Search Results
A Parallel Group Treatment, Phase 2a, Double-blind, Two-arm Study to Investigate the Efficacy and Safety of Farudodstat Tablets Compared with its Placebo in Male or Female AlopeciaAreata Participants Aged 18 Years and Older with 50% or Greater Scalp Hair Loss (FAST-AA)
The main purpose of the study is to see whether farudodstat, taken orally for 12 weeks, can help people with alopecia areata and to find out if farudodstat is safe and tolerable when compared to placebo. The placebo is a pill that looks like farudodstat tablet but has no drug or other active ingredient in it.
• at least 18 years old
• weight at least 40 kg (88 lbs)
• severe or very severe Alopecia Areata (AA)
• contact study staff for additional criteria for AA
• history of androgenic alopecia or female pattern hair loss prior to AA or other types of hair loss
• history or presence of hair transplants
• other scalp disease that may impact AA assessment or require topical treatment (including, but not limited to scalp psoriasis, seborrheic dermatitis, actinic keratosis)
Listening effort in people with hearing impairment
The purpose of this research is to understand the effort needed to understand speech if hearing is impaired. Listening effort is higher in people with hearing impairment and has wide-ranging negative consequences across many aspects of a person’s life. The goal of this project is to explore factors that make listening effortful, with special focus on the need to repair perceptual mistakes by relying on context.
• There are two categories of participants: either people with cochlear implant (one or two cochlear implants) or people with normal hearing in both ears. All participants must be 50-75 years old.
• non native English speakers
Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study
This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to treat medically intractable symptoms.
• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
• history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
• other significant neurological disorder
• history of dementia or cognitive impairment
• post-operative complications or adverse effects of DBS
A Phase 1b/2 Study of Abemaciclib in Combination with Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination with Temozolomide (Part B) in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors and Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients with Relapsed/Refractory Neuroblastoma (Part C). Protocol Number: I3Y-MC-JPCS
The study's purpose is to see if the drug abemaciclib is safe and effective in combination with temozolomide and irinotecan (Part A) and abemaciclib in combination with temozolomide (Part B) in pediatric and young adult participants with relapsed/refractory solid tumor and abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients with Relapsed/Refractory Neuroblastoma (Part C).
• Parts A and B only: participants must be less than or equal to 18 years of age and with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies
• Part C only: participants must be less than (<) 21 years of age and with first relapse/refractory neuroblastoma and with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies Parts A, B & C:
• participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade = < 1 at the time of enrollment
• able to swallow and/or have a gastric/nasogastric tube
• received allogenic bone marrow or solid organ transplant
• diagnosed and/or treated additional malignancy within 3 years prior to enrollment that may affect the interpretation of results, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or breast cancers
• pregnant or breastfeeding
R01HL153613: Comprehensive Proteomic Classifier for the Molecular Characterization of Pulmonary Sarcoidosis
This study proposes to collect lung fluid to identify potential biomarkers associated with pulmonary sarcoidosis.
• age 18-80
• contact umnsarc@umn.edu for inclusion/exclusion criteria
• history/current use of cigarette, e-cigarette, vaping or marijuana smoking
• history/current use of nicotine products
• presence of underlying chronic condition
• inability to undergo procedure using IV sedation
• weight < 110 lbs. & BMI > 35 kg/m2
• pregnant and/or breast feeding
• history/current use of chronic immunosuppressive medications
• contact umnsarc@umn.edu for inclusion/exclusion criteria
Visual Perception in Visual Snow Syndrome
This study seeks to understand visual perception in people with Visual Snow Syndrome and how this relates to brain function.
A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA)
The purpose of the study is to see if ianalumab, compared to placebo, is effective and safe for treating wAIHA. A placebo looks like the study drug, ianalumab, but does not contain any active ingredient. Ianalumab belongs to a class of drugs called monoclonal antibodies. Monoclonal antibodies are molecules that can recognize and stick to a specific protein expressed on the cell surface or released free in the body. Participants will receive study drug (ianalumab or placebo) through the vein every 4 weeks (4 doses in total) during the treatment period.
• people with documented primary or secondary wAIHA
• had an insufficient response to or relapsed after one or more treatments
• Hemoglobin concentration at screening between 5 g/dL and 10 g/dL and experiencing symptoms of anemia
• dose of supportive medication must be stable for at least 4 weeks
• wAIHA due to disease involving bone marrow
• prior use of B-cell depleting therapy (e.g., rituximab) within 12 weeks prior to starting the study
• active viral, bacterial or other infections that require systemic treatment at time of screening, or a history of recurrent clinically significant infection
• positive for hepatitis C virus, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb)
• contact study staff for additional criteria
Personalized immunomodulation in pediatric sepsis-induced MODS (PRECISE)
This is a large-scale multi-center study of personalized, targeted immune modulation in childre with sepsis-induced multiple organ dysfunction syndrome (MODS). This study is titled the “PeRsonalizEd immunomodulation in pediatriC sepsIS-inducEd MODS (PRECISE)”. The study includes two concurrent, immunophenotype-driven placebo controlled randomized controlled trils (RCTs) that will address the central hypothesis that individualized, pathophysiology-specific immunomodulation will improve outcomes from sepsis-induced MODS in children
CLINPRT-7: Intermediate Patient Population Expanded Access Protocol for MBP134 for Patients with Sudan Virus Disease (SVD)
The purpose of this open-label Expanded Access Protocol (EAP) is to provide access to MBP134, for treatment of Sudan Virus Disease (SVD). Patients will receive a single IV infusion of 50 mg/kg MBP134. Patients will be monitored and assessed daily through discharge for safety and the incidence of serious adverse events (SAEs), and of all adverse events (AEs) during infusions.
• people of any age who have a documented positive RT-PCR for Sudan Virus Disease (SVD) in the last 10 days
• OR a documented positive RT-PCR test for SUDV more than 10 days ago but continue to have symptoms of SVD
• OR acute symptoms compatible with SVD and a close contact with some who has RT-PCR confirmed SVD
• OR Infants born to mothers who have a positive RT-PCR results for SUDV within 10 days of birth or with a documented positive RT-PCR test for SUDV in >10 days but with ongoing symptoms of SVD
• women of who are of child-bearing age must use highly effective contraception for 90 days after receiving the medication
• any medical condition that, in the opinion of the physician, would unreasonably increase risk of side effects (study staff will assess)
AHOD2131: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
A multicenter, single arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who have Hb >=10 g/dL in response to anti-C5 antibody and switch to iptacopan
This is a multicenter, single-arm, open label trial, with iptacopan treatment for 24 weeks in adult PNH patients. Eligible participants must have a mean Hb ≥10 g/dL in response to a stable regimen with anti-C5 for at least 6 months and must be transfusion free for the same period.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis (VALOR)
In this study, brepocitinib will be compared to a placebo. Brepocitinib is an investigational medicine because it has not yet been approved by any regulatory agency for use. Researchers will compare the results of taking the placebo to the results of taking the study medicine to see if there are any differences. This medicine may be helpful for your disease, but we do not have any information about this yet. 67% of participants will receive brepocitinib and 33% will receive the placebo which will be decided randomly by chance. Participation will last for up to 64 weeks (15 months). Visits will be scheduled about every 4 to 6 weeks.
• diagnosis of dermatomyositis
• active muscle and skin disease or being treated with medications
• age 18-75
• weight at least 40 kg, less than 130 kg and a BMI less than 40 kg/m2
• history of cancer in past 5 years
• dermatomyositis with irreversible muscle involvement
• active or recent infections
MT2019-38: Development and Psychometric Testing of a Pediatric Chronic Graft-Versus-Host Disease (GVHD) Symptom Scale (PCSS)
The purpose of this study is to develop a questionnaire specifically designed for children and adolescents, which will help health care providers to better measure how bothersome symptoms of cGVHD are for children and adolescents living with cGVHD. Another purpose of this study is to design a caregiver companion questionnaire, to allow caregivers to measure how bothersome the symptoms of cGVHD are for their child/adolescent.
• children aged 5 to 17 years old, who have undergone prior allogeneic stem cell transplant
• clinical diagnosis of Graft vs Host Disease (cGVHD)
• currently receiving systemic treatment for cGVHD (including phototherapies), or has had systemic therapy for cGVHD tapered to discontinuation within the past 12 months -eligible caregiver proxy who is willing to participate in the study
• see link to clinicaltrials.gov for complete criteria
• participant's cognitive ability would compromise their ability to participate in study related procedures
• study staff will review
LTx READY CF 2: A Multi-Site RCT: Lung Transplant Resources for Education And Decision-making for Your CF 2 Study: A Multi-Site Randomized Controlled Clinical Trial
The primary study objective is to determine whether “Take on Transplant” (ToT), a CF-specific Lung Transplant (LTx) educational website, improves patient-reported preparedness for LTx discussions, as measured by the Preparation for Decision Making (PrepDM) Scale at 3 months after randomization, compared to an attention control transplant website (unos.org, UNOS).
Global Patient Registry of Inherited Retinal Diseases
The purpose of this research study is to collect timely and relevant data that will support the evolving research needs of the Inherited Retinal Disease community (IRD), in order to provide insights that can be used to improve patient management, and to inform development of future treatments. No visits, assessments, or procedures are mandated, and follow-up will be captured as part of your standard of care. The planned length of registry is of 8 years with a potential to extend the duration as needs evolve.
• at least 3 years old
• documented genetic diagnosis of X-linked retinitis pigmentosa (XLRP) or Achromatopsia (ACHM) with any signs or symptoms of disease
• Caregiver participants must be at least 18 years old and identified by the participant as the primary care giver
• received a treatment in an Inherited Retinal Disease (IRD) related interventional trial, or is being screened for an IIRD-related interventional trial
• Caregiver participant has an IRD and has visual impairment
A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON? (Lufepirsen Ophthalmic Gel) in Subjects with Persistent Corneal Epithelial Defects (NEXPEDE-1) (NEXPEDE-1)
The clear layer at the front of the eye that covers the pupil and iris (colored part of the eye) is called the “cornea”. When the cornea is damaged, it normally heals within a few days but it may take up to 2 weeks depending on the size and depth of the defect (wound). Some corneal defects heal much slower than expected. A defect in the cornea that fails to heal within the normal time of 2 weeks despite using the best available medicines and procedures, is known as Persistent Corneal Epithelial Defect (or PCED for short). The purpose of this research study is to evaluate the safety, tolerability, and effectiveness (risks and benefits) of of NEXAGON ophthalmic gel for the treatment of PCEDs.
• at least 2 years old
• diagnosis of Persistent Corneal Epithelial Defect (PCED) for at least 2 weeks that hasn't responded to one or more conventional non-surgical treatments
• active eye infection that requires treatment
• additional eye conditions that exclude study participation (study staff will review)
MT2016-11 :Autologous Stem Cell Transplant In Patients with Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL)
The treatment (chemotherapy and transplant procedures) is considered standard clinical care that are usually given to the patients with this disease. The research aspect of this study is to collect data on the patients who are being treated on this plan. Patients will be followed throughout the course of their clinical care and for three years after their transplant.
• up to 75 years of age
• diagnosis of Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Mature B cell Lymphoma, or Mature T cell Lymphoma
• at least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete criteria
• women who are pregnant or breastfeeding
• chemotherapy resistant disease
• unrelated active infection
CONQUER Protocol Number 001: COllaborative, National QUality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients (CONQUER)
The purpose of this study is to develop a cohort of patients with early scleroderma, and to collect data on clinical outcomes, radiological tests, laboratory tests and to obtain biological specimens for testing.We hope to explore medical care and the impact of SSc on patients' daily lives through various questionnaires that will be collected during study participation. By looking at all of the areas mentioned, we hope to find out information about SSc that will help treat future patients, develop new treatments, and work towards a cure.
Assessing Usability of Tools to Access Pericardial Space in Simulator
This study is designed to assess the usability of tools to access the pericardial space for delivery of conductive pacing leads to the pericardium using a modified Seldinger technique. A prototype thoracic access port tool or an EndoPath trocar will used to complete a series of short tasks involving accessing the pericardial space in a simulator doll.
A Phase I/II, Multicenter, Open-Label, Single-Dose, Dose-Ranging Study to Assess the Safety and Tolerability of ST-920, a AAV2/6 Human Alpha Galactosidase A Gene Therapy, in Subjects with Fabry Disease
The purpose of this study is to test a new drug, called ST-920, to see if it is safe and if it works to treat Fabry disease. ST-920 is a gene therapy treatment, which means that ST-920 replaces the missing or broken gene you have because you have Fabry disease, with a version or copy that works.
• at least 18 years of age
• diagnosis of Fabry disease
• one or more of the following symptoms: i) cornea verticillata, ii) acroparesthesia, iii) anhidrosis, iv) angiokeratoma
• fully vaccinated for COVID- 19 per CDC guidance
• additional requirements apply for cardiac and renal groups (study staff will review)
• history of liver disease
• current or history of use in the last six months of systemic steroids
• other significant medical & mental health diagnosis (study staff will review)
A prospective, randomized, controlled, blinded study to assess the Safety and Efficacy of the Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients.
The purpose of this study is to assess the safety and effectiveness of the Butterfly study device in reducing the symptoms that are associated with the BPH condition. Another purpose is to assess sexual function and quality of life following the use of the Butterfly study device. The Butterfly study device includes a metal (nitinol) implant that looks like a butterfly. The implant is inserted through the urethra - the tube that carries pee out of the body, and resides at the area of the prostate.
• men who are 50 to 80 years old
• symptomatic BPH
• additional criteria apply, study staff will review
• known sensitivity to Nickel
• current urinary retention
• urinary stress incontinence
• currently active bladder tumor or intravesical instillation
• additional exclusion criteria related to prostate or urinary tract function (study staff will review)
The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib
We are studying how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
• diagnosis of HER2-positive breast cancer
• received neoadjuvant (before surgery) chemotherapy
• had surgery that removed all disease in the breast and lymph nodes
• restricted from strenuous activity but can walk and do work of a light or sedentary nature, e.g., light house work, office work
• additional criteria apply (study staff will review)
• women who are pregnant or breastfeeding
• history of prior invasive breast cancer within past 3 years
• peripheral neuropathy that is more than intermittent & mild
• see link to clinicaltrials.gov for additional exclusion criteria
A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naive Metastatic Anal Cancer Patients
We are looking at the addition of nivolumab to chemotherapy compared to usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body. Immunotherapy, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells. Giving nivolumab with chemotherapy may help doctors find out if the treatment is better or the same as the usual approach.
• inoperable, recurrent, or metastatic anal cancer
• restricted from strenuous activity but can walk and are able to carry out work of a light or sedentary nature
• requirements for lab results at a defined level (study staff will review)
• history of significant heart disease
• women who are pregnant or breastfeeding
• previous use of systemic chemotherapy or other investigational drugs
• prior immunotherapy
• active autoimmune disease or history of autoimmune disease
• other primary cancer within the last 3 years
• intermittent peripheral neuropathy
• additional exclusion criteria that study study will review
A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients with Locally Advanced or Metastatic Solid Tumours
This is an early study of a new drug, called [225Ac]-FPI-1434, to treat solid tumors that have not responded to usual treatment. We are testing different doses of the drug and looking at how well it works for treating the cancer and side effects that occur.
• advanced solid tumor that is refractory to all standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy
• restricted in strenuous activity but can walk and is able to do light work e.g., light house work, office work
• contact study staff for additional requirements
• inability to perform the required imaging procedures (e.g., inability to lay flat during scan time)
• uncontrolled brain metastasis
• history of organ transplantation, including stem cell transplantation
• other significant medical or mental health diagnosis (study staff will review)
Tissue biopsies for the study of FSHD
A single visit study with muscle and/or skin biopsy / blood draw, performed to determine whether a molecular or cellular defect can be attributed to cells of Fascioscapulohumeral Muscular Dystrophy (FSHD) muscle. This study is recruiting both individuals with genetically confirmed FSHD as well as unaffected healthy (control) individuals.
• Genetic confirmation of Fascioscapulohumeral Muscular Dystrophy (FSHD)
• at least 4 years old
• Healthy Family Members: parent or sibling of someone who has FSHD
• heart failure, respiratory insufficiency that requires respiratory support
• taking anticoagulants or anti platelet medications (aspirin or NSAIDs)
Circuit-Based Deep Brain Stimulation for Parkinsons disease; Udall Project 1 Aim 2 and 3
Study objectives: -To characterize spontaneous and movement-related LFP changes in STN and GP in externalized patients under conditions that modulates the severity of tremor, bradykinesia and rigidity (off meds/off stim; on meds/off stim; off meds/on stim, on meds/on stim). -To characterize and compare the relative effect of different forms of closed loop stimulation (e.g., triggered at specific thresholds of low beta/HFO PAC or beta band activity) to standard isochronal high frequency DBS on motor signs and performance during movement.
• diagnosis of idiopathic Parkinson's Disease
• DBS surgery or battery replacement at UMN is planned as part of routine clinical care
• other significant neurological disorder
• history of dementia
• history of stereotactic neurosurgery
• people who have post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety
• women who are pregnant
Autonomic and Vascular Mechanisms of Cardiovascular Risk in Women with Post-traumatic Stress-Disorder (PTSD)
Having PTSD is associated with a higher risk of developing Cardiovascular Disease (CVD), which presents a major health risk for women, who are twice as likely as men to develop PTSD. The purpose of this study is to learn more about the mechanisms behind the relationship between PTSD and increased cardiovascular risk. Ultimately, our goal is to use the knowledge gained from this research study to help develop intervention and treatment strategies to protect the cardiovascular health of women with PTSD.
• female
• 18 years and older
• pre-menopausal
• must have experienced a past trauma, with or without PTSD Diagnosis
• pregnant or breastfeeding
• severe traumatic brain injury
• hypertension
• diabetes
• heart disease
• vascular disease
• illicit drug use within the past 6-months prior to participation
• inability or unwillingness to abstain from nicotine use for at least 12 hours prior to Study Visits 2 & 3
Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation. (HERMES)
We are looking at a new drug called 'ziltivekimab' to see if it can be used to treat people living with heart failure and inflammation. People will get either ziltivekimab or a placebo (inactive dummy drug). The study drug is an injection given into the fold of the skin on the stomach, thigh or upper arm once every month. People will take the study drug for up to 4 years.
• at least 18 years old
• diagnosis of heart failure
• hospitalization or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous diuretic treatment, within the last 9 months prior to starting the study
• left ventricular ejection fraction (LVEF) greater than 40% documented by echocardiogram in the past year
• contact study staff for additional requirements
• myocardial infarction, stroke, unstable angina pectoris, transient ischemic attack, or heart failure hospitalization within 30 days
• planned cardiac procedures (ablation, revascularization
• primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD etc.)
• women who are pregnant, breast-feeding or planning to get pregnant during the study period.
• contact study staff for additional exclusion criteria
Stability 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs Quad Tendon (Protocol # PRO19020231) (STABILITY 2)
The purpose of this multicenter study is to compare outcomes between patients who will undergo different types of ACL reconstruction. All patients will have a tendon from their own knee used to reconstruct the ACL. Prior to knee surgery, researchers will randomize (i.e. a coin toss) to determine if ACL reconstruction will be done with patellar or quadriceps tendon and if the lateral extra-articular tenodesis will or will not be added to the ACL surgery. We will follow-up with participants as they undergo treatment and recovery after surgery for 2 years.
• age 14-25
• ACL deficient knee
• at least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity
• previous ACL repair on either knee
• partial ACL tear
• multiple ligament injury (two or more ligaments requiring surgery)
• pregnancy
NRG-BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma
We are looking at adding lomustine to temozolomide and radiation therapy when compared to temozolomide and radiation therapy alone (usual care). We will compare the effect (shrinking or stabilizing) and side effects when treating newly diagnosed MGMT methylated glioblastoma. Each of the drugs and radiation work in a different way to stop the growth of tumor cells.
• 18 to 70 years old
• no known IDH mutation
• must consent and have tumor submitted within 30 days of surgery
• adequate hematologic, kidney, and liver function (study staff will review)
• previous treatment of the brain tumor
• prior cancer (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
• women who are pregnant or breast feeding