Education and Training

  • G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer

    This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer.

    The study is an open-label design, consisting of 3 parts: dose-finding portion including food effect (Part 1), G1T48 monotherapy expansion portion (Part 2), and G1T48 in combination with palbociclib expansion portion (Part 3). All parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 184 patients may be enrolled in the study.

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  • On-Line Intervention to Lower Cardiovascular Risk in Pediatric Heart Transplant Patients

    Pediatric heart transplant patients have a high-risk cardiovascular profile affecting their long-term outcomes and survival. Currently, no effective cardiovascular preventative care is provided for this pediatric population, in part, due to the fact that clinic-based programs are not easily accessible to children and their families. However, tele-health has been show to improve medical outcomes by making care more accessible to these patients. This study aims to meet the urgent need for an effective and sustainable delivery of preventative care to pediatric heart transplant patients using a diet and exercise intervention program delivered live over the internet direct to these patients' homes.

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  • Management of Insomnia in Breast Cancer Patients

    To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified).

    Participants will be randomized into 4 groups:

    - Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day.

    - Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day.

    - Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention.

    - Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.

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  • Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer

    RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.

    PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.

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  • LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib

    A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator

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  • Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (EMERGE-201)

    This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.

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  • KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment

    This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.

    This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time.

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  • Global Registry for Endovascular Aortic Treatment (GREAT)

    Prospective, observational Registry to obtain data on device performance and clinical outcomes.

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  • Mogamulizumab Q4week Dosing in Participants With R/R CTCL

    This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of mogamulizumab given Q4W following initial weekly induction in adult participants with relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening Period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from Cycle 1 Day 1.

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  • Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome

    The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.

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  • High Dose Steroid Therapy to Treat Flares in Patients With Inflammatory Bowel Disease (IBD)

    This study will examine whether delivery of high dose steroids, directly into the inflamed bowel via its arterial blood supply, will be better for treating uncontrolled flares of inflammatory bowel disease in patients compared to conventional intra-venous or oral administration of this drug. Patients aged 4-25 years of age will be recruited.

    In this study, we hope to also learn how this directed steroid delivery during an active flare will improve patient symptoms as well as the appearance of inflamed segments of bowel determined by imaging or biopsy (i.e. at the time of endoscopy). Additional data will determine how the blood vessels in the bowel affect, and potentially even drive the mechanisms, of inflammatory bowel disease.

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  • Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial

    The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.

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  • Lymphedema Study for Arm or Leg Lymphedema

    This study compares the effectiveness of a study drug versus placebo in the treatment of lymphedema.

    Investigator

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  • Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome

    RATIONALE: Lenalidomide may stop the growth of mycosis fungoides/Sezary syndrome by blocking blood flow to the cancer.

    PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with relapsed mycosis fungoides/Sezary syndrome.

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  • Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)

    To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

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  • Internet Diabetes Self-Management Workshop

    The purpose of this study is to determine of the effectiveness of an Internet based Diabetes Self-Management workshop for people with type II diabetes. Half of the people who complete the workshop will be invited to continue their education by participating in a email discussion group. Thus, we will be able to learn both the efficacy of the original program as well as its efficacy when reinforced by the discussion group.

    Diabetes is a disease that must be managed day by day by the individual with the disease. Although we know a great deal about the self-management of type II diabetes, most self-management is less than optimal. In addition, most people with diabetes do not have an opportunity to participate in formal diabetes education. This study will determine if an Internet delivered educational workshop will help people with diabetes manage their disease. Thus we will be measuring changes in behaviors, changes in symptoms and changes in HbA1c, blood pressure, cholesterol, and weight. If successful the workshop will serve as a prototype for Internet diabetes education.

    Investigator

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  • hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma

    RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein work in different ways to stimulate the immune system and stop tumor cells from growing.

    PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works in treating young patients with recurrent or refractory neuroblastoma.

    Investigators

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  • MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma

    Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with a primary invasive cutaneous melanomas >=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients

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  • Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol

    This is an expanded access protocol that will be conducted at sites qualified and approved to treat subjects with lisocabtagene maraleucel. Sometimes when lisocabtagene maraleucel is manufactured the drug does not pass all the testing results to be called lisocabtagene maraleucel. When this happens the drug is called nonconforming lisocabtagene maraleucel. The expanded access protocol will be used to allow subjects to receive nonconforming lisocabtagene maraleucel only if the potential benefit is better than the potential risk. This expanded access protocol is restricted to those subjects who were prescribed lisocabtagene maraleucel as part of their routine care.

    Subjects will first receive a lymphodepleting chemotherapy regimen and then be treated with nonconforming lisocabtagene maraleucel as the treatment plan.

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  • Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis

    The purpose of this study is to understand the effect that T helper 2 (Th2) blockade has on well-described pathophysiological features of Atopic Dermatitis (AD), for example: barrier, epidermal activation, dysbiosis and epidermal lipids.

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