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ProtocolTrial Name and Objective
051403

A first-in-human phase I single-agent open-label dose-escalation study of every three-week dosing of oral ONC201 in patients with advanced solid tumors

Dose escalation:
To determine the recommended maximal tolerated dose (MTD) or recommended phase II dose of single agent ONC201 orally once every three weeks

Dose expansion:
To characterize the safety and tolerability of ONC201 in patients with tumors that have a high frequency of PI3 kinase pathway or RAS signaling activation (metastatic castrate resistant prostate cancer, metastatic renal cell carcinoma, melanoma, glioblastoma multiforme, breast cancer).
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131213

Sun Protection and Skin Surveillance: Beliefs and Behaviors of Childhood Cancer Survivors

To establish the prevalence and correlates of skin cancer prevention and surveillance behaviors among CCS using depth interviews and survey research.
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131306

Tailored Intervention for Melanoma Patients' Families

The primary aim is to evaluate the impact of an enhanced tailored internet intervention (Skin TII) versus the previously evaluated tailored print and phone counseling (TPC) on the engagement in TCE, the thoroughness of SSE, and the sun protection habits of FDRs at increased risk for melanoma.

The secondary aim is to determine whether behavioral intentions, SSE self-efficacy, and sunscreen self-efficacy mediate the expected association between the interventions and TCE, SSE thoroughness, and sun protection, with stronger effects for Skin TII. We do not expect benefits and barriers to mediate treatment effects, but we will explore these as possible mediators in our analyses.
The exploratory aim is to evaluate whether user characteristics (Internet usage, internet experience, learning style, internet self-efficacy) and health care access (insurance status, distance from a dermatologist) moderate the expected associations between the Skin TII and outcomes and evaluate the perception, perceived impact, usability, and barriers of use of the Skin TII intervention. We will also evaluate the cost effectiveness of each intervention.
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131315

The Development and Evaluation of a Behavioral Intervention to Reduce Indoor Tanning

1.1 Primary Objective

Phase 1a-c: To use a series of three qualitative research studies to inform the development of an indoor tanning intervention.

Phase 2: To develop and evaluate an online tailored IT intervention based on findings from Phase 1.

1.2 Specific Aims

Aim 1 (Phase 1a): To use key informant interviews to produce an ethnographic description of the IT culture and associated language and concepts based on key informant interviews with IT users.

Aim 2 (Phase 1b): To use long interviews with IT users in order to examine the importance of the proposed SRT constructs.

Aim 3 (Phase 1c): To use focus groups to explore a range of experiences related to the SRT constructs among IT users as well as differences in perceptions of these factors.

Aim 4 (Phase 2): To determine if the intervention is feasible and acceptable to participants.

Aim 5 (Phase 2): To analyze preliminary outcome data in terms of the effectiveness of the intervention in reducing IT behaviors among participants compared to control participants.
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051510

Phase I Study of Intratumoral CAVATAK (Coxsackievirus A21) and Pembrolizumab in Patients with Advanced Melanoma

2.1. Primary Objective

To assess the safety and tolerability of intravenous pembrolizumab with in combination with Intratumoral CAVATAK by incidence of dose-limiting toxicities (DLT).

2.2. Secondary Objectives

1. To assess the clinical efficacy of Pembrolizumab with in combination with Intratumoral CAVATAK in terms of of immune-related progression-free survival (irPFS) at 12 months, PFS hazard ratio, objective response rate (ORR), 1-year survival, overall survival (OS) and quality of life.
2. Assess the response of injected and non-injected melanoma deposits after CAVATAK and pembrolizumab.
3. Assess the time to initial response
4. Assess durable response rate at 6 months.
5. Assess peripheral blood for changes in T-cell phenotypes after CAVATAK and pembrolizumab.
6. Assess for T-cell immune response to known melanoma antigens during treatment.
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091201

A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients with a High Risk of Recurrence

Part A Objectives
␣ To evaluate the safety of POL-103A in patients with stage IIB, IIC, or III melanoma. ␣ To evaluate the biological activity of POL-103A in patients with stage IIB, IIC, or III
melanoma. ␣ To select the dose for Part B. ␣ To collect blood samples for the future investigation of the sustained biologic activity
of POL-103A.
Part B Objectives Primary Objective
␣ To assess the efficacy of treatment with POL-103A compared to placebo with respect to recurrence-free survival or overall survival
Secondary Objectives
2.2 2.2.1
2.2.2
␣ To verify the safety and tolerability of POL-103A at the dose selected for Part B.
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091309

A Phase II Single Arm Study of High-Dose IL-2 and Ipilimumab in Patients with Unresectable Stage III and Stage IV Melanoma

1.The combination of Ipilimumab and high-dose IL-2 improves clinical responses.
2.The combination of Ipilimumab and high-dose IL-2 is feasible and has an acceptable safety profile.
3.The combination of Ipilimumab and high-dose IL-2 results in increased effector CD8+ T cells and decreased CD4+FoxP3+ regulatory T cells in responding patients.
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051306

A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0010718C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications.

To assess the safety and tolerability of MSB0010718C and to determine the maximum tolerated dose (MTD) of MSB0010718C in subjects with metastatic or locally advanced solid tumors.
Secondary objectives
- To characterize the pharmacokinetic (PK) profile of MSB0010718C and to correlate exposure with target occupancy.
- To evaluate the immunogenicity of MSB0010718C and to correlate it to exposure
and biological activity.
- To assess the best overall response (BOR) andprogression-free survival time (PFS) according to Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1.
- To assess the immune-related BOR (irBOR) and immune-related PFS (irPFS) using the modified Immune-Related Response Criteria (irRC),
derived from RECIST 1.1.
- To assess overall survival time (OS).
- To evaluate biological responses to MSB0010718C in blood/serum.
- To evaluate the association between tumor programmed death ligand 1 (PD-L1) expression and BOR.
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051405

A Phase I Study of the Clinical and Immunologic Effects of ALT-803, a Novel Recombinant IL-15 Complex, in Patients with Advanced Melanoma

Primary Objectives: (1) to study the safety of escalating doses of ALT-803 in patients with advanced melanoma and screen the selected dose in an expansion cohort for evidence of antitumor activity. (2) to evaluate the effect of escalating doses of ALT-803 on the peripheral blood white blood cell (WBC) and absolute lymphocyte (ALC) counts.
Secondary Objectives: To evaluate the effect of escalating doses of ALT-803 on: (1) the number and phenotype of peripheral blood mononuclear cells (PBMCs), including T and natrual killer (NK) cells by multiparameter flow cytometry. (2) the level of immune response to autochthonous viral and tumor antigens by interferon-gamma ELISPOT. (3) immunogenicity and pharmacokinetics of ALT-803. (4) overall objective response rate (ORR) and response duration.
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111505

CHILDREN'S ONCOLOGY GROUP AHOD1331: A Randomized Phase III Study of Brentuximab Vedotin (SGN-35, IND #117117) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents.

1. To assess the event free survival (EFS) of a novel regimen incorporating brentuximab vedotin (Bv; AdcetrisTM) in the chemotherapy backbone of doxorubicin (Adriamycin), vincristine, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) in newly diagnosed high-risk cHL compared to those treated with ABVE-PC.
2. To determine whether children/adolescents with high-risk cHL treated with Bv-AVEPC have a higher rate of early response (determined by FDG-PET) and a reduction in response-directed radiation therapy (RT) compared to those treated with ABVE-PC.
3. To compare the rate of neuropathy (> Grade 3) among patients treated on the Bv-AVEPC (experimental arm) to patients treated on the ABVE-PC (standard arm).
4. To validate and compare the Childhood Hodgkin International Prognostic Score (CHIPS) to conventional Ann Arbor Stage (Stages II B with bulk, III B, IV A or B) in predicting outcome in high-risk childhood cHL.
Biology
5. To determine the incidence of preferentially expressed antigen in melanoma (PRAME) and testis-specific antigens in EBV- cHL tumors and the incidence of EBV antigens (EBNA1, LMP1, LMP2) in EBV+ cHL tumors, with the goal of developing strategies to integrate cellular therapy into treatment for newly diagnosed high-risk cHL.
6. To incorporate qualitative visual FDG-PET into response-directed treatment algorithms and explore quantitative FDG-PET and CT definitions of tumor burden and response for incorporation into next generation pediatric cHL risk-stratification schemes.
7. To evaluate the reduction in normal tissue irradiation associated with the current treatment approach compared to the volume of historic IFRT fields.
8. To evaluate EFS and patterns of relapse following protocol-specified RT utilization and treatment volumes.
Patient Reported Outcomes (PRO) of Peripheral Neuropathy and Health-Related Quality of Life
9. To characterize the extent of chemotherapy induced peripheral neuropathy (CIPN), as reported by patients and parent proxies, through serial administration of the FACT-GOG-NTX.
10.To describe the Health-Related Quality of Life (HRQL) consequences of peripheral neuropathy over time by correlating total neuropathy scale scores with the individual items with the CHRIs-Global scale (e.g., physical health, pain, emotional functioning).
11.To perform a cross validation of the FACT-GOG-NTX with the TNS-PV to determine the performance of both measures with the use of brentuximab vedotin in a limited institutional approach in children and adolescents with cHL
12.To assess the resource use and cost implications of Bv in combination with chemotherapy and radiotherapy (RT) for newly diagnosed high-risk cHL in children and adolescents
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131316

Project SOL - Sun Safety for Outdoor Laborers

The goal of this project is to develop and test a culturally relevant sun safety education program for the Hispanic outdoor day laborer population who work or reside in the Greater New Brunswick (New Jersey) area. Although little is known about the incidence of skin cancer among Hispanic outdoor day laborers, ultraviolet radiation (UVR) exposure is a key risk factor for both
melanoma and non-melanoma skin cancers, and outdoor day laborers spend a large amount of their work exposed to UVR. The incidence of melanoma has steadily increased among U.S. Hispanics in recent years.
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131403

Internet Intervention for Sun Protection and Skin Self-Check Behaviors

The overall purpose of this project is to develop and test a web-based intervention to promote skin self-examination (SSE) and sun protection behaviors among individuals diagnosed with melanoma.

Individuals diagnosed with melanoma are at increased risk for second primary melanoma and disease recurrence, and it is recommended that they periodically receive a total cutaneous examination (TCE) from a physician, perform a regular SSE, and routinely engage in sun protection behaviors.1 Although patients typically have a periodic TCE, our previous research suggests that more than two-thirds of them do not perform a thorough, full-body SSE on a sufficiently regular basis.2 We have also found that many patients fail to engage in one or more sun protection behaviors.3 There is a critical need to develop effective interventions to promote SSE and sun protection behaviors among melanoma patients. In the proposed research, we will develop and test an innovative web-based intervention to promote skin surveillance and sun protection behaviors among melanoma patients.

The project will be conducted in two phases. Phase 1 focuses on intervention development, usability testing, and refinement. In Phase 2, we will conduct a randomized controlled trial (RCT) comparing the efficacy of an interactive tailored website (ITW) versus Usual Care in promoting SSE and sun protection behaviors among melanoma patients who completed surgical treatment from 3'24 months previously.
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