Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

Anti-Inflammatory Agents

Vitamins

Gemcitabine

Ondansetron

Granisetron

Dexamethasone

Ascorbic Acid

Dexamethasone acetate

Dolasetron

Trace Elements

Antimetabolites

Antioxidants

Protective Agents

Vitamin C

Week 1: 2 visits for escalating doses of intravenous ascorbic acid (IV C). First dose 25 gm followed by 50 gm 2nd visit. Week 2: 3 visits escalating doses of IV C, 75 grams, 100 grams, and 125 grams. Week 3: 2 visits pharmacokinetic evaluation of intravenous ascorbic acid alone at 125 grams; return to the infusion clinic the following morning for a 24 hour blood draw; 2nd visit receive the first infusion of gemcitabine chemotherapy for PK evaluation of gemcitabine alone. Week-4: gemcitabine and IV C co-administered for pharmacokinetics of both drugs to assess for PK variability related to drug-drug interactions. Subjects will return to the infusion clinic the following morning for 24 hour blood draw.

The first 5 study visits will all take place in the General Clinical Research Center (GCRC). During these visits you will receive IV doses of Vitamin C. The dose of Vitamin C will be started at 25 grams and may be increased up to 125 grams over a two week period. There may be changes in the amount of Vitamin C that you receive based on your blood test levels. The study staff will go over this in more detail with you. The amount of fluid you receive depends on the dose and can be from 2 1/3 cups to 5 cups.

Intravenous Vitamin C

Participants receive dexamethasone 10 mg as pretreatment antiemetic; may be given ondansetron, granisetron, or dolasetron, per oncologist. Gemcitibane 1,000mg/m2 IV over 30 minutes Q 21 days. Cycle of treatment: infusions once weekly for 2 consecutive weeks followed by 1 week of rest to continue treatment schedule until they experience disease progression or unacceptable toxicity. CR, PR or SD: treatment will be continued for at least 6 cycles. Discontinuation of therapy may be considered if agreed upon by the participant and oncologist. Dose Modifications: If the patient experiences more than one toxicity, each requiring a dose reduction, follow the guidelines that give the largest dose reduction for the drug. Subsequent doses can be adjusted to as low as 500 mg/m2 for gemcitabine.

Jeanne Drisko, MD

In the United States, approximately 30,000 new cases of pancreatic cancer are diagnosed each year and an almost equal number of deaths are related to this cancer. Different types of chemotherapeutic treatments are used that target different parts of the cancer cell with some success, but there is room for other treatment options.

It is known that people with cancer are using high doses of intravenous vitamin C also known as ascorbate, as a cancer treatment and this is occurring frequently. When Vitamin C is given in this manner, it is not taken by mouth; instead, it enters your body through an IV (intravenous) site, or tube that is inserted through a needle into your vein. If you have a port-a-cath in place, the IV will be given using your port. When Vitamin C enters your body through an IV site, it is known that it acts like a drug and not a vitamin. It produces a substance around the cancer cells called hydrogen peroxide. It has been seen in animal research studies that hydrogen peroxide kills the cancer cells while leaving the normal cells unharmed.

Currently the FDA does not approve the use of high-dose intravenous Vitamin C as a cancer treatment. The use of intravenous Vitamin C in this study is experimental. Furthermore, it is important to know that we do not expect the intravenous Vitamin C given in this study to be healing for the treatment of your cancer.

The purpose of this study is to determine if it is safe to give Vitamin C by the vein at high doses to people with pancreatic cancer and if Vitamin C interferes with how well the chemotherapy works on cancer cells. This study will also look at how the body processes of Vitamin C. This study will also help researchers to learn more about long Vitamin C stays in the blood stream, and how rapidly it is used by the body.

New Treatment Option for Pancreatic Cancer

Translation of in Vitro and in Vivo Ascorbate Research Into a New Treatment Option for Pancreatic Cancer: Phase I/IIa Clinical Trial

This will be accomplished by enrolling up to 14 participants fitting inclusion criteria into the Phase I portion of the trial: 7 participants will be enrolled at the determined dose levels and if no significant adverse event is identified, then 7 additional participants will be enrolled. Safety will be assessed by obtaining the following evaluations: toxicity graded by the NCI CTCAE v 4.0, urinalysis pre- and post-infusion, ECG, basic metabolic panel, bicarbonate (pH surrogate marker), CBC, and osmolality.

By measuring PK data when combining gemcitabine chemotherapy along with IV ascorbate on the same day, it will be determined if there are reduced gemcitabine levels in the presence of ascorbate. Initially 7 participants will be enrolled and if no significant interaction defined, an additional 7 will be enrolled.

Lotte & John Hecht Memorial Foundation

University of Kansas Medical Center

Jeanne Drisko, MD, CNS, FACN

Director Integrative Medicine

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)

Gemcitabine and Erlotinib

50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.

Daniel Monti, MD, MBA

Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study.

Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer

Sidney Kimmel Cancer Center at Thomas Jefferson University

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.

Intravenous vitamin C

Daniel Monti, MD

Eligible candidates will be adults with aggressive or very aggressive NHL (WHO classification diagnosis confirmed by histological tumor examination). Patients must have failed one or more prior NHL chemotherapy or antibody therapy with curative intent, and the disease must not have progressed within 60 days of last therapy. In addition, patients must not be candidates for potentially curative therapy, such as HSCT, or they must have refused these alternative therapies. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. Intravenous ascorbic acid will be given in a dose based on the plasma vitamin C level to reach a level in the range of 300 to 350 mg/dL. Vitamin C infusions will be given three times a week on a schedule that allows at least 24 hours between each infusion, for a total of ten weeks (30 infusions). If disease progression occurs before or at the ten week assessment, then we discontinue protocol, based on futility. Toxicity and adverse events also will result in immediate discontinuation (details available in full protocol). If there is lack of disease progression or disease improvement, proceed and reassess again at 10 week intervals, for a total of three 10 week intervals. Initial criteria are based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson et al., Report of an international workshop to standardize response criteria for non-Hodgkin's lymphoma, Journal of Clinical Oncology, 1999, Vol. 17, No4, 1244-1253); response for this study will utilize PET in accordance with revised criteria (Cheson et al. Revised response criteria for malignant lymphoma. J of Clin Oncol 2007; 25(5): 579-586). We select 20 patients as an appropriate study size to evaluate a true response rate to therapy, compared to just the observed response.

Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)

Phase II Trial of High Dose Intravenous Vitamin C in Patients With Refractory Non-Hodgkin Lymphoma

Intravenous vitamin C

Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.

Age, Continuous

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Study was terminated due to poor accrual. No reportable data has been collected for any of the specified outcome measures.

Progression-free Survival

Duration of Response

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
New Treatment Option for Pancreatic Cancer	NCT01364805	Pancreatic Canc...	Intravenous Vit... Gemcitabine	21 Years -	University of Kansas Medical Center
Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer	NCT00954525	Metastatic Panc...	Gemcitabine and... Intravenous Vit...	18 Years - 75 Years	Thomas Jefferson University
Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)	NCT00626444	Non-Hodgkin Lym...	Intravenous vit...	18 Years -	Thomas Jefferson University
Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)	NCT00626444	Non-Hodgkin Lym...	Intravenous vit...	18 Years -	Thomas Jefferson University

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