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Evidence-Based Complementary and Alternative Medicine
Volume 2013 (2013), Article ID 964592, 11 pages
http://dx.doi.org/10.1155/2013/964592
Research Article

NCCAM/NCI Phase 1 Study of Mistletoe Extract and Gemcitabine in Patients with Advanced Solid Tumors

1The Cancer Team at Bellin Health, 1580 Commanche Avenue, Green Bay, WI 54313, USA
2National Center for Complementary and Alternative Medicine, NIH, Bethesda, MD, USA
3Samuelli Institute, Alexandria, VA, USA
4Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA
5University of Miami, Miami, FL, USA
6Research Service (151), Veterans Affairs Medical Center, and Department of Medicine, Georgetown University School of Medicine, Washington, DC, USA
7University of Nebraska Medical Center, Omaha, NE, USA
8Washington Cancer Institute, Washington Hospital Center, Washington, DC, USA
9Department of Medicine, Hematology and Medical Oncology Division, Uniformed Services University of the Health Sciences, Bethesda, MD, USA

Received 14 April 2013; Revised 23 July 2013; Accepted 17 September 2013

Academic Editor: Gunver Kienle

Copyright © 2013 Patrick J. Mansky et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose. European Mistletoe (Viscum album L.) extracts (mistletoe) are commonly used for cancer treatment in Europe. This phase I study of gemcitabine (GEM) and mistletoe in advanced solid cancers (ASC) evaluated: (1) safety, toxicity, and maximum tolerated dose (MTD), (2) absolute neutrophil count (ANC) recovery, (3) formation of mistletoe lectin antibodies (ML ab), (4) cytokine plasma concentrations, (5) clinical response, and (6) pharmacokinetics of GEM. Methods. Design: increasing mistletoe and fixed GEM dose in stage I and increasing doses of GEM with a fixed dose of mistletoe in stage II. Dose limiting toxicities (DLT) were grade (G) 3 nonhematologic and G4 hematologic events; MTD was reached with 2 DLTs in one dosage level. Response in stage IV ASC was assessed with descriptive statistics. Statistical analyses examined clinical response/survival and ANC recovery. Results. DLTs were G4 neutropenia, G4 thrombocytopenia, G4 acute renal failure, and G3 cellulitis, attributed to mistletoe. GEM 1380 mg/m2 and mistletoe 250 mg combined were the MTD. Of 44 patients, 24 developed nonneutropenic fever and flu-like syndrome. GEM pharmacokinetics were unaffected by mistletoe. All patients developed ML3 IgG antibodies. ANC showed a trend to increase between baseline and cycle 2 in stage I dose escalation. 6% of patients showed partial response, 42% stable disease. Median survival was 200 days. Compliance with mistletoe injections was high. Conclusion. GEM plus mistletoe is well tolerated. No botanical/drug interactions were observed. Clinical response is similar to GEM alone.