Related Experiment Video

Updated: Aug 7, 2026

Transarterial Administration of Oncolytic Viruses for Locoregional Therapy of Orthotopic HCC in Rats
08:55

Transarterial Administration of Oncolytic Viruses for Locoregional Therapy of Orthotopic HCC in Rats

Published on: April 15, 2016

Phase 1 trial of Anvirzel in patients with refractory solid tumors

Tarek Mekhail1, Hanspreet Kaur, Ram Ganapathi

  • 1Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, 9500 Euclid Ave., Cleveland, OH 44195, USA. mekhait@ccf.org

Investigational New Drugs
|June 10, 2006
PubMed

Insights

Anvirzel, derived from Nerium oleander, was tested in a Phase 1 trial for advanced cancers. The maximum tolerated dose (MTD) was 0.8 ml/m2/day, with safety established up to 1.2 ml/m2/day.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Anvirzel is an aqueous extract from Nerium oleander.
  • It has been used in treating advanced malignancies.

Purpose of the Study:

  • To determine the maximum tolerated dose (MTD) of Anvirzel.
  • To assess the safety of Anvirzel in patients with advanced, refractory solid tumors.

Main Methods:

  • Phase 1 clinical trial.
  • Intramuscular injection of Anvirzel at escalating doses (0.1 to 1.2 ml/m2/day).
  • 18 patients with advanced, refractory solid tumors were enrolled.

Main Results:

  • The maximum tolerated dose (MTD) was determined to be 0.8 ml/m2/day, limited by injection volume.
  • Most common toxicity was mild injection site pain (78%).
  • No objective anti-tumor responses were observed.

Conclusions:

  • Anvirzel can be safely administered intramuscularly up to 1.2 ml/m2/day.
  • The recommended dose for Phase 2 trials is 0.8 ml/m2/day.
  • Further investigation is warranted despite lack of observed anti-tumor activity.

Related Concept Videos

Treatment Resistent Cancers02:56

Treatment Resistent Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
Treatment Resistant Cancers02:56

Treatment Resistant Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
Antiviral Nucleoside Inhibitors01:22

Antiviral Nucleoside Inhibitors

Antiviral Nucleoside InhibitorsAntiviral nucleoside inhibitors are structural analogs of natural nucleosides that interfere with viral DNA or RNA synthesis. These compounds selectively target viral polymerases due to their resemblance to host nucleosides, thereby disrupting viral genome replication.Mechanism of Acyclovir ActionAcyclovir is a guanosine analog with a three-carbon acyclic side chain. It selectively targets herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2),...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...