--- a +++ b/clusters/3009knumclusters/clust_242.txt @@ -0,0 +1,157 @@ +Significant hearing loss that would prevent cisplatin administration +Not participating in another weight loss, physical activity or dietary intervention clinical trial; co-enrollment in some trials involving pharmacologic therapy is allowed; participants in both arms are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial +Weight =< 300 lbs (pounds) +Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss from tumor-related otitis media is allowed +Significant pre-existing hearing loss, as defined by the patient or treating physician +Experienced weight loss > 10% over approximately 2 months prior to first dose of study therapy +>10% weight loss over the 28 days prior to consent. +Unintentional weight loss > 10% within 30 days prior to registration +Patient has a > 10% decrease in weight between Baseline visit and within 72 hours prior to randomization. +Cohort A: Histologically confirmed locally advanced or metastatic solid tumor malignancy other than clear cell renal cell carcinoma with progression on at least one prior systemic therapy and presence of biallelic loss of SETD2 detected in tumor tissue detected using a Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing panel (e.g. UCSF500, FoundationOne); biallelic loss will be defined by one or more of the following:\r\n* Pathogenic or likely pathogenic loss-of-function SETD2 mutation with mutant allele frequency (MAF) > 50%\r\n* Pathogenic or likely pathogenic loss-of-function SETD2 mutation with MAF > 2 times the MAF of other oncogenic mutations detected in the tumor sample\r\n* Pathogenic or likely pathogenic loss-of-function SETD2 mutation with concomitant loss of chromosome 3p\r\n* Pathogenic or likely pathogenic loss-of-function SETD2 mutation with copy-neutral loss of heterozygosity +> 10% unintentional weight loss within the past month +Grade >= 2 sensorineural hearing loss +Unintentional weight loss >10% within 4 weeks prior to study registration. +Weight over 410 pounds. +Significant weight loss (> 20% of body weight) within past 6 months prior to inclusion into the trial +Existing major organ dysfunction > Grade 2, with the exception of hearing loss, hematological status, kidney and liver function +Participation in a diet (Atkins, Weight Watchers, Best Life, Nutrisystem, South Beach, Jenny Craig, Paleo Diet, Zone etc) or weight loss plan within 28 days prior to day 1 of treatment +Has experienced weight loss > 10% over 2 months prior to first dose of study therapy +Patient weight > 400 pounds (lbs) (table limit for PET scanner) +Weight loss of > 10% in the past 6 months +Weight loss < 10% in preceding 3 months prior to diagnosis +Recent history of unintentional weight loss > 10% of current body weight in the past 3 months. +Patients with greater than grade 2 hearing loss +Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry +Significant weight loss (> 20% of body weight [BW]) within past 6 months prior to inclusion into the trial or actual body weight of less than 50 kg +Weight >= 120 pounds (lbs) +Weight < 120 lbs at time of study enrollment +No systemic or B symptoms (fever >38°C for 3 consecutive days; recurrent, drenching night sweats; unintentional weight loss exceeding 10% body weight in the last 6 months. +Loss of complete hematologic response (CHR) +> 50% loss of vertebral body height +Presence of disease-related constitutional symptoms:\r\n* Weight loss >= 10% over the preceding 6 months\r\n* Significant fatigue (i.e., Eastern Cooperative Oncology Group [ECOG] performance status [PS] 2 or worse; inability to work or perform usual activities)\r\n* Fevers higher than 100.5°F or 38.0°C for 2 or more weeks without other evidence of infection\r\n* Night sweats for more than 1 month without evidence of infection +Significant weight loss (> 10% of body weight [BW]) within past 6 months prior to inclusion into the trial +Weight loss of > 10% over the past 6 months which is due to tumor wasting syndrome +History/physical examination within 4 weeks prior to registration, including assessment of weight and weight loss in past 6 months +Weight loss < 15% in the 3 months before diagnosis +Weight > 12 kilograms +Weight loss > 10 percent within 6 months prior to starting treatment that is determined by the investigator or treating physician to be directly related to tumor and not directly related local esophageal symptoms (e.g. dysphagia, odynophagia) +Subjects with recent significant or unexplained weight loss that the investigator feels may pose an unacceptable risk for enrollment; candidates who are overweight and have lost weight intentionally via diet or exercise should not be excluded, for instance +Normal auditory acuity: defined as a normal age-related audiogram without significant hearing loss. +Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry +Grade >= 2 sensorineural hearing loss +Hearing loss >= grade 2 +Cohort 2 (MTD) only: weight loss of > 5% at any point after a cancer diagnosis or within 3 months prior to this cancer diagnosis; Note: no documentation from the medical record is necessary +A minimum of any one of the following constitutional symptoms: Unintentional weight loss >10% within the previous 6 months prior to screening Extreme fatigue (unable to work or perform usual activities) Fevers of greater than 100.5?F for ?2 weeks without evidence of infection Night sweats without evidence of infection. +Significant hearing loss that would prevent cisplatin administration +Patients who are ineligible to receive cisplatin:\r\n* Creatinine clearance of less than 60 mL/minute, hearing loss of 25 decibels (dB) at two contiguous frequencies, grade 2 or higher peripheral neuropathy, or New York Heart Association class III or higher heart failure\r\n* Hearing test will not be routinely done, it will only be done if patients report hearing loss at baseline or during treatment +Patients must have histologically confirmed B-cell CLL/SLL according to World Health Organization (WHO) criteria with at least one of the following indications for treatment:\r\n* Progressive disease or marked splenomegaly or hepatomegaly\r\n* Anemia (hemoglobin [Hgb] < 11 mg/dL) or thrombocytopenia (platelets < 100,000 /mm^3)\r\n* Unexplained weight loss exceeding 10% of body weight over the preceding 6 months\r\n* Fevers > 100.5 degrees F or night sweats for greater than 2 weeks without evidence of infection\r\n* Progressive lymphocytosis, with an increase exceeding 50% over a 2 month period or a doubling time of less than 6 months\r\n* Significant fatigue (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03 grade 2 or higher) +Patients with >= 10% weight loss within the past month +Patients should have an audiogram at baseline, and patients with pre-existing hearing loss or hearing loss during treatment should be assessed frequently during cisplatin therapy +Unintentional weight loss >= 5% of body weight within the past 6 months +Loss of INI1 confirmed by IHC, or +For Cohort C: Has a history of loss of consciousness within 12 months of the screening visit +Patients must not have more than 10% weight loss in the past 6 months +unintentional weight loss of 10% or more within the previous 6 months +Unintended weight loss >10% in 6 months preceding study entry. +Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone +Patients with weight loss =< 10% over the past 3 months +Weight >= 100 lbs +Weight < 100 lbs +Unintentional weight loss >= 10% in the last 3 months (mos) +10% weight loss within the past month +Preexisting grade >= 2 hearing loss +Currently actively involved in another diet intervention study or organized weight loss program +> grade 1 hearing loss or tinnitus +Significant weight loss (> 10%) in the prior 3 months +history of traumatic brain or head injury with loss of consciousness +unexplained loss of consciousness within the last 12 months, +Current body mass index (BMI) >= 25 kg/m^2 and weight =< 400 lbs, and willing to lose > 5% of their body weight; NOTE: participants should not have weight loss greater than 5% of body weight in the last 6 months; all weights for determination of eligibility may be determined by self-reported of weight if not documented in the medical records; exceptions that are felt to be due to surgical or other procedures (e.g., mastectomies or reconstruction) may be allowed with prior approval of the Protocol Chair/designee +Serious/uncontrolled medical condition, at the discretion of the protocol chair/designee, likely to hinder accurate measurement of weight, including any condition: for which weight loss is contraindicated, which would likely cause weight loss, or which would affect adipokine and inflammatory markers (e.g., other active malignancy, end stage renal disease [ESRD] on dialysis, cirrhosis, autoimmune disease, adrenal disease, and history of bariatric surgery) +Currently enrolled or planning to enroll in a weight loss program (e.g., Innergy, Weight Watchers, Jenny Craig, Nutrisystem, and Medifast); participants also agree not to enroll in such a program for the duration of study participation (regardless of randomization) +Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry +Extensive (> 50%) height loss of the involved vertebral body +Preexisting grade >= 2 hearing loss +Hearing: a) No clinically significant hearing loss, defined in Section 6.2, number 9. +Patients with significant hearing loss are not eligible for study participation defined as hearing loss that affects everyday life and/or for which a hearing aid is required. +Patient's nutritional and general physical condition must be considered compatible with the proposed radiotherapeutic treatment (cannot have unintentional and/or surgically unrelated weight loss > 20% in the preceding 3 months); this assessment is a standard of care assessment for this patient population; this requirement can be waived by the investigator if the subject has an identifiable procedure which is the immediate and sole cause for the weight loss without an underlying pathological cause; an example of a situation like this would be if a participant is found to need a tonsillectomy during the pretreatment evaluations; it’s obvious that this scenario would be a non-pathological reason for such a weight loss; the Principal Investigator (PI) will only have this ability to waive this criterion if and only if he can substantiate and document that the weight loss does not have a pathological etiology and will correct itself within a reasonable and acceptable period of time +More than 10% weight loss in 6 months, given the poor prognostic sign of significant weight loss, and the possible intolerance to combined modality therapy +Absence of combined 1p/19q loss +Ability to maintain their weight +Evidence of active hair loss +Significant weight loss (> 10% of body weight [BW]) within past 6 months prior to inclusion into the trial +Patients with a tumor involving a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone +Weight loss >20% in the previous 6 months. +Current (within 3 months of study commencement) use of weight loss medication(s) +History of weight loss surgery +Weight loss =< 5% in the previous six months unless weight loss is intentional (per judgment of study medical doctor [MD]) +Significant cancer-related weight loss (?10%)within four weeks prior to treatment start +Unexplained weight loss exceeding 10% of body weight over the previous 6 months. +Unintentional weight loss (10% within the previous 6 months) +weight loss of greater than 10% within the prior 6 months +Significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial +Body weight less than 300 pounds (lbs.), as dictated by the weight limit for dual x-ray absorptiometry (DXA) scanner and Saris CycleOps Phantom 5 bicycle +Have not experienced a weight reduction >= 10% within past 6 months +Mild cancer cachexia, determined as a proxy screening strategy, by an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 and a history of mild to moderate weight loss (i.e. =< 10% loss of patient reported usual body weight (pre-cancer diagnosis); patients may also be eligible without a history of weight loss if their treating physician identifies mild cancer cachexia associated with a non-cancer related diagnosis (e.g. chronic obstructive pulmonary disease [COPD], etc.) and meets ECOG criteria +Presence of unintentional weight loss ranging from >= 2 - =< 15% in last 12 months +Patient is taking medications or supplements for weight loss currently or within the past 3 months +Weight loss of greater than 5% in the previous 6 months +Current, recent (< 1 year), or planning to join a weight loss program or take appetite suppressants +Participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials +Active blood loss +Weight of < 205 kgs +Significant history of head injury/trauma as defined by loss of consciousness for more than one hour +Weight of < 205 kgs +Weight change > 5% within 3 months of enrollment +> 50% loss of vertebral body height +Significant orthopedic or muscluloskeletal condition that does not allow weight bearing +Presence of cancer-related cachexia defined as an involuntary weight loss of at least 5% of the pre-illness body weight over the previous 6 months +History of stroke or head injury associated with loss of consciousness within 12 months of registration +Estimated blood loss (EBL) > 1 liter +Participation in other diet-based weight loss programs (i.e. Patient should not be currently enrolled in Weight Watchers, Jenny Craig, Nutrisystem, etc.) +Current use of commercial or natural/herbal weight loss supplements +Must not be participating in another formal weight loss program +Enrollment in a structured weight loss program in the past 6 months +Weight loss =< 10% in 3 months prior to diagnosis +Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone +Previous or existing pathology of the inner ear with or without hearing loss (i.e. sudden sensorineural hearing loss, Meniere’s disease, autoimmune inner ear disease) +Must be willing to have height and weight recorded at each aspiration visit +Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue +Patients who have had surgery for weight loss\r\n* Note: women will not be excluded if their baseline lifestyle assessment indicates a healthy eating and moderate physical activity with the exception of the exclusion criteria above +Use of metformin, insulin, steroids or prescription weight loss or anti-psychotic drugs within the prior 3 weeks +Participation within the past 6 months on a structured weight loss program such as Weight Watchers® +Use of metformin, insulin, steroids or weight loss or anti-psychotic drugs within the prior 3 weeks +Participation within the past 6 months on a structured weight loss program such as Weight Watchers +Involvement in a weight loss program +Weight loss greater than 10% in prior 4 weeks +Weight < 205 kilograms +Currently enrolled or planned to enroll in weight loss program +Use of prescription weight loss medication(s) (e.g., lorcaserin, topiramate/phentermine, phentermine, liraglutide, and bupropion/naltrexone), including off label use of drugs for weight loss or over-the-counter weigh loss medications such as Orlistat within the past 6 months +Are on a weight loss program +Currently involved in a supervised program for weight loss +Use of insulin or other diabetes medications that would require additional medical monitoring during weight-loss; use of medications for weight loss or that may impact weight or glucometabolic function (e.g. corticosteroids) +Serious medical conditions where weight loss is contraindicated +Participants who are already enrolled in, or planning to enroll in another research study where weight loss is targeted will be excluded +Subjects must have a stable weight (have not gained or lost 25 pounds in the last 6 months) +Subjects who are part of any structured weight loss programs (e.g. Weight Watchers, etc.) are not eligible +Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program +Weight loss > 5% of body weight in the last 6 months based on self-report +Hearing loss greater than grade 1 +No concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, insulin-like growth factor 1 (IGF-1) or their receptors +Must be weight stable, as defined by staying within 10 percent of their current weight for 6 months +Current participation in a weight-loss program +Weight greater than the 400-lb weight limit of the PET scanner +Greater than 400 pounds in weight +Weight exceeding capacity of imaging table +Patients/subjects whose weight does not exceed 275 lbs +Weight < 350 lbs (patient bed max weight) +Weight greater than the 400-pound (lb) weight limit of the PET scanner +Patient who weighs more than the weight limit for the PET table +Weight > 350 lbs +Weight over 350 lbs. +Patents must have no contraindication to cisplatin chemotherapy including no clinically significant hearing loss unless willing to accept the potential of further loss of hearing, no symptomatic peripheral neuropathy +Weight exceeding capacity of imaging table +Weight > 300 pounds (lbs) +Body weight greater than 400 pounds (limit of Tanita scale) +Currently actively involved in another diet intervention study or organized weight loss program +Experienced unexplained weight loss of 15-pounds or more during six months prior to enrollment +Use of any antidiabetic, weight loss, or appetite control medication