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14 result(s) found

Amyloidosis


A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis 

This is a double-blind, randomized, multicenter international Phase 3 study of CAEL-101 combined with standard of care plasma cell dyscrasia (PCD) treatment versus placebo combined with standard of care PCD treatment in Mayo stage IIIb PCD treatment-naïve AL amyloidosis patients. The minimum planned treatment time for each patient will be at least 50 weeks or until the patient’s death. It is planned that all patients will continue their double-blind treatment until the last patient completes at least 50 weeks of treatment. As this is an event-driven study, the study will continue, and all patients will continue to receive study treatment until at least 54 deaths have been observed. Approximately 111 patients will be enrolled using a 2:1 randomization ratio. Stratification will be based on geographic region across approximately 70 investigator sites. 

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CAEL 101-302: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell DyscrasiaTreatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis

This is a double-blind, randomized, multicenter international Phase 3 study of CAEL-101 combined with standard of care plasma cell dyscrasia (PCD) treatment versus placebo combined with standard of care PCD treatment in Mayo stage IIIa PCD treatment-naïve AL amyloidosis patients. The minimum planned treatment time for each patient will be at least 50 weeks or until the patient’s death. It is planned that all patients will continue their double-blind treatment until the last patient completes at least 50 weeks of treatment. As this is an event-driven study, the study will continue, and all patients will continue to receive study treatment until at least 77 deaths have been observed. Approximately 267 patients will be enrolled using a 2:1 randomization ratio. Stratification will be based on geographic region across approximately 70 investigator sites.

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Brain Tumors


A Phase III Trial Of Stereotactic Radiosurgery Compared With Whole Brain Radiotherapy (WBRT) For 5-15 Brain Metastases

This is an international multi-centre, open-label, randomized phase III trial comparing stereotactic radiosurgery (SRS) to whole brain radiotherapy (WBRT) in patients with 5 to 15 brain metastases.

Primary Objectives

• To compare the overall survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive WBRT.

• To compare the neurocognitive progression-free survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive WBRT.

 

Secondary Objectives

Patient/treatment Related Secondary Outcomes

• To compare time to central nervous system (CNS) failure (local, distant, and leptomeningeal) in patients who receive SRS compared to patients who receive WBRT.

• To evaluate if there is any difference in CNS failure patterns (local, distant, or leptomeningeal) in patients who receive SRS compared to patients who receive WBRT.

• To evaluate number of salvage procedures following SRS in comparison to WBRT.

• To evaluate the individual cognitive test results following SRS in comparison to WBRT.

• To tabulate and descriptively compare the post-treatment adverse events associated with the interventions.

• To evaluate the time delay to (re-)initiation of systemic therapy in patients receiving SRS in comparison to WBRT.

• To prospectively validate a predictive nomogram for distant brain failure [Ayala-Peacock 2014].

Economic Endpoints

• To compare the estimated cost of brain-related therapies in patients who receive SRS compared to patients who receive WBRT:

- Comparison based on payer rates (Medicare for US / provincial heath authorities in Canadian jurisdictions with activity-based funding).

Quality of Life Endpoints

• To evaluate patient’s quality of life, as assessed by the EORTC QLQ-C30 + BN20, EQ-5D, ECOG performance status, for those who receive SRS compared to those who receive WBRT.

Translational Endpoints

• Collect plasma to evaluate whether detectable somatic mutations in liquid biopsy can enhance prediction of the overall survival and development of new brain metastases.

• Analysis of serum samples for inflammatory biomarker C-reactive protein and brain-derived-neurotrophic factor (BDNF) to elucidate molecular/genomic mechanisms of neurocognitive decline and associated radiographic changes.

Imaging/Dosimetric Endpoints

• Collect whole-brain dosimetry in SRS patients to be prospectively correlated with cognitive toxicity, intracranial control and radiation necrosis (hippocampal dosimetry will be retrospectively assessed).

• Collect imaging parameters and workflow details relating to the radiosurgery planning MRIs (including timing of MR prior to radiosurgery, magnet field strength, contrast type/dose/timing, use of image post-processing, and formal reviewed by radiology) to be prospectively correlated with tumour control outcomes (local control, intracranial control).

• Evaluate serial changes in imaging features found in routine MRI images (T2w changes, morphometry) that may predict tumour control and/or neurocognitive outcomes

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Breast Cancer


A Phase III Trial Of Stereotactic Radiosurgery Compared With Whole Brain Radiotherapy (WBRT) For 5-15 Brain Metastases

This is an international multi-centre, open-label, randomized phase III trial comparing stereotactic radiosurgery (SRS) to whole brain radiotherapy (WBRT) in patients with 5 to 15 brain metastases.

Primary Objectives

• To compare the overall survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive WBRT.

• To compare the neurocognitive progression-free survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive WBRT.

 

Secondary Objectives

Patient/treatment Related Secondary Outcomes

• To compare time to central nervous system (CNS) failure (local, distant, and leptomeningeal) in patients who receive SRS compared to patients who receive WBRT.

• To evaluate if there is any difference in CNS failure patterns (local, distant, or leptomeningeal) in patients who receive SRS compared to patients who receive WBRT.

• To evaluate number of salvage procedures following SRS in comparison to WBRT.

• To evaluate the individual cognitive test results following SRS in comparison to WBRT.

• To tabulate and descriptively compare the post-treatment adverse events associated with the interventions.

• To evaluate the time delay to (re-)initiation of systemic therapy in patients receiving SRS in comparison to WBRT.

• To prospectively validate a predictive nomogram for distant brain failure [Ayala-Peacock 2014].

Economic Endpoints

• To compare the estimated cost of brain-related therapies in patients who receive SRS compared to patients who receive WBRT:

- Comparison based on payer rates (Medicare for US / provincial heath authorities in Canadian jurisdictions with activity-based funding).

Quality of Life Endpoints

• To evaluate patient’s quality of life, as assessed by the EORTC QLQ-C30 + BN20, EQ-5D, ECOG performance status, for those who receive SRS compared to those who receive WBRT.

Translational Endpoints

• Collect plasma to evaluate whether detectable somatic mutations in liquid biopsy can enhance prediction of the overall survival and development of new brain metastases.

• Analysis of serum samples for inflammatory biomarker C-reactive protein and brain-derived-neurotrophic factor (BDNF) to elucidate molecular/genomic mechanisms of neurocognitive decline and associated radiographic changes.

Imaging/Dosimetric Endpoints

• Collect whole-brain dosimetry in SRS patients to be prospectively correlated with cognitive toxicity, intracranial control and radiation necrosis (hippocampal dosimetry will be retrospectively assessed).

• Collect imaging parameters and workflow details relating to the radiosurgery planning MRIs (including timing of MR prior to radiosurgery, magnet field strength, contrast type/dose/timing, use of image post-processing, and formal reviewed by radiology) to be prospectively correlated with tumour control outcomes (local control, intracranial control).

• Evaluate serial changes in imaging features found in routine MRI images (T2w changes, morphometry) that may predict tumour control and/or neurocognitive outcomes

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Cancer


A Pilot Study to Assess an Oral Anti-Cancer Medication Initiative

The use of oral anti-cancer medication to treat cancer has been increasing over time and is expected to continue to increase in the future. The use of these medicines can be challenging for patients and their families, their clinical team, and health care systems. Because these medications are administered at home, patients and their families are responsible for taking the medicines when they are supposed to, safely handling and storing the medicines, and knowing how to check for side effects. This study will ask questions to understand more about patient experiences with oral anti-cancer medication so we can develop programs to improve our support and education of patients in the future.

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Evaluating Neuropsychological and Psychological Screening in Cancer Survivors

The overall aim of this research project is to assess the feasibility and performance of neuropsychological and psychological screening measures completed by adolescents and young adults (AYA), and adults, who receive care at the Reid R. Sacco A YA Cancer Clinic or the Adult Cancer Survivorship Clinic, both at Tufts MC. The AYA Clinic provides cancer survivorship care to individuals between the ages of 18-39 years, while the Adult Clinic serves survivors ages >40. Two screening measures will be assessed: (1) the Montreal Cognitive Assessment (MOCA), a screener for mild cognitive impairment and (2) the Brief Symptom lnventory-18 (BSI), a screener for psychological distress. The results from these well-validated screeners will guide future care for these participants at Tufts MC and beyond. 

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Colorectal Cancer


Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study

This is a Phase II to Phase III randomized, double-blind, placebo-controlled design to determine if duloxetine can prevent oxaliplatin-induced peripheral neuropathy (OPIN). Initially, we will screen two duloxetine doses, 30 mg and 60 mg daily, using a 3-arm Phase II study design. The most promising dose will then be tested in a 2-arm Phase III study. The primary hypothesis in the Phase III study is that the most promising duloxetine dose will be more effective than placebo to prevent 1) sensory OIPN (N, T, & pain) during treatment and 2) chronic OIPN pain 1 month after the last planned oxaliplatin treatment.

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Craniopharyngioma


Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas

This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Head and Neck Cancer


A Randomized Double-blind Phase 3 Study Of Avelumab In Combination With Standard Of Care Chemoradiotherapy (Cisplatin Plus Definitive Radiation Therapy) Versus Standard Of Care Chemoradiotherapy In The Front-line Treatment Of Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck

This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

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Leukemia


A041702: A Randomized Phase III Study of Ibrutinib plus obinutuzumab versus ibrutinib plus venetoclax and obinutuzumab in untreated older patients (> 70 years of age) with Chronic Lymphocytic Leukemia

This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia who have not received previous treatment. The addition of venetoclax to the usual treatment might prevent chronic lymphocytic leukemia from returning. This trial also will investigate whether patients who receive ibrutinib plus obinutuzumab plus venetoclax and have no detectable chronic lymphocytic leukemia after 1 year of treatment, can stop taking ibrutinib. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.

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International Phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzyme needed for cell growth. Drugs used in chemotherapy, work in different ways to stop growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinin mesylate and combination chemotherapy may work better in treating patients with Philadelphia positive acute lymphoblastic leukemia. 

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Meningiomas


A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors In Progressive Meningiomas With SMO/AKT/ NF2 Mutations

The purpose of this study is to test good and bad effects of two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in meningioma patients. Researchers have looked at the DNA material (genes) that can be affected in meningioma and have found several genes that are altered, or mutated. These include the genes called SMO and NF2. When the SMO or NF2 genes are altered, it can cause a tumor to grow. There are drugs that target these 2 genes.

The study drug, vismodegib, blocks the SMO receptor. Vismodegib has already been FDA-approved to treat basal cell cancer, which is a type of skin cancer. Vismodegib could shrink cancer, but it could also cause side effects. The study drug, GSK22560

98, blocks FAK, and seems to work better in tumors that have NF2-mutations. GSK2256098 has been tested in other cancers. Researchers hope to learn if either of the study drugs will shrink cancer.

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Neuroblastoma


A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

This partially randomized phase III trial studies iobenguane I-131 or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or crizotinib and standard therapy may work better in treating younger patients with neuroblastoma or ganglioneuroblastoma.

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Squamous Cell Carcinoma


A Randomized Double-blind Phase 3 Study Of Avelumab In Combination With Standard Of Care Chemoradiotherapy (Cisplatin Plus Definitive Radiation Therapy) Versus Standard Of Care Chemoradiotherapy In The Front-line Treatment Of Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck

This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

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