NCI/CTEP #8850: A Phase I Trial of Riluzole and Sorafenib in Patients with Advanced Solid Tumors and Melanoma (CDUS)

The overall goal of this project is to determine if pharmacological blockade of the metabotropic glutamate receptor 1 (GRM1) signaling pathway with the agent Riluzole, combined with inhibition of RAF signaling with the agent Sorafenib, will result in clinically evident responses in patients with stage IV melanoma.
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NCI/CTEP #8983: A Phase I Trial of MK-2206 and Hydroxychloroquine in Solid Tumors, Melanoma, Renal and Prostate Cancer to Examine the Role of Autophagy in Tumorigenesis

Primary - to define the maximum tolerated dose (MTD) of MK-2206 and hydroxychloroquine (HCQ) when used in combination.
Secondary - (1) to determine the side effects and activity of MK-2206 and hydroxychloroquine when used in combination. (2) to determine if hydroychloroquine alters the pharmcokinetics of MK-2206 due to a drug-drug interaction. (3) to validate biomarkers for autophagy detection
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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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NSABP PROTOCOL B-49:A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-RiskNode-Negative, HER2-Negative Breast Cancer

Primary Aim: Aim: To determine if the docetaxel plus cyclophosphamide regimen is non-inferior to the anthracycline-based chemotherapy regimens in terms of invasive disease-free survival (IDFS) by combining B-49 data with the TAC and TC arms of NSABP B-46-I/USOR 07132 and the data from USOR 06-090.
Endpoint: IDFS, defined as time to local recurrence following mastectomy, invasive local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, invasive contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer.
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ECOG E2810: Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy

1 .To evaluate disease-free survival with pazopanib as compared to placebo, defined as the time from randomization to the development of recurrent disease, second primary cancer (other than localized breast, localized prostate, or non-melanoma skin cancer) or death from any cause for patients with metastatic RCC with no evidence of disease following metastatectomy.
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TAC113886: A Phase I Dose Escalation Open-Label, Safety, Pharmacokinetic and Pharmacodynamic Study to Determine the Recommended Phase II Dose of GSK1120212 Dosed in Combination with GSK2141795

Primary: Part 1A: To determine the safety, tolerability and recommended Phase II dose of GSK1120212 and GSK2141795 administered in combination orally, once daily continuously. Part 1B: To determine the safety, tolerability and recommended Phase II dose of GSK1120212 and GSK2141795 administered in combination with an alternate schedule (i.e., at least one agent is dosed intermittently). Part 2A, 2B: To evaluate the clinical activity of GSK1120212 and GSK2141795 administered in combination in subjects with solid tumors that are predicted to be sensitive to the inhibition of MEK and/or AKT, including TNBC and BRAF-wild type melanoma.
Secondary: (1) To characterize the PK of GSK1120212 and GSK2141795 for a once daily continuous dosing schedule (Part 1A) and/or an intermittent dosing schedule (Part 1B). (2) Part 1A, Part 1B to evaluate the clinical activity of GSK1120212 and GSK2141795 in subjects with solid tumors. (3) Parts 1 and 2, to characterize the durability of response with GSK1120212 and GSK2141795 dosed orally in combination. (4) To evaluate the pharmacodynamic (PD) response in tumors after treatment with the combination of GSK1120212 and GSK2141795. (5) To explore relationships between study drug PK, PD and clinical activity.
Translational: To explore the association of clinical and PD endpoints with genetic and protein profiles from blood and/or tumor tissue.
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ECOG E3611, A Randomized Phase II Study of Ipilimumab at 3mg/kg or 10mg/kg Alone or in Combination with High Dose Interferon-alpha in Advanced Melanoma

The purpose of this study is to compare the effects, good and/or bad, of ipilimumab (given at 2 different doses, 10 mg/kg or 3 mg/kg) either alone or in combination with interferon alfa-2b on you and your melanoma to find out which treatment is safer and better. Therefore, you will get ipilimumab (either at 10 mg/kg or 3 mg/kg) alone or in combination with interferon alfa-2b.
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Sun Protection Beliefs and Behaviors among Hispanics

The goal of this research is to identify the prevalence and correlates of skin cancer prevention and skin surveillance behaviors among Hispanics in the United States. Although Hispanics are less likely to develop skin cancer than non-Hispanic white (NHW) individuals, they have poorer outcomes after diagnosis of melanoma (the most lethal type of skin cancer), and the incidence of melanoma has steadily increased among Hispanics in recent years. Melanoma rates are highest among economically disadvantaged Hispanics, who commonly have other health care barriers. There is a dearth of research examining the prevalence and correlates of skin cancer prevention and skin surveillance behaviors among U.S. Hispanics. We will address this research gap in the project by developing and implementing a comprehensive, theory-driven, culturally relevant survey of skin cancer-related behaviors and potential correlates in a representative sample of U.S. adult Hispanics. Additionally, the project will explore the role that acculturation may play in shaping factors associated with Hispanics' engagement in skin cancer-related behaviors. The knowledge gained from this project will directly inform the development of an intervention to promote skin cancer prevention and skin surveillance behaviors among Hispanics.
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