Clinical Trials

The following research studies are being conducted in Integrative Medicine. If you are interested in participating, call 913-588-6104 to leave your contact information and the clinical research coordinator will contact you.

Jefferson Foundation: Pharmacokinetic Evaluation of Intravenous Vitamin C

This research study will be conducted at the University of Kansas Medical Center with Jeanne Drisko, M.D., as the principal investigator.  The goal of testing intravenous vitamin C is to achieve a desired good outcome at the smallest dose with minimal side effects.

It is known that people with cancer are using high doses of intravenous vitamin C as a cancer treatment and this is occurring not infrequently. When vitamin C is given in this manner, it is known that it acts like a drug and not a vitamin. It is not known how high doses of intravenous vitamin C are handled and eliminated by the body or if it is safe. This is in spite of the fact that high-dose intravenous vitamin C has been given to patients for over 30 years. No formal pharmacokinetic study has been done at these high doses.

Pharmacokinetic evaluation is a type of drug study that examines the processes of absorption, distribution, and elimination of a drug by the body determines.  It determines how rapidly and for how long the drug will appear at the target location. Also, the relationship between a beneficial or toxic effect of a drug and the safety of the drug needs to be established for different concentrations.

Approximately 12 participants with cancer and approximately 21 healthy people will be enrolled and seen in the Program in Integrative Medicine Infusion Clinic.

If you are interested in participating in this study, or would like more information, please contact our clinical research coordinator at 913-588-6104.


 

Pancreatic Cancer Trial

Translation of in vitro and in vivo Ascorbate Research Into a New Treatment Option for Pancreatic Cancer: Phase I/IIa Clinical Trial Funded by the Hecht Foundation

(1) Safety and Effectiveness of Adding Intravenous Vitamin C to Gemcitabine Chemotherapy for Pancreatic Cancer, and (2) Assessing Pharmacokinetic and Pharmacodynamic Interactions When Adding Intravenous Ascorbate to Frontline Gemcitabine Chemotherapy in the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

This study is in advanced pancreatic cancer patients not eligible for surgical resection undergoing chemotherapy. The Primary Hypothesis is that adding IV vitamin C to gemcitabine chemotherapy for pancreatic cancer will be safe and not inhibit the effectiveness of gemcitabine chemotherapy. We will determine if it is safe to combine gemcitabine chemotherapy with IV vitamin C. Initially 7 participants will be enrolled and if no significant interaction defined, an additional 7 will be enrolled. We will enroll up to 14 participants with pancreatic cancer. Safety will be assessed by obtaining the following evaluations: toxicity graded by the NCI CTC v 4.0, urinalysis pre- and post-infusion, ECG, basic metabolic panel, bicarbonate (pH surrogate marker), CBC, and osmolality. This protocol will be conducted in the Clinical Translational Science Unit, the Integrative Medicine Infusion Clinic, and The University of Kansas Cancer Center at the University of Kansas Medical Center.

If deemed safe and no significant change identified in gemcitabine chemotherapy levels, the participants enrolled will be continued on the dual treatment plan of gemcitabine chemotherapy and IV ascorbate given on a prescribed schedule. The participants will be followed until there is progression of disease with a secondary hypothesis that there may be a benefit when combining the front-line chemotherapy with IV ascorbate. If there appears to be a benefit, a Phase II clinical trial is planned.

If you are interested in participating in this study or would like more information, please contact our clinical research coordinator at 913-588-6104.

Last modified: Jul 03, 2013
Our Coordinator

Jean Sunega
Clinical Research Coordinator

IV Vitamin C Clinical Trial

VitC

Participants needed for a clinical trial investigating the effect of IV Vitamin C (Ascorbic Acid). This type of study examines processes of absorption, distribution, and elimination of IV Vitamin C by the body. We are currently recruiting participants previously diagnosed with cancer and have completed treatment.

For study information

Contact information: Jean Sunega: jsunega@kumc.edu or 913-588-6104. 

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