Phase 1 Trial on Anvirzel - no objective anti-tumor responses?

May 15, 2009

Hello folks.

Do we know why the clinical trial on Anvirzel at the Cleveland Cancer Clinic showed no "objective anti-tumor responses"?

Thank you.

peace and healing,

Glen from Illinois, USA

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http://www.ncbi.nlm.nih.gov/pubmed/16763787

Phase 1 trial of Anvirzel in patients with refractory solid tumors.

Invest New Drugs. 2006 Sep;24(5):423-7.

Mekhail T, Kaur H, Ganapathi R, Budd GT, Elson P, Bukowski RM.

Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, 9500 Euclid Ave., Cleveland, OH 44195, USA. mekhait

Anvirzel is an aqueous extract of the plant Nerium oleander which has been utilized to treat patients with advanced malignancies. The current study reports a phase 1 trial to determine the maximum tolerated dose (MTD) and safety of Anvirzel in patients with advanced, refractory solid tumors. Patients were randomized to receive this agent by intramuscular injection at doses of 0.1, 0.2, 0.4 ml/m2/day with subsequent patients receiving 0.8 or 1.2 ml/m2/day sequentially. Eighteen patients were enrolled and completed at least one treatment cycle of three weeks. Most patients developed mild injection site pain (78%). Other toxicities included fatigue, nausea, and dyspnea. Traditional dose limiting toxicity was not seen, but the MTD was defined by injection volume as 0.8 ml/m2/day. No objective anti-tumor responses were seen. Anvirzel can be safely administered at doses up to 1.2 ml/m2/day, with the amount administered intramuscularly limited by volume. The recommended phase II dose level is 0.8 ml/m2/day.

PMID: 16763787 [PubMed - indexed for MEDLINE]

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May 16, 2009

Phase I trials are simply to determine dose safety for susequent trials. Three weeks is way too short to expect tumor effects with Anvirzel.

Mike--- On Sat, 5/16/09, zanaglen <zanaglen wrote:

zanaglen <zanaglen Phase 1 Trial on Anvirzel - no objective anti-tumor responses?oleander soup Date: Saturday, May 16, 2009, 12:41 AM

Hello folks.

Do we know why the clinical trial on Anvirzel at the Cleveland Cancer Clinic showed no "objective anti-tumor responses"?

Thank you.

peace and healing,

Glen from Illinois, USA

------------ --------- --------- --------- --------- --------- --------- --------- --------- --------- --------- --

http://www.ncbi. nlm.nih.gov/ pubmed/16763787

Phase 1 trial of Anvirzel in patients with refractory solid tumors.

Invest New Drugs. 2006 Sep;24(5):423- 7.

Mekhail T, Kaur H, Ganapathi R, Budd GT, Elson P, Bukowski RM.

Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, 9500 Euclid Ave., Cleveland, OH 44195, USA. mekhait (AT) ccf (DOT) org

Anvirzel is an aqueous extract of the plant Nerium oleander which has been utilized to treat patients with advanced malignancies. The current study reports a phase 1 trial to determine the maximum tolerated dose (MTD) and safety of Anvirzel in patients with advanced, refractory solid tumors. Patients were randomized to receive this agent by intramuscular injection at doses of 0.1, 0.2, 0.4 ml/m2/day with subsequent patients receiving 0.8 or 1.2 ml/m2/day sequentially. Eighteen patients were enrolled and completed at least one treatment cycle of three weeks. Most patients developed mild injection site pain (78%). Other toxicities included fatigue, nausea, and dyspnea. Traditional dose limiting toxicity was not seen, but the MTD was defined by injection volume as 0.8 ml/m2/day. No objective anti-tumor responses were seen. Anvirzel can be safely administered at doses up to 1.2 ml/m2/day, with the amount administered intramuscularly limited by volume.

The recommended phase II dose level is 0.8 ml/m2/day.

PMID: 16763787 [PubMed - indexed for MEDLINE]

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