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About 51,523 results

De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer
https://clinicaltrials.gov/ct2/show/NCT03952585

Jan 27th, 2023 - PRIMARY OBJECTIVES: I. To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin). (Phase II) II. To demonstrate co-primary endpoints of non-inferiority of PFS and superiority of quality of ...

Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma
https://clinicaltrials.gov/ct2/show/NCT02947607

Jan 27th, 2023 - The purpose of this study is the investigation of new host-microbiome interactions promoting adenoma formation and adenocarcinoma progression. For that purpose, the investigators will collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or surgical resection of colorectal tumor. Besides, a questionnaire about diet, lifestyle and medical history will be collecte...

A Longitudinal Observational Study of the Natural History and Management of Patients With HCC
https://clinicaltrials.gov/ct2/show/NCT02954094

Jan 27th, 2023 - TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual clinical practice. TARGET-HCC will create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.

Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer
https://clinicaltrials.gov/ct2/show/NCT04675710

Jan 27th, 2023 - PRIMARY OBJECTIVES: I. Demonstrate the efficacy of upfront treatment with neoadjuvant pembrolizumab in combination dabrafenib and trametinib by comparing the complete gross surgical resection rate (R0 or R1 surgical resection) to historical control of 5%. II. Demonstrate the efficacy of pembrolizumab in combination with dabrafenib and trametinib by comparing the overall survival (OS) to histori...

A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma
https://clinicaltrials.gov/ct2/show/NCT04576117

Jan 27th, 2023 - PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of selumetinib sulfate (selumetinib) + vinblastine sulfate (vinblastine) for children with progressive or recurrent low-grade gliomas (LGGs). II. To determine if selumetinib + vinblastine will lead to improved event-free survival (EFS) outcome compared with selumetinib alone for children with prog...

Corticotrophin-releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing s Disease
https://clinicaltrials.gov/ct2/show/NCT04569591

Jan 27th, 2023 - This study is designed as a single institution trial. The study utilizes safe and clinically-validated tools for preoperative workup of patients with small pituitary tumors. CRH stimulation and 18F-FDG uptake in PET imaging will be used to detect MRI-negative pituitary adenomas in patients with Cushing s disease. Patients who have MRI-negative pituitary microadenomas will undergo 18F-FDG PET-im...

Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck Cancer
https://clinicaltrials.gov/ct2/show/NCT01711541

Jan 27th, 2023 - PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD), recommended phase II dose, dose limiting toxicity (DLT), and safety of ABT-888 (veliparib) with carboplatin and paclitaxel induction chemotherapy in locoregionally advanced head and neck (LAHNC) patients. (Phase I) II. Compare magnitude of tumor shrinkage (response) following 2 cycles of induction chemotherapy with and without A...

Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin
https://clinicaltrials.gov/ct2/show/NCT03161132

Jan 27th, 2023 - The combination of Poly (ADP-ribose) polymerase (PARP) inhibitors with PLD may provide a synergistic effect in patients with advanced ovarian cancer, especially those with Homologous recombination deficiency (HRD), because of the decreased ability to repair chemotherapy-induced DNA damage. Preclinical studies with PARP inhibitors have shown potentiation of the cytotoxic effects of chemotherapeu...

Intermittent Therapy in Metastatic Renal Cell Carcinoma Patients Treated With Ipilimumab and Nivolumab
https://clinicaltrials.gov/ct2/show/NCT03126331

Jan 27th, 2023 - Primary Objective: - To determine the feasibility of intermittent nivolumab therapy in patients with metastatic renal cell carcinoma. Secondary Objectives: To determine the clinical outcome (overall response rate (ORR), progressive free survival (PFS), overall survival (OS)) in metastatic renal cell carcinoma patients treated with intermittent nivolumab therapy. To evaluate the toxicity of inte...

Vincristine and Temozolomide in Combination With PEN-866 for Adolescents and Young Adults With Relapsed or Refractory Solid Tumors
https://clinicaltrials.gov/ct2/show/NCT04890093

Jan 27th, 2023 - Background: Irinotecan is a prodrug of an inhibitor of topoisomerase 1 (active metabolite is SN-38) with known activity in sarcomas, however it has limitations including suboptimal bioavailability and systemic side effects including severe diarrhea and bone marrow suppression. Preclinical and clinical evidence has demonstrated that prolonged exposure to topoisomerase 1 inhibition produces super...

Vaccine Response With NT-I7
https://clinicaltrials.gov/ct2/show/NCT04054752

Jan 27th, 2023 - Background: Interleukin-7 is a homeostatic cytokine with a critical role in lymphoid homeostasis through which it exerts its immune-restorative effects, particularly re-expansion of the na(SqrRoot) ve and memory T-cell subsets. The clinical implications of the kinetics, nature and extent of immune reconstitution defects following standard or ablative chemotherapy in older adults with cancer (in...

Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission
https://clinicaltrials.gov/ct2/show/NCT01586260

Jan 27th, 2023 - The purpose of this research study is to evaluate a new investigational drug to prevent reoccurrence of neuroblastoma that is in remission. This study drug is called DFMO. The objectives of this study will be to monitor for safety and look at efficacy of DFMO. The safety of the proposed dosing regimen in this trial will be tested by an on-going risk/benefit assessment during the study. A patien...

Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors
https://clinicaltrials.gov/ct2/show/NCT04074135

Jan 27th, 2023 - Background: Patients with the von Hippel-Lindau (VHL) familial cancer syndrome demonstrate manifestations in a variety of organs, including the pancreas. Pancreatic manifestations can range from benign cysts and micro cystic adenomas to neuroendocrine tumors of the pancreas which are capable of regional and distant metastases. These neuroendocrine tumors can result in life-threatening complicat...

A Dose Escalation Study to Estimate MTD, DLTs and Pharmacokinetics After a Single Intracranial Dose of SI-053 as an add-on to the Current Standard of Care, in Adult Patients With Newly Diagnosed GBM
https://clinicaltrials.gov/ct2/show/NCT04967690

Jan 27th, 2023 - SI-053 is a novel powder formulation containing temozolomide (TMZ), an alkylating chemotherapy agent, in an excipient which forms a viscous gel upon reconstitution in water. SI-053 will be used as an add-on to SoC for newly diagnosed GBM. SoC consists of maximal safe resection followed by radiation therapy (RT) with concomitant TMZ and adjuvant chemotherapy with TMZ. For MGMT promoter methylate...

Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
https://clinicaltrials.gov/ct2/show/NCT04077372

Jan 27th, 2023 - Primary Objective: To determine whether the Serious Illness Conversation Guide will improve the consistency with which providers have and document conversations regarding patients' goals and priorities as they near the end of life. Secondary Objectives: 1. To assess whether having conversations as per this model will improve the quality of care near the end of life as determined by appropriate ...

BrUOG 354 Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas
https://clinicaltrials.gov/ct2/show/NCT03355976

Jan 27th, 2023 - Preclinical and early-phase clinical data suggest that immune modulation represents a treatment strategy that is worthy of further investigation in relapsed epithelial ovarian cancer. One method by which tumor cells may evade immune surveillance is by activation of the programmed cell death (PD-1) pathway, mediated by expression of PD-1 on the surface of T lymphocytes, which conveys an inhibito...

A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
https://clinicaltrials.gov/ct2/show/NCT04166409

Jan 27th, 2023 - PRIMARY OBJECTIVE: I. To demonstrate that the efficacy of treatment with selumetinib as measured by event-free survival (EFS) is non-inferior compared to treatment with carboplatin/vincristine (CV) in previously-untreated low-grade glioma (LGG) not associated with BRAFV600E mutations or systemic neurofibromatosis type 1 (NF1). SECONDARY OBJECTIVES: I. To estimate tumor response rates to each re...

A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden
https://clinicaltrials.gov/ct2/show/NCT04145115

Jan 27th, 2023 - PRIMARY OBJECTIVE: I. To determine whether the combination of ipilimumab and nivolumab increases the tumor response rate assessed by modified Response Assessment in Neuro-Oncology (RANO) Criteria in patients with hypermutated recurrent glioblastoma. SECONDARY OBJECTIVES: I. Estimate the overall survival distribution, median survival, and one-year survival rate of patients with hypermutated, rec...

Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors
https://clinicaltrials.gov/ct2/show/NCT02379416

Jan 27th, 2023 - Background: -The BCR-Abl kinase inhibitor nilotinib demonstrated greater than additive activity in combination with the anti-tubulin agent paclitaxel in preclinical xenograft models, justifying the clinical evaluation of this combination for its antitumor activity Objectives: To establish the safety, tolerability, and maximum tolerated dose (MTD) of nilotinib plus paclitaxel in patients with re...

Study of MEK162 for Children With Low-Grade Gliomas
https://clinicaltrials.gov/ct2/show/NCT02285439

Jan 27th, 2023 - PROTOCOL SUMMARY: Phase 1: Patients with non-hematologic malignancies that are recurrent, progressive, or refractory after standard up-front therapy receiving MEK162 will define the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and toxicity profile. Phase 2: Patients with recurrent or progressive tumors signaling through the ras/raf pathway after standard up-front therapy will b...