Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Micronutrients

All Drugs and Chemicals

Vasodilator Agents

Lipid Regulating Agents

Hematinics

Vitamins

Niacinamide

Niacin

Nicotinic Acids

Folic Acid

Vitamin B Complex

Trace Elements

Hypolipidemic Agents

Antimetabolites

Nicotinamide

Nicotinic Acid

Vitamin B3

Folate

Vitamin B9

niacinamide

carbogen

radiation therapy

Peter J. Hoskin, MD

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carbogen and niacinamide may make tumor cells more sensitive to radiation therapy. It is not yet known whether radiation therapy is more effective with or without carbogen and niacinamide in treating patients who have bladder cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without carbogen and niacinamide in treating patients who have locally advanced bladder cancer.

OBJECTIVES:

* Compare the 6-month cystoscopic response in patients with locally advanced transitional cell carcinoma of the bladder treated with radical radiotherapy with or without radiosensitization with carbogen and niacinamide.
* Compare the local failure-free and overall disease-specific survival of patients treated with these regimens.
* Compare the treatment-related morbidity, in particular acute and chronic bowel and bladder symptoms, in patients treated with these regimens.
* Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive radical radiotherapy once daily, 5 days a week, for 4-6.4 weeks. Patients also receive oral niacinamide once daily 1.5-2 hours before initiation of each radiotherapy dose and carbogen through a closed breathing system (face mask with a tight air seal or a mouthpiece with nasal clip) once daily beginning 5 minutes before initiation and continuing until completion of each radiotherapy dose.
* Arm II: Patients receive radiotherapy as in arm I. Quality of life is assessed at baseline; at 4 weeks; at 3, 6, and 12 months; and then annually for 4 years.

Patients are followed at 8 and 12 weeks; at 6, 9, and 12 months; and then every 6 months for 4 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 330 patients (165 per treatment arm) will be accrued for this study.

Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer

A Multicenter Randomized Trial of Radical Radiotherapy With Carbogen in the Radical Treatment of Locally Advanced Bladder Cancer

Mount Vernon Cancer Centre at Mount Vernon Hospital

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Hodgkin Disease

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

Etoposide

Tin Fluorides

Etoposide phosphate

Vorinostat

Enzyme Inhibitors

Histone Deacetylase Inhibitors

Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg

Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg

Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg

Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2

Dose escalation scheme (400 mg)

Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.

Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg)

Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.

Dose escalation scheme (0, 25, 50, 100 mg/m2)

Etoposide is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid" and "topoisomerase II inhibitor."

Owen A O'Connor, MD, Ph.D.

The purpose of this study is to test the safety of a combination of two anticancer medicines, called vorinostat and etoposide, with a high dose of a vitamin called niacinamide. These medications will be tested at different dose levels. The investigators want to find out what effects, good and/or bad, it has on patients and their recurrent lymphoma. The first two drugs, vorinostat and niacinamide, suppress survival signals that lymphoma cells depend on. The third drug, etoposide can kill sensitive lymphoma cells alone or in combination with other chemotherapy drugs. Vorinostat is an anticancer agent that been approved by the Food and Drug Administration for use in cutaneous T-cell lymphoma. It is being evaluated in this study in combination with other anticancer medicines for use in other types of lymphoma. Vorinostat's use in combination with anticancer regimens is experimental. Niacinamide is a vitamin that is investigational or experimental when given at high doses as an anticancer agent. Niacinamide has not yet been approved by the Food and Drug Administration for use in lymphoma. Etoposide has been approved by the Food and Drug Administration for use in aggressive non-Hodgkin's lymphoma. However, the way it will be given in this clinical study is experimental.

Subjects will be treated with vorinostat administered orally with daily dosing for 14 days of a 21-day treatment cycle in combination with niacinamide administered orally for 14 days in 21-day treatment cycle and etoposide administered intravenously on days 8,9 and 10 of a 21-day treatment cycle. Etoposide dose will be escalated until maximum tolerated dose (MTD) is determined.

Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies

Phase I Study of Vorinostat in Combination With Niacinamide, and Etoposide for the Treatment of Patients With Relapsed and Refractory Lymphoid Malignancies

The highest number of cycles received by an individual participant in the treatment groups. Each cycle was 21 days long.

Merck Sharp & Dohme LLC

Columbia University

Adverse events were collected by patient reporting and physical exam with an attending and graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).

Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

Vorinostat (SAHA) and Niacinamide: Level 1

Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

Vorinostat (SAHA) and Niacinamide: Level 2

Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

Vorinostat (SAHA) and Niacinamide: Level 3

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

Vorinostat (SAHA) and Niacinamide: Level 4

Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

Vorinostat (SAHA) and Niacinamide: Level 5

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2

Vorinostat, Niacinamide and Etoposide: dose escalation scheme

Vorinostat, Niacinamide and Etoposide: Level 1

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2

Vorinostat, Niacinamide and Etoposide: dose escalation scheme

Vorinostat, Niacinamide and Etoposide: Level 2

V/N: Level 1

V/N: Level 2

V/N: Level 3

V/N: Level 4

V/N: Level 5

V/N/E: Level 1

V/N/E: Level 2

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2

Vorinostat, Niacinamide and Etoposide: dose escalation scheme

V/N/E: Level 3

Total

Age, Categorical

Sex: Female, Male

There were no subjects enrolled or evaluable in VNE Level 3 Arm.

Owen A. O'Connor, MD, Ph.D.

The Greatest Number of Cycles Received in Each Treatment Group

The Number of Dose Delays and Reductions at the MTD

The Prevalence of Anti-tumor Activity

Pharmacodynamic Markers of Target Effect in Paired Tissue Biopsies

Vorinostat: 400mg Niacinamide: 20-100 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

Vorinostat (SAHA) and Niacinamide: Level 1-5

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25-50 mg/m2

Vorinostat, Niacinamide and Etoposide: dose escalation scheme

Vorinostat, Niacinamide and Etoposide: Level 1-2

There were no evaluable patients at these levels.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer	NCT00033436	Bladder Cancer	niacinamide carbogen radiation thera...	18 Years -	National Cancer Institute (NCI)
Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies	NCT00691210	Hodgkin's Disea... Non-Hodgkin's L...	Vorinostat Niacinamide Etoposide	18 Years -	Columbia University
Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies	NCT00691210	Hodgkin's Disea... Non-Hodgkin's L...	Vorinostat Niacinamide Etoposide	18 Years -	Columbia University
Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer	NCT00033436	Bladder Cancer	niacinamide carbogen radiation thera...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for niacinamide

Every month we try and update this database with for niacinamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for niacinamide

Every month we try and update this database with for niacinamide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for niacinamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.