[c09aa8]: / clusters / 9knumclustersv2 / clust_2862.txt

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Patients with neuroblastoma who do not have measurable disease but have iodine- - meta-iodobenzylguanidine positive (MIBG+) evaluable disease are eligible.
Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled
Treatment with therapeutic doses of metaiodobenzylguanidine (MIBG) ? weeks before first dose of study drug
Patients are eligible >= weeks after therapeutic I-MIBG or stem cell infusion to support I-MIBG, whichever is later
Patients who are unable to discontinue medications known to affect MIBG uptake (unless approved by the principal investigator [P.I.] or designee)
Patients must have evidence of MIBG avid disease as determined by diagnostic MIBG scan obtained within weeks of MIBG infusion; at least one MIBG avid target lesion that can be evaluated for response must be present at study entry; computed tomography (CT)/magnetic resonance imaging (MRI) evaluation of all sites of disease must be completed within weeks of MIBG infusion
Patients may enter this study with or without salvage therapy for recurrent tumor; patients must have fully recovered from the toxic effects of any prior therapy; \r\n* Myelosuppressive chemotherapy and/or biologics: must not have received within weeks of entry onto this study; ( weeks in the case of mitomycin C or nitrosourea-containing therapy)\r\n* Radiation therapy (XRT): weeks must have elapsed since completing radiation therapy to any site ( months in the case of craniospinal, whole lung); patients are excluded if they have received local radiation which includes any of the following:\r\n** cGy to more than % of both kidneys (patient must have at least one kidney that has not exceeded the dose/volume of radiation listed)\r\n** cGy to more than % of liver and/or cGy to more than % of liver\r\n** Prior MIBG therapy: should be at least days from previous I-MIBG therapy and have recovered completely from all clinically significant treatment associated toxicities; patients must not exceed a lifetime cumulative injected activity of mCi/kg for patients with neuroblastoma and mCi/kg for patients with other MIBG avid diseases; patients must have demonstrated a response to prior MIBG therapy (either clinical, pathological and/or radiographic improvement)
Patients for whom busulfan/melphalan consolidation therapy following treatment with I-MIBG is planned
Patients for who CEM (carboplatin, etoposide, melphalan) therapy is administered within days prior to I-MIBG therapy or for whom this therapy is planned within days following administration of I-MIBG
MIBG scan with positive uptake at minimum of one site
Minimum of six weeks is required following prior therapeutic doses of MIBG.
Diagnostic imaging magnetic resonance imaging (MRI) and/or computed tomography (CT) of the area to be treated within weeks of any treatment; baseline bone marrow biopsy and bone scan (with m-Tc-diphosphonate or metaiodobenzylguanidine [MIBG] scan [I-MIBG or I-MIBG]) from time of original diagnosis is required
Disease must be evaluable by metaiodobenzylguanidine (MIBG) scan; a positive MIBG scan must be present within 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 weeks after radiation was completed and must show viable neuroblastoma
Patients who have had prior treatment with I-MIBG who do not meet the re-treatment criteria
Patients with known MIBG-avid parenchymal brain metastases are excluded
Patients must have MIBG-avid NB and evaluable disease on MIBG scan at time of enrollment on protocol
INCLUSION CRITERIA FOR CCT: patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time of enrollment on protocol
Prior anti-GD therapy is not otherwise an exclusionary criteria unless it was given in combination with therapeutic I-MIBG.
Patients must have evidence of MIBG uptake into tumor at >= one site within weeks prior to entry on study and subsequent to any intervening therapy
Prior I-MIBG therapy is excluded
Patients must have at least ONE of the following (lesions may have received prior radiation therapy as long as they meet the other criteria listed below):\r\n* Bone disease\r\n** At least one metaiodobenzylguanidine (MIBG) avid bone site or diffuse MIBG uptake\r\n*** For recurrent/progressive or refractory disease a biopsy is not required regardless of number of MIBG avid lesions\r\n*** For persistent disease, if patient has only or MIBG avid lesions OR a Curie score of -, then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one site present at the time of enrollment (bone marrow, bone, or soft tissue) is required to be obtained at any time point prior to enrollment and two weeks subsequent to most recent prior therapy; if a patient has or more MIBG avid lesions OR a Curie score of >= then no biopsy is required for eligibility\r\n** If a tumor is known to be MIBG non-avid, then a patient must have at least one fludeoxyglucose (FDG)-positron emission tomography (PET) avid bone site present at the time of enrollment with biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma obtained at any time prior to enrollment and two weeks subsequent to most recent prior therapy\r\n* Any amount of neuroblastoma tumor cells in the bone marrow based on routine morphology (with or without immunocytochemistry) in at least one sample from bilateral aspirates and biopsies\r\n* At least one soft tissue lesion that meets the criteria for a TARGET lesion as defined by:\r\n** SIZE: Lesion can be accurately measured in at least one dimension with a longest diameter >= mm, or for lymph nodes >= mm on short axis; lesions meeting size criteria will be considered measurable\r\n** In addition to size, a lesion needs to meet ONE of the following criteria:\r\n*** MIBG avid; for patients with persistent disease only: if a patient has only or MIBG avid lesions OR a Curie score of -, then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one site present at time of enrollment (either bone marrow, bone and/or soft tissue) is required to be obtained at any time point prior to enrollment and at least two weeks subsequent to most recent prior therapy; if a patient has or more MIBG avid lesions OR a Curie score of >= then no biopsy is required for eligibility\r\n*** FDG-PET avid (only if tumor is known to be MIBG non-avid); these patients must have had a biopsy confirming neuroblastoma and/or ganglioneuroblastoma in at least one FDG-PET avid site present at the time of enrollment done prior to enrollment and at least two weeks subsequent to the most recent prior therapy\r\n*** Non-avid lesion (both MIBG and FDG-PET non-avid); these patients must have had a biopsy confirming neuroblastoma and/or ganglioneuroblastoma in at least one non-avid lesion present at the time of enrollment done prior to enrollment and at least two weeks subsequent to the most recent prior therapy
Patients with neuroblastoma who do not have measurable disease but have MIBG-avid evaluable disease are eligible
Patients must have evidence of MIBG uptake into tumor at ? one site within weeks prior to entry on study and subsequent to any intervening therapy.
They have had previous I- MIBG therapy
Patients must have at least ONE of the following:\r\n* Measurable tumor on magnetic resonance imaging (MRI), computed tomography (CT) scan obtained within weeks prior to study entry; measurable is defined as >= mm in at least one dimension on spiral/helical CT that is metaiodobenzylguanidine (MIBG) avid or demonstrates increased fludeoxyglucose (FDG) uptake on positron emission tomography (PET) scan\r\n* MIBG scan obtained within weeks prior to study entry with positive uptake at a minimum of one site; this site must represent disease recurrence after completion of therapy, progressive disease on therapy, or refractory disease during induction\r\n* Patients with resistant/refractory soft tissue disease that is not MIBG avid or does not demonstrate increased FDG uptake on PET scan must undergo biopsy to document the presence of viable neuroblastoma; biopsy is not required for patients who have new site of soft tissue disease (radiographic evidence of disease progression) regardless of whether progression occurs while receiving therapy or after completion of therapy\r\n* Note: Patients with elevated catecholamines (i.e., > x ULN) only or bone marrow disease only are NOT eligible for this study
Patients are eligible >= weeks after therapeutic I-MIBG provided that all other eligibility criteria are met
Prior therapeutic MIBG is allowed
Patients must have measurable disease; patients with a diagnosis of neuroblastoma with Iobenguane (MIBG) avid disease only are permitted to enroll on this study
At least one MIBG avid bone site or diffuse MIBG uptake.
For recurrent/progressive or refractory disease, a biopsy is not required regardless of number of MIBG avid lesions
For persistent disease, if patient has only or MIBG avid lesions OR a Curie core of - , then biopsy confirmation of neuroblastoma and/or ganglioneuroma in at least one site present at the time of enrollment (bone marrow, bone or soft tissue) is required to be obtained at any time point prior to enrollment and two weeks subsequent to most recent prior therapy. If a patient has or more MIBG avid lesions OR a Curie Score of ? then no biopsy is required for eligibility.
In addition to size, a site needs to meet one of the following criteria: MIBG avid. For patients with persistent disease only: If a patient has only or MIBG avid lesions OR a Curie Score of - , then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one site present at time of enrollment (either bone marrow, bone and/or soft tissue) is required to be obtained at any time point prior to enrollment and at least two weeks subsequent to most recent prior therapy. If a patient has or more MIBG avid lesions OR a Curie Score of ? then no biopsy is required for eligibility.
FDG-PET avid (only if tumor known to be MIBG non-avid). These patients must have had a biopsy confirming neuroblastoma and/or ganglioneuroblastoma in at least one FDG-PET avid site present at the time of enrollment done prior to enrollment and at least two weeks subsequent to the most recent prior therapy.
Non-avid lesion (both MIBG and FDG-PET non-avid). These patients must have had a biopsy confirming neuroblastoma and/or ganglioneuroblastoma in at least one non-avid lesion present at the time of enrollment done prior to enrollment and at least two weeks subsequent to the most recent prior therapy.
Measurable or evaluable tumors. Subjects with neuroblastoma that is only detectable by Meta-iodobenzylguanidine (MIBG) scan are eligible. Subjects with neuroblastoma that is only detected by bone marrow aspirate/biopsy or elevated homovanillic acid / vanillylmandelic acid (HVA/VMA) are not eligible.
Participants who are less than weeks post- I-metaiodobenzylguanidine (mIBG) therapy.
For neuroblastoma patients only, a positive MIBG (MIBG not required if subject's neuroblastoma is previously determined to not uptake MIBG), abnormal urinary catecholamine levels, or positive bone marrow biopsy/aspirate.
Use of medications known to interfere with I-mIBG uptake (principal considerations are phenylephrine and pseudoephedrine containing compounds which need to be discontinued for hours, and labetalol which needs to be discontinued for weeks)
PHASE I: All patients must have MIBG-avid disease and evaluable disease on MIBG scan at the time of enrollment onto the protocol
EXPANSION COHORT: Patients must have MIBG-avid disease and evaluable disease on MIBG scan at the time of enrollment onto the protocol
Patients must have MIBG evaluable disease which is defined as evidence of uptake into tumor at >= one site within weeks prior to entry on study and subsequent to any intervening therapy
Patients must meet eligibility criteria for I-MIBG therapy