 or more lesions and at least 1 bone lesion has pathological confirmation, have not been treated or have been treated with any prior therapies (including bisphosphonate treatment and/or radiation therapy); patients can have soft tissue involvement (lymph node and skin) and/or metastatic lesions at major organ sites (i.e. lung, liver, etc)
For visceral or extra-nodal lesions to be considered measurable, they must be >= 10 mm in one dimension, using spiral CT
All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions; lesions that are considered non-measurable include bone lesions (only)
Patients with node only disease (i.e. no presence of visceral, extra nodal lesions or bone lesions) must have node(s) that measure >= 15 mm in short axis
No structurally unstable bone lesions suggesting impending fracture
Patients must have measurable lesions
Patient with symptomatic or growing CNS metastatic lesions
Metastatic disease outside the intraperitoneal cavity and retroperitoneum, intrahepatic lesions, or pleural effusions; significant ascites precluding catheter placement; exception: intrahepatic lesions removed or planning to be removed during the debulking procedure
STEP 1 ENROLLMENT: three or less metastatic lesions (not sites); each lesion (including a satellite nodule) will individually be counted as one, and intrathoracic lymph node involvement (defined here as hilar, mediastinal, or supraclavicular nodes, N1-N3) will collectively be counted as one; in addition, patients can receive treatment to CNS lesions or other symptomatic lesions requiring urgent local therapy prior to randomization, but these lesions will be counted towards the total number after chemotherapy, and patients will only be eligible if there are remaining sites amenable to local therapy after up-front systemic therapy
STEP 2 ENROLLMENT AND RANDOMIZATION: treatment to central nervous system lesions, such as the brain or spine (prior to first line systemic therapy), or symptomatic lesions requiring urgent palliative radiation, is permitted prior to randomization, in which case the patient would be randomized to treatment of other metastatic sites or the primary sites (based on the disease remaining after first-line treatment); these treated lesions should be counted towards the total number of metastases at the time of enrollment
Patients must have disease that is refractory (unresponsive) to radioactive iodine (RAI) treatment as defined by one of the following: \r\n* One or more measurable lesions that do not demonstrate RAI uptake \r\n* One or more measurable lesions progressive by RECIST 1.1 within 12-months of prior RAI therapy and/or the appearance of one or more new lesion within 12 months of prior RAI therapy\r\n* Cumulative RAI dose of > 600 mCi\r\n* Measureable disease that is fludeoxyglucose (18F) positron emission tomography (PET) scan positive
Have measurable skin disease with 1 to 4 eligible baseline target lesions with a total area >= 25 cm^2 but =< 100 cm^2; eligible lesions must be below the neck and may not involve the genitalia, intertriginous areas, internally, or to frankly ulcerated or infected skin
Confirmed presence of somatostatin receptors on all target lesions (for target/non-target/measurable lesions definition see §Appendix 2, Section 1 and 2, RECIST Criteria, Version 1.1) documented by CT/MRI scans, based on positive OctreoScan® imaging within 24 weeks prior to randomization in the study (to be centrally confirmed). The OctreoScan® should be one that was performed while the patient was on a fixed dose of Octreotide LAR. If a patient has had an OctreoScan® performed while Octreotide LAR treatment-naïve, the patient must have a repeat OctreoScan® performed after 3 months of Octreotide LAR treatments before entering the clinical study to prove that the index lesions or new lesions still meet the criteria for inclusion. It is acceptable to have patients temporarily switched to Octreotide s.c. (up to six weeks) in order to obtain an OctreoScan®, provided they return to the same fixed dose of Octreotide LAR prior to the scan.
Non-measurable disease: all other lesions, including small lesions (less than 1.0 x 1.0 cm) and truly non-measurable lesions; lesions that are considered non-measurable include the following:\r\n* Bone lesions (lesions if present should be noted)\r\n* Ascites\r\n* Pleural/pericardial effusion\r\n* Lymphangitis cutis/pulmonis\r\n* Bone marrow (involvement by Hodgkin’s lymphoma should be noted)
Lesions must be amenable to accurate and repeat measurement.
Subjects with benign lesions such as fibroadenoma, atypical ductal hyperplasia, sclerosing adenosis, Papilloma, fibrocystic disease of breast
Subjects must have measurable or evaluable disease; disease sites that are evaluable for progression but not measurable per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 include:\r\n* Bone lesions\r\n* Previously irradiated lesions\r\n* Cutaneous manifestations (non-discrete lesions only)
Previous treatment with radiotherapy to the target lesions
All patients must be considered an eligible candidate for systemic therapy as determined by the investigator; to be eligible, LYP patients must be in need of systemic therapy i.e., have scarring or active lesions (>= 10 per month), or any number of active lesions on face, hands, or feet
At least 1 target lesion, as defined by RECIST, that has not been irradiated; new lesions that have developed in a previously irradiated field may be used as sites of measurable disease assuming all other criteria are met; all target lesions must have a unidimensional diameter of at least 1 cm for spiral computed tomography (CT) scans if the reconstruction algorithm is 0.5 cm, or a standard uptake value (SUV) >= 2.5; baseline measurements/evaluations must be completed within 4 weeks prior to treatment
Disease to be treated on protocol is less than 2 mm from the spinal cord and therefore will not meet dose constraints; Note: patients with eligible and ineligible lesions will be accrued to this protocol; only target eligible lesions will be treated per protocol; other eligible and ineligible lesions will be treated at the discretion of the treating physician
Lesions which comprise > 70% of the width of weight bearing bones, such as the femur
Areas to be treated on protocol do not include metastases to liver, brain or lung; Note: patients with eligible and ineligible lesions will be accrued to this protocol; only target eligible lesions will be treated per protocol; other eligible and ineligible lesions will be treated at the discretion of the treating physician
Patients cannot have more than 3 liver lesions
BONE LESIONS:
Other metastatic lesions not previously treated with radiation therapy are allowed providing they are measurable by CT or MRI
Untreated T1-2N0 primary lesions may also be treated with SBRT
Patients with T1, N0 lesions
CT scans showing involvement of ? 1clearly demarcated lesions measuring ? 1.5 cm
At least 2 biopsiable easily accessible cutaneous and subcutaneous lesions in patients in the metastatic disease cohort
At least one of the following indications for therapy:\r\n* Pulmonary involvement\r\n* Visceral involvement\r\n* Pain\r\n* Edema\r\n* Substantial lymph node involvement\r\n* Ulcerating lesions\r\n* Decreased range of joint motion due to KS\r\n* Multiple lesions not amenable to local therapy\r\n* Significant psychological impact leading to social withdrawal
Patients with neurofibromatosis type 1 (NF1) and an inoperable plexiform neurofibroma that has the potential to cause significant morbidity, such as (but not limited to) head and neck lesions that could compromise the airway or great vessels, brachial or lumbar plexus lesions that could cause nerve compression and loss of function, lesions that could result in major deformity (e.g., orbital lesions) or significant cosmetic problems, lesions of the extremity that cause limb hypertrophy or loss of function, and painful lesions; histologic confirmation of tumor is not required in the presence of consistent clinical and radiographic findings; however, if any clinical observation or scan suggests possible malignant transformation, the tumor should be biopsied prior to therapy; patients without biopsy-proof of a plexiform neurofibroma must have at least one other diagnostic criteria for NF1 as defined by the National Institutes of Health (NIH) Consensus Conference:\t\r\n* Six or more café-au-lait spots (> 0.5 cm in prepubertal subjects or > 1.5 cm in postpubertal subjects)\r\n* Freckling in the axilla or groin\r\n* Optic glioma\r\n* Two or more Lisch nodules\r\n* A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)\r\n* A first degree relative with NF1
Subject must have at least 1 measureable lesion based on RECIST V1.1. Previously irradiated lesions will not be considered as measurable lesions.
Subject has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1. Evaluable target lesions may not have been treated with local therapy; previously treated lesions may only be evaluated as target lesions if they are the only lesions available and have shown objective definite progression after prior treatment. Local therapy must have been completed at least four weeks prior to baseline tumor evaluation
Radiation therapy (except for localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture): ?4 weeks
Radiation therapy (localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture) ?2 weeks
Brain lesions must be 1) supratentorial, 2) ten lesions or less, and 3) not considered a candidate for surgical resection
For Phase I: Locally advanced or metastatic B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E/K positive melanoma that is either treatment-naïve or treatment-experienced; for the latter, progression, or stable as best response, or intolerance to the last treatment is required; previous treatments can be local or systemic therapies; there are no limits to the number of prior therapies; for all patients, disease does not have to be measurable but must be evaluable, which is defined as one or more lesions which are known to be present, but which cannot be measured; e.g.: bony lesions, pleural effusion, ascites
Patient must have 1 lesion with a maximum AXIAL diameter of 12 cm; up to 3 satellite lesions are permitted; satellite lesions, are defined as lesions less than 2 cm that are within 1 cm of the periphery of the dominant lesion (GTV) are permitted; the satellite lesions are NOT included in the AXIAL diameter measurement; regional lymph node involvement within the porta hepatis (as medial as superior mesenteric vein [SMV] portal vein confluence) is permitted if nodes are deemed clinically positive (i.e. fludeoxyglucose F 18 [FDG] avid)
Multiple lesions that don’t meet the criteria as satellite lesions
Participants must have cutaneous lesion(s) amenable to four total biopsies (either four lesions > 4 mm or one large lesion measuring 20 mm that can undergo serial biopsy) and at least five additional lesions measurable for assessment with no improvement over the four weeks prior to enrollment
KS patients with skin-only disease must have cutaneous lesions amenable to four 3 mm punch biopsies during the course of the study (either four separate lesions measuring >= 4 mm each OR two separate lesions measuring >= 8 mm each)
Preferentially radiologically by tumor growth or new lesions, or by
Participants must have cutaneous lesion(s) amenable to four (4) 5-mm tumor biopsies during the study (either 4 separate lesions measuring >= 5 mm each OR 2 separate lesions measuring >= 10 mm each) and at least five additional lesions measurable for assessment with no improvement over the past month
Patients with single or multiple cerebellar or cerebral cortex lesions are eligible
Diagnosis must be confirmed clinically at baseline with 1-2 lesions having been biopsied no sooner than 2 weeks prior to treatment
Primary lesions may be acceptable for enrollment
Radiation for symptomatic lesions within 14 days of study enrollment
Either complete disappearance of all lesions, or persistence of metastatic disease (stable disease) without unequivocal progression or the occurrence of new lesions
Presence of non-target lesions that have not previously been irradiated or biopsied; to allow for collection of needle-biopsies at Screening and after completion of Kevetrin treatment
Measurable disease, as defined by RECIST v1.1; previously irradiated lesions can be counted as target lesions if clearly progressing after radiation
One or more of the following “risk” criteria for failure with conventional SBRT treatment alone:\r\n* Peripheral tumor >= 4 cm in any dimension\r\n* Central tumor (i.e. gross tumor within 2 cm of a major bronchus/vessel, or heart/pericardium), including hilar lymph node(s)\r\n* Multiple tumors (i.e. satellitosis-defined T3-4, or bilateral synchronous primary lung cancer; note that the maximum number of total lesions allowable on this study for treatment with SBRT is 3 (three), and all lesions must be amenable to SBRT and treated with SBRT on this study; note that it is not necessary for all lesions felt to be malignant to be biopsied
Have measurable disease based on modified severity-weighted assessment tool (mSWAT); tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Radiotherapy within 14 days before the first dose of either study drug except localized radiation therapy for lytic bone lesions and plasmacytomas
No more than 10 treatable lesions as evaluated by an experienced interventional oncologic radiologist for eligibility and lesion accessibility as the ablation of more than 10 lesions becomes technically infeasible; these lesions must be treated in a two- to three-week time period from initial interventional radiology evaluation; lung and liver lesions can range from 1 cm to 7 cm for a single lesion and no greater than 5 cm for multiple lesions; there are no size criteria for the osseous lesions
The lesions will be amenable to a safe, ultrasound/computed tomographic/fluoroscopic guided percutaneous approach; the targeted metastases must be sufficiently separable from the central nervous system, major peripheral motor nerves, bowel, and bladder; all lesions must be amenable to treatment
Patients may not have received prior systemic or hepatic directed infusional/embolization therapies for advanced uveal melanoma; local therapies such as radiofrequency ablation or cryotherapy for metastatic disease are permitted but must have been performed at least 21 days prior to initiation of study therapy; lesions treated with local modalities such as radiofrequency ablation or cryotherapy may not be used as target lesions unless they demonstrate growth over a minimum of 3 months on subsequent imaging studies
Patients with symptomatic relapse, including those with new bone lesions, soft tissue plasmacytomas, an increase in the size of existing bone lesions or soft tissue plasmacytomas, decrease in hemoglobin, rise in serum creatinine or hypercalcemia
Patients are also considered to have progressive disease when:\r\n* New bone or soft tissue lesions (eg, plasmacytomas) are identified; or\r\n* There is an unequivocal increase in the size of previously existing lesions; or\r\n* The development of an otherwise unexplained serum calcium > 11.5 mg/dL is also a marker of progressive disease (PD)
Participants with multiple basal cell carcinomas, including participants with Gorlin syndrome, with at least 6 clinically evident basal cell carcinomas at the time of randomization, of which 3 measure 5 mm or more in diameter and are considered target lesions. All other lesions are considered to be non-target lesions
Histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma
Structurally unstable bone lesions suggesting impending fracture
2. If lesions are too small to be visualized or palpable for accurate injection.
Presence of more than 50 melanoma lesions
Subjects with NF-1 and only PN lesions that cannot be evaluated by volumetric analysis (only applicable to Part B).
Patients with NF1 and inoperable PN defined as PN that cannot be surgically completely removed without risk for substantial morbidity due to encasement of, or close proximity to vital structures, invasiveness, or high vascularity of the PN; the PN has to cause (stratum 1) or have the potential to cause (stratum 2) significant morbidity, such as (but not limited to) head and neck lesions that could compromise the airway or great vessels, paraspinal lesions that can cause myelopathy, brachial or lumbar plexus lesions that could cause nerve compression and loss of function, lesions that could result in major deformity (e.g., orbital lesions) or are significantly disfiguring, lesions of the extremity that cause limb hypertrophy or loss of function, and painful lesions; patients will be enrolled into stratum 1 or 2 based on PN related morbidity; histologic confirmation of tumor is not necessary in the presence of consistent clinical and radiographic findings, but should be considered if malignant degeneration of a PN is clinically suspected; a PN is defined as a neurofibroma that has grown along the length of a nerve and may involve multiple fascicles and branches; a spinal PN involves two or more levels with connection between the levels or extending laterally along the nerve; in addition to PN, all study subjects must have either positive genetic testing for NF1 or have at least one other diagnostic criterion for NF1 listed below (National Institutes of Health [NIH] Consensus conference):\r\n* Six or more café-au-lait macules (>= 0.5 cm in prepubertal subjects or >= 1.5 cm in post pubertal subjects)\r\n* Freckling in axilla or groin\r\n* Optic glioma\r\n* Two or more Lisch nodules\r\n* A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)\r\n* A first-degree relative with NF1
Radiotherapy delivered to non-target lesions within one week prior to starting study treatment or delivered to target lesions that will be followed on the study (NOTE: prior sites of radiation will be recorded)
Patients must have measurable disease in two dimensions and >= 2 cm is acceptable (or 1.5 cm if 0.5 slices are used, as in spiral computed tomography [CT] scans); lesions that are considered intrinsically non-measurable include the following:\r\n* Bone lesions\r\n* Leptomeningeal disease\r\n* Ascites\r\n* Pleural/pericardial effusion\r\n* Inflammatory breast disease\r\n* Lymphangitis cutis/pulmonis\r\n* Abdominal masses that are not confirmed and followed by imaging techniques\r\n* Cystic lesions\r\n* Lesions that are situated in a previously irradiated area
Measurable lesions are not required for admittance to the study - but are desirable.
Brain lesions with a propensity to bleed
Patients with presence of multiple bladder lesions
Expansion cohorts: Patients with metastatic melanoma with measurable, stage III (in transit lesions) or stage IVA, IVB or IVC disease at least two measurable lesions/tumors
Patients will have from 1 to 5 painful lesions and only the most painful lesion will be treated.
More than 5 painful lesions, or more than 1 requiring immediate localized treatment
Have measurable disease based on modified severity-weighted assessment tool (mSWAT); tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Patients must, in the opinion of the treating physician, be candidates for intralesional administration into cutaneous, subcutaneous, or nodal lesions; patients must have at least 2 injectable lesions
Patients with lesions to the nasal mucosa
Traumatic lesions/hematomas
T1N0M0 and T2N0M0 glottic lesions
Willingness to have photographs taken to document lesions
Patients with lesions of Gleason 7 or greater outside the planned treatment area.
Prostate with multiple cystic lesions.
Has lesions involving chest wall
Unmeasurable target tumor site by RECIST 1.1 or PRC (example [ex]: lesions < 2 cm on computed tomography [CT] or magnetic resonance [MR] scan, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis, non-fludeoxyglucose [FDG]-avid skin lesions)
Minimum of at least three discrete metastatic lesions in the bone and/or soft tissue amenable to whole body PET imaging per the judgment of study radiologist
Confirmed presence of somatostatin receptors (type 2) on technically evaluable tumour lesions documented by a positive Somatostatin Receptor Scan acquired within 6 months prior to screening (Visit 1) and showing minimally two lesions in at least one of the key organs; these images shall be available to be sent to the imaging core lab electronically to ascertain quality and admissibility
Fewer than five lesions in total and more than 25 lesions/organ detected by the previous somatostatin receptor scan in key organs: liver, lymph nodes, bone or lungs
Participants must present with a gadolinium-enhancing brain lesion (or lesions) that are thought by the neuroradiologist and the neurosurgeon to be consistent with high-grade glioma; these may be newly diagnosed lesions or recurrent tumors
Patients must have MRI findings reporting intraprostatic lesions suspicious for malignancy
Ability to detect lesions within prostate on MRI for biopsy
Has lesions involving chest wall
Patient has:\r\n* Liver lesions that are untreated liver lesions or \r\n* Changing treatment regimen/type and/or receiving a new form of treatment and/or has been on a treatment break (‘holiday’) for liver lesions
Adult subjects with oral lesions undergoing surgical resection (i.e., only patients who are scheduled to undergo a surgery of the head & neck area to remove or biopsy oral lesions will be eligible to participate in the study); patients with previous treatment are eligible
Patients with breast lesions that are non-palpable that require surgical removal
Lesions and/or clip targetable with image guidance
Patient must not have hemorrhagic lesions
Absence of target lesions (> 2.0 cm) on staging CT
Subjects must have solid tumors with malignant lesions in the thorax, abdominal cavity, head and neck region, or extremities (any histology) likely to benefit from palliative radiotherapy; subjects requiring palliative RT for lesions in the spine or lesions adjacent to the spinal cord are excluded from this study
Subjects enrolled into Part 1 must have metastatic lesions where repeated IT injections are not feasible and in whom SC injection is the only viable route of CMP-001 administration, based on Investigator judgment. Subjects with injectable lesions are NOT eligible to participate in Part 1. Subjects enrolled into Part 2 must have metastatic lesions that are amenable to repeated IT injections.
Radioiodine (RAI)-resistant disease as defined by one or more of the following criteria:\r\n* One or more measurable lesions that do not demonstrate RAI uptake\r\n* One or more measurable lesions progressive by RECIST 1.1 =< 14 months of prior RAI therapy\r\n* One or more measurable lesions present after cumulative RAI dose of >= 600 mCi\r\n* One or more measurable lesions that are fludeoxyglucose F-18 (FDG)-avid (> 5 standardized uptake value [SUV]), if positron emission tomography (PET)/CT scan performed; these lesions may also be RAI-avid
Patients with confirmed or suspected liver lesions
Any person with a lesion of the oral mucosa; persons with changes in existing lesions or those who develop new lesions can be re-evaluated, but it is not required
Purely cystic lesions
Participants with paraspinal, paratracheal, and mediastinal pathological lesions larger than 2 centimeters (cm) unless they are previously irradiated
Subjects with active oral lesions or other mouth/throat soreness within 7d of study randomization.
Patients in the measureable disease cohort must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Patients must have at least one “target lesion” to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
For patients with measurable disease, patient must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Patients must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site.
Patients must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as ‘non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Patients must have at least one “target” lesion” to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Patients must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST version 1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Patients with recurrence must have at least one “target lesion” to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1); tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Patients who have measurable disease must have at least one “target lesion” to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Patients must have at least one “target” lesion to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Patients must have at least one \target lesion\ to be used to assess response on this protocol as defined by RECIST 1.1 (Section 8.1). Tumors within a previously irradiated field will be designated as \non-target\ lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
Tumors within previous radiated field will be designated “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Patients with measurable disease must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site
Tumors within a previously irradiated field will be designated as \non-target\ lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Tumors within a previously irradiated field will be designated as \non-target\ lesions unless progression is documented;
Measurable disease (tumors within a previously irradiated field will be designated as \nontarget\ lesions unless progression is documented incontrovertibly either radiographically or pathologically; for clinicians relying on biopsy documentation of recurrence, this must be obtained to confirm persistence at least 90 days following completion of radiation therapy)
Patient must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST 1.1\r\n* Tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Patients must have at least one \target lesion\ to be used to assess response on this protocol as defined by RECIST version 1.1; tumors within a previously irradiated field will be designated as \non-target\ lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Patient must have at least one target lesion to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented or a biopsy is obtained to confirm persistent disease at least 90 days following completion of radiation therapy
Patients must have at least one \target lesion\ to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST); tumors within a previously irradiated field will be designated as \non-target\ lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
At least one \target lesion\ to be used to assess response, as defined by RECIST 1.1 criteria. Tumors within a previously irradiated field will be designated as \non-target\ lesions unless previous progression is documented;
Stage: clinical T1 >= 1.0 cm, T2 or T3, N0-3, M0; participants with multicentric or bilateral disease are eligible if at least one lesion meets stage eligibility criteria for the study (i.e., >= 1.0 cm operable breast cancer) and no tumor is human epidermal growth factor receptor 2 (HER2)-positive (3+ by immunohistochemistry [IHC] or in situ hybridization [ISH] amplified >= 2.0); in this circumstance, the investigator must determine which will represent the target lesion to be assessed for response; this should remain consistent throughout the study; the target lesion should be selected on the basis of its size (lesion with the longest diameter) and suitability for accurate repetitive measurements
Patients must have at least ONE of the following: 1) Bone disease, 2) Any amount of neuroblastoma tumor cells in the bone marrow, 3) At least one soft tissue lesion that meets criteria for a TARGET lesion, 4) At least one non-target soft tissue lesion that is not measurable, but had a biopsy positive for neuroblastoma and/or ganglioneuroblastoma at any time prior to enrollment or is MIBG avid
A minimum of 1 measurable Target Lesion (i.e., ? 10 mm longest diameter).
Prior therapy is allowed provided the following are met: at least 4 weeks since prior locoregional therapy including surgical resection, radiotherapy, or ablation; provided target lesion has increased in size by 25% or more or the target lesion was not treated with locoregional therapy
Patients with measurable disease must have at least one target lesion as defined by RECIST 1.1” to be used to assess response on this protocol
Presence of measurable disease per RECIST version (v)1.1; target 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.
The lesion is suitable for repeat measurement using computerized tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence of disease progression based on RECIST 1.1 to be deemed a target lesion.
Presence of at least 1 non-target lesion suitable for multiple biopsies while on treatment.
Tumor measurable by RECIST 1.1 including >= 1 target lesion not planned for biopsy
Prior therapy is allowed provided the following are met: at least 4 weeks since prior locoregional therapy including surgical resection, chemoembolization, radiotherapy, or ablation. Provided target lesion has increased in size by 25% or more or the target lesion was not treated with locoregional therapy. Patients treated with palliative radiotherapy for symptoms will be eligible 1 week after treatment as long as the target lesion is not the treated lesion
TARGET POPULATION
Prior irradiation to the planned radiation target lesion.
Subjects must have an area of tumor amenable to excisional biopsy for the generation of TIL separate from, and in addition to, a target lesion to be used for response assessment.
Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion
Patients with a target lesion located in a previously irradiated field
Presence of measurable disease per RECIST v1.1; target 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
Radiotherapy to a target lesion within the past 3 months prior to baseline imaging unless that area has demonstrated progression
Measurable disease (at least one target lesion)
Presence of at least one target lesion (distinct from treatment lesion and outside of treatment lesion radiation field) evaluable for response by irRECIST
The target lesion is one that either has never received external beam radiation or has been previously irradiated and has since demonstrated progression; any local irradiation of the target lesion or any non-target lesions via external beam, conformal or stereotactic radiation treatments must have occurred more than 4 weeks prior to study drug administration; any full cranial-spinal radiation, whether or not a target lesion is included in the field, must have occurred more than 3 months prior to study drug administration
At least 1 lesion accessible for biopsy in addition to the target lesion
A minimum of one measurable lesion defined as: \r\n* Meeting the criteria for measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) \r\n* Skin lesion(s) selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s)
Subjects must have at least one target lesion in breast/chest wall/axilla which is amenable to application of high intensity focused ultrasound:\r\n* The distance from the skin: A targetable portion of the tumor must be ? 5 mm from the skin\r\n* The rib cage should not be in the prefocal ultrasound path or behind the target area of the lesion (minimum distance from the posterior aspect of the target area to rib cage must be at least 10 mm)\r\n* Subject’s tumor must be larger than 9 mm in the anterior-posterior dimension (measured by ultrasound)\r\n* Subject’s tumor must be greater than or equal to 0.3 cubic centimeters
Presence of at least one target lesion (distinct from treatment lesion and outside of treatment lesion radiation field) evaluable for response by RECIST 1.1
Patients must have at least one focus of metastatic disease that is amenable to pre- and on-treatment biopsies; ideally the biopsied lesion should not be one of the target measurable lesions, although this can be up to the discretion of the investigators
Subjects must have measurable disease (at least one target lesion) as defined by RECIST 1.1; target 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
Measurable disease by RECIST 1.1 criteria (at least one target lesion outside of previous radiation fields or progressed within a previous radiation field)
Subjects with planned radiation therapy to a target lesion will be excluded
Measurable metastatic sites of disease outside of the target lesion undergoing palliative radiation based on RECIST 1.1 as assessed by the investigator
Subjects must have at least 1 lesion that is measurable by irRECIST\r\n* A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per irRECIST, and has clearly progressed\r\n* Subjects undergoing fresh tumor biopsies must have additional non-target lesions that can be biopsied at acceptable risk as judged by the investigator or if no other lesion suitable for biopsy, then an irRECIST target lesion used for biopsy must be >= 2 cm in longest diameter
A minimum of one measurable lesion defined as:\r\n* Meeting the criteria for measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)\r\n* Skin lesion(s) selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s)
Concurrent palliative radiotherapy for local pain-control may be allowed provided the subject completes the first cycle of treatment, does not meet criteria of progressive disease, and treated lesions will not be included in the target/non-target lesion assessment.
Patients must have anticipated residual measurable disease after resection of target lesion(s) for TIL growth
A minimum of one measurable lesion defined as:\r\n* Meeting the criteria for measurable disease according to irRECIST criteria\r\n* For patients with skin metastases, lesions selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s)
The subject must have at least 1 measurable target lesion >= 10mm in longest dimension that is in an anatomic location treatable by MR-HIFU. Note that for this study, lesions in bone WILL be considered measurable provided they meet the other criteria by Response Evaluation Criteria in Solid Tumors (RECIST) and are confirmed to be metabolically active on baseline studies by either metaiodobenzylguanidine (MIBG) uptake (for neuroblastomas) or positron emission tomography (PET) avidity. Target lesions should be located so that they can be adequately heated by a hyperthermia treatment cell with a diameter of up to 58 mm, centered at a depth of 35 to 80 mm from the skin. There should be no staples, implants, extensive scarring, or other highly ultrasound absorbing or reflecting tissue in the expected beam path. For the first 5 patients enrolled on this study only, the lesion must be located in the extremities or pelvis to be considered treatable by MR-HIFU.
Target lesion that has been previously irradiated
The target lesion must measure at least 15 mm in at least one dimension, and no more than 4 cm in any dimension
At least one measurable disease site that meets target lesion requirements
Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1, or lymphoma that fulfills the Deauville PET Criteria
Radiotherapy to the target lesion within the past 3 months prior to baseline imaging
Target lesion size for re-irradiation must be =< 2 vertebral bodies
The position and accessibility of the target lesion allows for the safe administration of multiple ablation cycles or deployments to achieve a probe dwell time of ? 45 minutes.
Symptomatic patients in need of surgery to the “target” lesion
Patients enrolled in the dose-expansion part of the trial must have at least one lesion that may qualify as a target lesion based on the RECIST 1.1 criteria.
Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
Complete obstruction of portal venous flow to the segment of liver that includes the target lesion
The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be =< 30% based on the postoperative/pre-enrollment computed tomography (CT) scan
For patients with skin metastases, lesions selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s)
The gross target volume (GTV) is suitable for motion management using 4 dimensional computed tomography (4D CT), internal target volume (ITV), or respiratory gating; in addition, the target coverage and normal tissue constraints must be met as specified in protocol accounting for the respiratory motion of anatomy as a whole (not just the tumor)
Have at least one target (ie, measurable) intracranial CNS lesion (?10 mm in longest diameter by contrast enhanced magnetic resonance imaging [MRI]). Lesions previously treated by stereotactic radiosurgery (SRS) or surgical resection should not be included as a target lesion. Lesions previously treated with whole brain radiation therapy (WBRT) may be included as a target lesion if (1) the last administration of WBRT was >3 months prior to the first dose of AP32788 and (2) unequivocal radiological progression of the lesion has been observed. Expansion Cohort 4 Specific Inclusion Criteria:
Inability to adequately perform volumetric measurement of at least 1 target lesion (e.g., due to the presence of artifacts from cochlear or auditory brainstem implants, ill-defined tumor margins resulting from the juxtaposition of tumors abutting each other, or sequela from prior irradiation to the target lesion); Note: patients with cochlear or auditory brainstem implants may participate if a target lesion can be accurately assessed
Radiation therapy for the target lesion in the 60 months preceding inclusion in the study
The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be less than or equal to 30% based on the postoperative/pre-enrollment computed tomography (CT) scan
Clear delineation of the extent of the target lumpectomy cavity not possible
A radiation planning computed tomography (CT) scan which demonstrates a target lumpectomy cavity that is not clearly delineated or a target lumpectomy cavity/whole breast reference volume > 30%
Target Lesion(s) must not be contiguous with, encompass or infiltrate major blood vessels.
Lesions that have had radiotherapy must show subsequent radiographic evidence of increase in size by at least 20% to be deemed a target lesion.
At least one radiologically measurable target lesion per RECIST version 1.1
At least 1 unirradiated target lesion measurable by RECIST
Patients must have at least ONE of the following: 1) Bone disease, 2) Any amount of neuroblastoma tumor cells in the bone marrow, 3) At least one soft tissue lesion that meets criteria for a TARGET lesion, 4) At least one non-target soft tissue lesion that is not measurable, but had a biopsy positive for neuroblastoma and/or ganglioneuroblastoma at any time prior to enrollment or is MIBG avid
Diagnosis of an advanced solid tumor malignancy; there must be a target tumor which is measurable, palpable or clearly identifiable under ultrasound or radiographic guidance and amenable to percutaneous injection of C. novyi-NT spores; the targeted lesion must have a longest diameter ? 1 cm and < 12 cm and be measurable as defined by RECIST 1.1 criteria; the target lesion must not be located in either the thoracic, abdominal or pelvic cavities or in the brain; there must be no clinical, no functional, and no radiographic evidence of bone involvement at the site of the target lesion
Multifocal or multicentric breast cancer is allowed if all the lesions are biopsied and are HER2 positive; largest lesion will be assigned the target lesion
One or more measurable lesion(s) (\target lesion[s]\) that can be accurately measured in at least 1 dimension
American Joint Committee on Cancer (AJCC) clinical stage I with T1 > 1.5 cm, stage II or III invasive breast cancer; participants with multicentric or bilateral disease are eligible if at least one lesion meets stage eligibility criteria for the study and no tumor is HER2-positive; in this circumstance, the investigator must determine which will represent the target lesion to be assessed for response; this should remain consistent throughout the study; the target lesion should be selected on the basis of its size (lesion with the longest diameter) and suitability for accurate repetitive measurements
Residual measurable disease after resection of target lesion(s) for TIL growth
Residual measurable disease after resection of target lesion(s) for TIL growth
Target Population
Target Disease Exceptions
Measurable (target) disease.
At least one target lesion that is measurable by RECIST 1.1 for solid tumors, or IWG 2014 for lymphoma
At least one site of disease that is measurable by RECIST (version 1.1) criteria that has not been previously irradiated; if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
Measurable disease (at least one target lesion) according to RECIST v1.1
At least one extra-renal measurable target lesion meeting the criteria of RECIST version 1.1
Have at least 1 measurable (i.e., target) lesion per RECIST v1.1.
Radiotherapy that involves the lung or mediastinum within 3 months prior to chemotherapy. (Note: there is no washout period for palliative radiation to non-target organs other than the lung or mediastinum. If radiation was to an intended target lesion within 3 months of baseline imaging studies, and the lesion is progressing within this time frame it may be considered as a target lesion after review and discussion with the Sponsor.)
At least 1 target lesion that is unirradiated and measurable by RECIST, Version 1.1
The target lesion is one that either has never received external beam radiation or has been previously irradiated and has since demonstrated progression; any local irradiation of the target lesion or any non-target lesions via external beam, conformal or stereotactic radiation treatments must have occurred more than 4 weeks prior to study drug administration; any full craniospinal radiation, whether or not a target lesion is included in the field, must have occurred more than 3 months prior to study drug administration
A minimum of one measurable lesion defined as: \r\n* Meeting the criteria for measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)\r\n* Skin lesion(s) selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s)
Target Population
Target Disease Exceptions
No interim time prior to study entry is required following prior radiation therapy (RT) for non-target lesions; however, patients must not have received radiation for a minimum of 4 weeks prior to study entry at the site of any lesion that will be identified as a target lesion to measure tumor response; lesions that have been previously radiated cannot be used as target lesions unless there is radiographic evidence of progression at the site following radiation or a biopsy done following radiation shows viable neuroblastoma; palliative radiation is allowed to sites that will not be used to measure response during this study
At least one measurable target lesion according to mRECIST meeting the following criteria:
Subjects whose only target lesion(s) is in bone will be excluded
A minimum of one measurable lesion defined as: \r\n* Meeting the criteria for measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)\r\n* Skin lesion(s) selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s)
Radiotherapy to the target lesion within the past 3 months prior to baseline imaging
Measurable disease with >= 1 target lesion
Target lesion previously embolized, perfused, or irradiated without objective evidence of progression before start of therapy to be considered for response assessment
Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1.
Target or non-target lesions according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
Measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1, and obtained by imaging within 28 days prior to registration for protocol therapy.
Patients must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST 1.1
In patients with multicentric or bilateral invasive breast cancers, all sampled lesions must be hormone receptor-positive and HER2-negative and have an Oncotype Dx recurrence score =< 25; one lesion (typically the largest) should be designated as the target lesion for which response to the neoadjuvant therapy will be judged
Unstable bone in the target lesion requiring surgical stabilization prior to radiation
At least one \target lesion\ to be used to assess response, as defined by RECIST 1.1 criteria;
Radiotherapy =< 3 weeks prior to registration, except if to a non-target lesion only
Must have target or non-target lesions as per RECIST 1.1.
Inflammatory process in target area
At least one targetable lesion appropriate for palliative SBRT and one non-target lesion
Radiation therapy to a study target lesion within 6 months
Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion.
Patients must have measurable disease per RECIST 1.1 criteria defined as at least one lesion that can be accurately measured in at least one dimension, and that has not been the target of local or regional therapy including transarterial chemoembolization, intra-arterial chemotherapy, ethanol or radiofrequency ablation
Medical contraindication to biopsy of target lesion
The tumour uptake observed in each target lesion (for target/non-target/measurable lesions definition see §Appendix 2, Sections 1 and 2, RECIST Criteria, Version 1.1) using OctreoScan® must be ? normal liver uptake observed on planar imaging (to be centrally confirmed) (§Appendices 5 and 6).
* Patients with complete response to first-line chemotherapy with no measurable target for SBRT/RT
the radiation field does not encompass a target lesion
The target lumpectomy cavity must be clearly delineated
Has ?1 lesion that meets the criteria for measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator/radiology assessment
Patients must have at least ONE of the following: 1) Bone disease, 2) Any amount of neuroblastoma tumor cells in the bone marrow, 3) At least one soft tissue lesion that meets criteria for a TARGET lesion.
Measurable (target) disease.
Measurable (target) disease.
Patients must have at least one additional lesion (measurable by RECIST v1.1 or non-target) identified as a control untreated lesion to be left untreated and followed for response.
At least one uni-dimensional HCC target lesion assessable by CT or MRI according to RECIST 1.1
Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1;
Subjects enrolled in Part B must have at least 1 lesion that may qualify as a target lesion
Have on CT imaging done within 28 days of Day 1 findings consistent with advanced ccRCC, including at least one extra-renal measurable target lesion meeting the criteria of RECIST version 1.1.
Lesions that have had radiotherapy must show subsequent radiographic evidence of increased size to be deemed a target lesion.
Diagnosis of an advanced solid tumor malignancy. There must be a target tumor which is measureable, palpable or clearly identifiable under ultrasound or radiographic guidance and amenable to percutaneous injection of C. novyi-NT spores. The targeted lesion must have a longest diameter ? 1 cm and ? 12 cm and be measurable as defined by RECIST 1.1 criteria. The target lesion must not be located in either the thoracic, abdominal or pelvic cavities or in the brain. There must be no clinical, no functional, and no radiographic evidence of bone involvement at the site of the target lesion.
Previously collected autologous stem cell product met the minimum collection target and minimum infusion target
Part 3: Patients must have target (?2 cm diameter) or non-target lesion cancer that is accessible for core biopsies before starting on study and after one cycle of treatment.
Patients can have previous brain metastasis that was completely surgically resected if the previously resected lesion is at least 1 cm from target lesion(s) for this study; the location of the previous resection cavity is determined by the post-resection MRI
Mirels Score < 8 (specific to target humeral lesion).
Measurable metastatic disease with a target lesion that has increased in size by 20% in maximal dimension either during or within six months after treatment with chemotherapy using a gemcitabine containing regimen
At least one soft tissue site that meets criteria for a TARGET lesion defined by:
where Target Lesions should be at least 10 mm from any other lesion
Radiation directed at target lesion within 28 days of registration
Target Population
Target Disease Exceptions
Lesions that have had radiotherapy must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
At least one target lesion. In patients with prior loco-regional therapy, the target lesion(s) must be located in area(s) outside previous treatment
Radiotherapy to the target lesions within 3 months prior lymphodepleting chemotherapy. A lesion with unequivocal progression may be considered a target lesion. There is no washout period for palliative radiation to non-target lesions.
Request for formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens if available and willingness of the participant to undergo mandatory fresh tumor biopsy unless determined medically unsafe or not feasible; a note from the study team should be provided documenting availability of tissue; if a target lesion is biopsied at screening, this lesion must be followed as non-target lesion after the biopsy unless it is the patient’s only target lesion; if there is only one target lesion, it should be followed as a target lesion regardless\r\n* The archival specimen should contain adequate viable tumor tissue\r\n* The specimen may consist of a tissue block (preferred and should contain the highest grade of tumor) or at least 30 unstained serial sections; fine-needle aspiration, brushings, cell pellet from pleural effusion, bone marrow aspirate/biopsy are not acceptable\r\n* Fresh tumor biopsy at progression will be required in cases where patients experience relapse after an initial response if medically safe
Have fatigue and/or two other target symptoms
Target lesion of any size
Target lesion located 1.5 cm or more away from visceral pleura based on the needle path
Presence of at least one target liver or other intra-abdominal lesion detected by standard staging scans that, in the judgment of study investigators, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging:\r\n* Target lesion must measure >= 1.0 cm in long axis diameter on computed tomography (CT) or magnetic resonance imaging (MRI)
Presence of at least one target lesion amenable to percutaneous tumor biopsy in the judgment of interventional radiology
No prior local therapy to target lesion
Presence of at least one target lesion detected by standard staging scans that, in the judgment of study investigators, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging:\r\n* Soft tissue/visceral organ target lesions must measure at 1 cm in long axis diameter on computed tomography (CT) or MRI\r\n* Target lesions in the bone must be visualized by CT or MRI (lesions present only on bone scan do not qualify)\r\n* For patients with target lesion in prostate/prostatic bed:\r\n** No contra-indications to endorectal coil insertion (e.g., patients with a prior abdominoperineal resection of the rectum or latex allergy).\r\n** No prior local treatment to the selected lesion; patients who have received prior radiation or ablative therapy to the prostate will be required to have biopsy-proven evidence of disease recurrence following completion of local therapy
Concomitant medications for treatment of the target lesion
Prior radiation therapy to the target lesion
Concomitant medications for treatment of the target lesion
Have a discreet surgical target
Part 2, Expansion: Participants must have measurable disease meeting the following criteria: i. Subjects with HCC: At least 1 measurable target lesion according to mRECIST
Prior radiation therapy to the target lesion
Set monthly accrual target >= 1/ and annual accrual target >= 12
Radiographically or clinically measurable disease with greater than or equal to (>=) 1 target lesion per IWG criteria for malignant lymphoma.
Target Population
Target Disease Exceptions
Disease must be evaluable as per RECIST 1.1 or RANO (for gliomas). At least one measurable target lesion is required in expansion cohort patients
Documentation of target and non-target lesion(s) status per RECIST1.1 post induction chemotherapy for patients with evaluable disease\r\n* Note: Evaluable disease is not required for study entry (patients with complete response [CR] or response sufficient to preclude measurable lesions are not excluded; such patients will be evaluated for PFS and OS, but not for response)
Patients must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm)\r\n* Note: The following do NOT qualify as measurable disease: \r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) \r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF)\r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement parameters noted above
Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice\r\n* Note: The following do not qualify as measurable disease: \r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF) \r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice\r\n* Note: The following do not qualify as measurable disease: \r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF) \r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice; Note: The following do not qualify as measurable disease: \r\n* Malignant fluid collections (e.g., ascites, pleural effusions)\r\n* Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n* Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n* Elevated tumor markers in plasma or cerebrospinal fluid (CSF)\r\n* Previously radiated lesions that have not demonstrated clear progression post radiation\r\n* Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice\r\n* Note: The following do not qualify as measurable disease: \r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF) \r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG)+ evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice; Note: The following do not qualify as measurable disease: \r\n* Malignant fluid collections (e.g., ascites, pleural effusions)\r\n* Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n* Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n* Elevated tumor markers in plasma or cerebrospinal fluid (CSF)\r\n* Previously radiated lesions that have not demonstrated clear progression post radiation \r\n* Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice\r\n* Note: The following do not qualify as measurable disease: \r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF) \r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\r\n** Bone lesions without an associated soft tissue mass >= 10 mm in greatest diameter; bone lesions with an associated soft tissue mass >= 10 mm in greatest diameter imaged by computed tomography (CT) or MRI are considered measurable
Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice\r\n* Note: The following do not qualify as measurable disease:\r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF)\r\n** Previously radiated lesions that have not demonstrated clear progression post radiation\r\n** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice\r\n* Note: the following do not qualify as measurable disease: \r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF) \r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice; Note: The following do not qualify as measurable disease:\r\n* Malignant fluid collections (e.g., ascites, pleural effusions)\r\n* Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n* Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n* Elevated tumor markers in plasma or cerebrospinal fluid (CSF)\r\n* Previously radiated lesions that have not demonstrated clear progression post radiation\r\n* Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Patients must have radiographically measurable disease (with the exception of those with neuroblastoma)\r\n* Measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm)\r\n* Note: the following do not qualify as measurable disease: \r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by metaiodobenzylguanidine (MIBG) scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted in patients with neuroblastoma who do not have measurable disease but have MIBG-avid evaluable disease \r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF) \r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurements noted above
GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of treatment with subprotocol specified therapy, the patients must have radiographically measurable disease; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice\r\n* Note: The following do not qualify as measurable disease:\r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n** Elevated tumor markers in plasma or CSF \r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1