Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Nutritional and Metabolic Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Vitamin D Deficiency

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Vitamin D

Cholecalciferol

Lenalidomide

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

In this arm, patients will receive the standard lenalidomide dose along with an intensified level of Vitamin D maintenance regimen.

In this arm, patients will receive the standard lenalidomide dose along with a therapeutic level of Vitamin D regimen.

For first three cycles, taken orally once daily for 28 days at 10mg/day dose. After cycle 4, taken orally once daily at 15 mg/day dose

After replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are \> 30, will start maintenance therapy with Monthly replacement with 50,000 IU

Vitamin D - Intensified

After replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are \> 30, stop replacement and continue monitoring levels

Vitamin D - Therapeutic

Kelly Jenkins, MSN, RN

GCC Clinical Trials Office

Amany Keruakous, MD

The goal of this clinical trial is to evaluate post-transplant immune reconstitution and lymphocyte recovery as well as the 3-year progression-free survival of patients with multiple myeloma in two treatment arms. One arm will receive lenalidomide and an intensified regimen of maintenance VitD, and the other arm will receive lenalidomide and a therapeutic regimen of VitD. This clinical trial will also evaluate the overall response rate and survival for both treatment arms.

Management of multiple myeloma (MM) has changed significantly over the past 10 years. The use of three drug induction therapy followed by autologous stem cell transplantation (ASCT) has become standard of care for transplant eligible patients with MM since randomized trials showed improved progression-free survival (PFS) and overall survival (OS) with three drugs, albeit in the non-transplant setting.

Evidence suggests Vitamin D deficiency is correlated with poorer outcomes in this population; however, it is unknown if intensified Vitamin D supplementation improves outcomes. This clinical trial aims to address this question and will postulate the impact of Vitamin D on immunoregulatory functions and the hematopoietic niche microenvironment.

VitD3 Supplementation in Patients With Multiple Myeloma

EVALUATION OF CHOLECALCIFEROL (VitD3) MAINTENANCE SUPPLEMENTATION IN PATIENTS WITH MULTIPLE MYELOMA (MM) UNDERGOING TRANSPLANTATION AND IN COMBINATION WITH LENALIDOMIDE MAINTENANCE

Evaluate absolute lymphocyte count and the difference in subset analysis (absolute CD4 count, absolute CD8 count) 120 days after ASCT

Amany Keruakous, MD, MS.

Assistant Professor of Medicine

Digestive System Diseases

Stomach Neoplasms

Malnutrition

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Nutrition Disorders

Stomach Cancer

Enteral nutrition composed of carbohydrates and vitamins

carbohydrates

vitamins

Evaluation of the impact of preoperative nutritional support on clinical outcomes in patients at nutritional risk. The primary endpoint was the complication rate and the second endpoint was the length of stay.

Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002

Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002- A Prospective, Randomized Clinical Trial

The First Hospital of Jilin University

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Ascorbic Acid

Gemcitabine

Antioxidants

Antimetabolites

Protective Agents

Vitamin C

Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.

Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.

Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)

Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)

Gemcitabine with escalating ascorbic acid

Joseph J Cullen, MD

This is a phase II study. It is designed to provide information about if high-dose ascorbate (vitamin C) increases survival for pancreatic cancer patients. The hypothesis is that vitamin C is well tolerated and increases cancer treatment effectiveness, lengthening survival time for patients with advanced pancreatic cancer.

Adenocarcinoma of the pancreas is the fourth leading cause of cancer death in the United States and is increasing in incidence; the prognosis remains dismal. We propose to investigate an entirely new approach, using pharmacological ascorbate, combined with Gemcitabine, to treat this cancer. Intravenous ascorbate (i.e., ascorbic acid, vitamin C), but not oral ascorbate, produces high plasma concentrations, which are in the range that can be cytotoxic to tumor cells. Though ascorbate has been utilized in cancer therapy, few studies have investigated intravenous deliver of ascorbate. Preliminary studies from our group have demonstrated that ascorbate induces oxidative stress and cytotoxicity in pancreatic cancer cells; this cytotoxicity appears to be greater in tumor vs. normal cells. We hypothesize that production of H2O2 mediates the increased susceptibility of pancreatic cancer cells to ascorbate-induced metabolic oxidative stress. Gemcitabine is the standard chemotherapy drug used to treat pancreatic cancer.

Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer

Pharmacological Ascorbate for the Control of Metastatic and Node-Positive Pancreatic Cancer (PACMAN): A Phase II Trial

Time to event outcome measure (death), measured in days from cycle 1 day 1.

Time-to-event outcome measure (initial disease progression) measured in days from cycle 1 day 1 to day of first progression as defined by RECIST criteria from NCI.

Adverse events linked to ascorbate will be categorized and quantified using CTCAE v4 at the bottom of each cycle. Incidence and frequency will be compared to scientific literature

F2-isoprostane is a marker of systemic oxidative stress.

Ascorbate levels will be taken at the bottom of each cycle to assess therapeutic dose window.

Susan L Bader Foundation of Hope

Holden Comprehensive Cancer Center

National Cancer Institute (NCI)

Joseph J. Cullen

Professor of Surgery

Adverse event reporting is consistent with the definition provided by clinicaltrials.gov

Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.

Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.

Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)

Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)

Gemcitabine With Escalating IV Ascorbate

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

There was only one treated participant. Conclusions cannot be drawn from these data due to limited sampling size.

Joseph J. Cullen, MD, FACS

Overall Survival

Progression Free Survival

Due to n=1 and study termination, the data were not analyzed.

Number of Drug-related Adverse Events Per Cycle

F2-isoprostane Levels

Ascorbate Levels

Overall Study

Carcinoma

Adenocarcinoma

Sarcoma

Desmoplastic Small Round Cell Tumor

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Intravenous ascorbic acid, 1.5g/kg at an infusion rate not to exceed 250mg/min.

Intravenous administration of up to 1.5gm/kg of ascorbic acid, twice weekly for up to 12-weeks.

Ascorbic acid (vitamin C)

G D Murphy, MD

J Bolt, PhD

The study is designed to determine if high doses of intravenous ascorbic acid (vitamin C) can be effective in managing solid tumor diseases. Secondary goals are determination of any palliative effects and improvement of quality of life of patients.

Ascorbic acid has demonstrated selective cytotoxicity in cancer cells in vitro, while sparing normal cells from its peroxidative effects. This study will examine the effect, if any, of the drug when dosed in patients at a level sufficient to achieve transient serum states of 400mg/dl. Safety of the drug has been shown in a Phase I study when dosed as high as 1.5gm/kg. Patients will be treated twice weekly for 12 weeks (24-cycles) and evaluated for response using RECIST criteria. Patients showing stable disease or objective response will remain on study for up to one year or until absence of measurable disease or disease progression.

Study of High Dose Intravenous (IV) Ascorbic Acid in Measurable Solid Tumor Disease

Phase 2 Study of High Dose Ascorbic Acid in Solid Tumor Disease

Efficacy of treatment will be evaluated at 12-weeks. Efficacy is evaluated using RECIST criteria to determine disease response by CT scan interpretation

Quality of life during treatment will be measured using FACT questionnaires.

Situs Cancer Research Center

Colorectal Neoplasms

Colonic Diseases

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Irinotecan

Camptothecin

Enzyme Inhibitors

Topoisomerase I Inhibitors

Cola

Ascorbic Acid (50-100g, 3x weekly) with 350mg/m2 irinotecan once a week every 3 weeks

350mg/m2 irinotecan once a week every 3 weeks

Daniel A Monti, MD

This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with irinotecan versus treatment with irinotecan alone in patients with recurrent or advanced colorectal cancer who have failed at least one treatment regimen with a 5-FU based therapy. This study will be conducted as an amendment to Investigational New Drug # 77486.

Phase I: To assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated. This aim will be assessed by enrolling a minimum of 6 subjects meeting inclusion criteria, using a modified 3+3 design. Safety will be assessed with the following: toxicity graded by the NCI CTC, urinalysis pre- and post-infusion, basic metabolic panel, and CBC. From our experience and in the experience of our study collaborators, we hypothesize that the combination of IV AA with irinotecan will not be associated with adverse events.

Phase II: To utilize CT or PET/CT (when available) scans to evaluate disease progression to assess overall tumor response rate (complete and partial response) in subjects with advanced or recurrent colorectal cancer treated with the combination of ascorbic acid and irinotecan versus irinotecan alone.

Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA

Phase I/II Study of Intravenous Ascorbic Acid in Combination With Irinotecan Versus Irinotecan Alone for Advanced Colorectal Cancer

Safety: The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

To evaluate progression-free survival related to treatment of patients with advanced or recurrent colorectal cancer

Thomas Jefferson University

The study was closed early due to lack of accrual. Adverse event data were collected for the patients who were enrolled in the study.

Ascorbic Acid (50-100g, 3x weekly)

Ascorbic Acid: 3x a week for 9 weeks

Ascorbic Acid+Irinotecan

Standard of Care (Irinotecan Alone)

Total

The Phase 2 portion of this study never enrolled and therefore no patients were enrolled to the standard of care arm.

Dr. Daniel Monti

The study was closed early due to lack of accrual. The data were not collected or analyzed.

Number of Participants That Experience Serious Adverse Events as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Number of Participants That Are Alive After 11 Weeks.

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Transitional Cell Carcinoma

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Hematinics

Dexamethasone

Pemetrexed

Cisplatin

Dexamethasone acetate

Folic Acid

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Folic Acid Antagonists

Folinic Acid

Methylcobalamin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

Pemetrexed 500 mg/m2 IV over 10 minutes on D1 every 3 weeks

Cisplatin 70 mg/m2 IV over 60 minutes on D1 every 21 days

Dexamethasone 4 mg bid PO from D-1 to D2 every 3 weeks

Folic acid 350 ug - 600 ug daily from D-7 daily vitamin B12 1,000 ug every 9 weeks from D-7

Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single agent as first-line and second-line treatment for advanced urothelial carcinoma. The response rates were 32% and 28% for the first-line and second-line setting, respectively. Cisplatin is one the most active chemotherapeutic agents in urothelial cancer, frequently used as combination chemotherapy such as GP (gemcitabine plus cisplatin) or MVAC (methotrexate, vinblastine, adriamycin, and cisplatin).

Pemetrexed and cisplatin showed favorable activity profile in advanced non-small cell lung cancer with highly favorable toxicity profile.

This study is to assess the efficacy and safety of pemetrexed plus cisplatin in advanced urothelial carcinoma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
VitD3 Supplementation in Patients With Multiple Myeloma	NCT05846880	Multiple Myelom...	Lenalidomide Vitamin D - Int... Vitamin D - The...	18 Years -	Augusta University
Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002	NCT01830907	Malnutrition Gastric Cancer	carbohydrates vitamins	18 Years - 85 Years	The First Hospital of Jilin University
Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer	NCT01515046	Pancreatic Neop... Pancreatic Canc...	Gemcitabine wit...	18 Years -	University of Iowa
Study of High Dose Intravenous (IV) Ascorbic Acid in Measurable Solid Tumor Disease	NCT01125449	Sarcoma Adenocarcinoma Carcinoma Multiple Myelom... Desmoplastic Sm...	Ascorbic acid (...	18 Years -	Situs Cancer Research Center
Study of High Dose Intravenous (IV) Ascorbic Acid in Measurable Solid Tumor Disease	NCT01125449	Sarcoma Adenocarcinoma Carcinoma Multiple Myelom... Desmoplastic Sm...	Ascorbic acid (...	18 Years -	Situs Cancer Research Center
Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA	NCT01550510	Stage IV Colore...	Ascorbic Acid Irinotecan	18 Years -	Thomas Jefferson University
Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma	NCT01490437	Urothelial Carc...	Pemetrexed Cisplatin Dexamethasone Vitamins	18 Years - 70 Years	Asan Medical Center
VitD3 Supplementation in Patients With Multiple Myeloma	NCT05846880	Multiple Myelom...	Lenalidomide Vitamin D - Int... Vitamin D - The...	18 Years -	Augusta University
Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA	NCT01550510	Stage IV Colore...	Ascorbic Acid Irinotecan	18 Years -	Thomas Jefferson University

Spots Global Cancer Trial Database for vitamins

Every month we try and update this database with for vitamins 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 vitamins

Every month we try and update this database with for vitamins 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 vitamins 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.