niacinamide and Cancer of Eye studies

nicotinamide : A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group.

Research Excerpts

Excerpt	Relevance	Reference
"Sorafenib, a multikinase inhibitor of cell proliferation and angiogenesis, inhibits the mitogen-activated protein kinase pathway that is activated in most uveal melanoma tumors."	9.16	Phase II trial of sorafenib in combination with carboplatin and paclitaxel in patients with metastatic uveal melanoma: SWOG S0512. ( Aparicio, AM; Bhatia, S; Lao, CD; Margolin, KA; Moon, J; Othus, M; Ribas, A; Sondak, VK; Weber, JS, 2012)
"Sorafenib, a multikinase inhibitor of cell proliferation and angiogenesis, inhibits the mitogen-activated protein kinase pathway that is activated in most uveal melanoma tumors."	5.16	Phase II trial of sorafenib in combination with carboplatin and paclitaxel in patients with metastatic uveal melanoma: SWOG S0512. ( Aparicio, AM; Bhatia, S; Lao, CD; Margolin, KA; Moon, J; Othus, M; Ribas, A; Sondak, VK; Weber, JS, 2012)
"Migration of HUVEC cells, the ability of HUVEC cells to form tubes, and proliferative capacity of a human ocular melanoma cell line were tested in the presence of lenalidomide and sorafenib alone and in combination."	3.74	Combination therapy targeting the tumor microenvironment is effective in a model of human ocular melanoma. ( Blansfield, JA; Kachala, S; Libutti, SK; Lorang, D; Mangiameli, DP; Muller, GW; Schafer, PH; Stirling, DI, 2007)

Research

Studies (3)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

6-month Progression-free Survival

Timeframe	Studies, this research(%)	All Research%
pre-1990	1 (33.33)	18.7374
1990's	0 (0.00)	18.2507
2000's	1 (33.33)	29.6817
2010's	1 (33.33)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Bhatia, S	1
Moon, J	1
Margolin, KA	1
Weber, JS	1
Lao, CD	1
Othus, M	1
Aparicio, AM	1
Ribas, A	1
Sondak, VK	1
Mangiameli, DP	1
Blansfield, JA	1
Kachala, S	1
Lorang, D	1
Schafer, PH	1
Muller, GW	1
Stirling, DI	1
Libutti, SK	1
Bullen, MA	1
Godden, TJ	1
Hale, BT	1
Preece, AW	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) in Combination With Carboplatin and Paclitaxel in Patients With Metastatic Uveal Melanoma[NCT00329641]	Phase 2	25 participants (Actual)	Interventional	2011-02-28	Completed
Phase II Clinical Protocol for the Treatment of Patients With Previously Untreated CLL With Four or Six Cycles of Fludarabine and Cyclophosphamide With Rituximab (FCR) Plus Lenalidomide Followed by Lenalidomide Consolidation/ Maintenance[NCT01723839]	Phase 2	21 participants (Actual)	Interventional	2012-02-22	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Measured from the date of registration to the first of progression or death due to any cause with patients last known to be alive and progression-free censored at the date of last contact (NCT00329641)
Timeframe: Every 6 weeks for the first 8 cycles of therapy, and then every 9 weeks until disease progression for up to 3 years after registration or until death

One-year Overall Survival

Intervention	Percent of population (Number)
Sorafenib, Carboplatin, Paclitaxel	29

Measured from date of registration to study until death due to any caused with observations last known to be alive censored at the date of last contact (NCT00329641)
Timeframe: Every 6-9 weeks until progression, after progression every six months for first two years and annually thereafter up to 3 for up to 3 years after registration or until death

Response Rate (Complete and Partial Response)

Intervention	Percentage of population (Number)
Sorafenib, Carboplatin, Paclitaxel	42

Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease. (NCT00329641)
Timeframe: Every 6 weeks for the first 8 cycles of therapy, then every three cycles (9 weeks) until progression

Toxicity

Intervention	participants (Number)
Sorafenib, Carboplatin, Paclitaxel	0

Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event (NCT00329641)
Timeframe: Weekly during the first cycle of therapy, then prior to each cycle (one cycle = 3 weeks)

Complete Response

Intervention	Participants with a given type of AE (Number)
	Calcium, serum-low (hypocalcemia)	Cataract	Diarrhea	Fatigue (asthenia, lethargy, malaise)	Febrile neutropenia	Hemoglobin	Infec w/ Gr 3/4 neut-Urinary tract	Leukocytes (total WBC)	Lymphopenia	Mucositis/stomatitis (func/symp) - Pharynx	Neuropathy: sensory	Neutrophils/granulocytes (ANC/AGC)	Platelets	Pruritus/itching	Rash/desquamation	Vision-blurred vision
Intervention	1	1	2	1	1	2	1	4	2	1	2	10	4	1	5	1

Analysis of the Primary Endpoint: The complete responses will be estimated by the number of patients with CR divided by the total number of evaluable patients. (NCT01723839)
Timeframe: 28 day cycle, up to 4 cycles

Overall Response Rate

Intervention	Percentage of Participants (Number)
FCR With Lenalidomide	45

Analysis of the other Secondary Endpoints: The overall response rate will be estimated by the number of patients with complete and partial responses divided by the total number of evaluable patients. (NCT01723839)
Timeframe: 28 day cycle, up to 6 cycles

niacinamide and Cancer of Eye