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A phase Ib clinical trial of PV701, a milk-derived protein extract, for the prevention and treatment of oral mucositis in patients undergoing high-dose BEAM chemotherapy.
Biol Blood Marrow Transplant. 2005 Jul; 11(7):512-20.BB

Abstract

Despite the best available agents to prevent mucositis, most patients receiving high-dose chemoradiotherapy regimens experience severe mucositis, and new therapies are needed. In this study, we evaluated the safety and tolerability of a milk-derived growth factor extract (PV701 mouthwash) intended to prevent oral mucositis (OM) after carmustine, etoposide, cytosine arabinoside, and melphalan (BEAM) chemotherapy. PV701 mouthwash (15 mL x 13.5 mg/mL) was administered 6 times a day for 12 days, from day--6 to day +5, to patients with lymphoma, who were given BEAM on day--6 to day--2, with autologous stem cells infused on day 0. Dose de-escalation of PV701 was planned if dose-limiting toxicities occurred. The severity and duration of OM, the duration of enteral/parenteral feeding, the requirement for intravenous opiates, and admission to intensive care were recorded. Outcomes were also compared with those of historical control patients. Nine patients received PV701 13.5 mg/mL. PV701 was well tolerated, and no dose-limiting toxicities were observed. Compared with 89 historical controls, the 9 PV701-treated patients had significantly less frequent grade 2 or 3 OM (P=.0006) and had grade>or=3 OM for an estimated 5 fewer days (P=.0003). There was a reduction in the need for enteral/parenteral feeding (P=.012), its duration (P=.010), and its frequency (P=.022) and in the duration of intravenous opiates (P=.0006). We conclude that PV701 mouthwash is readily administered with minimal side effects at a dose of 1215 mg/d, and further investigation of this agent is warranted.

Authors+Show Affiliations

Hematology Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. Miles.Prince@petermac.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15983551

Citation

Prince, H Miles, et al. "A Phase Ib Clinical Trial of PV701, a Milk-derived Protein Extract, for the Prevention and Treatment of Oral Mucositis in Patients Undergoing High-dose BEAM Chemotherapy." Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation, vol. 11, no. 7, 2005, pp. 512-20.
Prince HM, Regester G, Gates P, et al. A phase Ib clinical trial of PV701, a milk-derived protein extract, for the prevention and treatment of oral mucositis in patients undergoing high-dose BEAM chemotherapy. Biol Blood Marrow Transplant. 2005;11(7):512-20.
Prince, H. M., Regester, G., Gates, P., Jablonskis, L., Seymour, J. F., Lillie, K., West, R., Wolf, M., Januszewicz, H., & Belford, D. (2005). A phase Ib clinical trial of PV701, a milk-derived protein extract, for the prevention and treatment of oral mucositis in patients undergoing high-dose BEAM chemotherapy. Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation, 11(7), 512-20.
Prince HM, et al. A Phase Ib Clinical Trial of PV701, a Milk-derived Protein Extract, for the Prevention and Treatment of Oral Mucositis in Patients Undergoing High-dose BEAM Chemotherapy. Biol Blood Marrow Transplant. 2005;11(7):512-20. PubMed PMID: 15983551.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A phase Ib clinical trial of PV701, a milk-derived protein extract, for the prevention and treatment of oral mucositis in patients undergoing high-dose BEAM chemotherapy. AU - Prince,H Miles, AU - Regester,Geoff, AU - Gates,Priscilla, AU - Jablonskis,Lina, AU - Seymour,John F, AU - Lillie,Kate, AU - West,Raelene, AU - Wolf,Max, AU - Januszewicz,Henry, AU - Belford,David, PY - 2005/6/29/pubmed PY - 2005/12/13/medline PY - 2005/6/29/entrez SP - 512 EP - 20 JF - Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation JO - Biol Blood Marrow Transplant VL - 11 IS - 7 N2 - Despite the best available agents to prevent mucositis, most patients receiving high-dose chemoradiotherapy regimens experience severe mucositis, and new therapies are needed. In this study, we evaluated the safety and tolerability of a milk-derived growth factor extract (PV701 mouthwash) intended to prevent oral mucositis (OM) after carmustine, etoposide, cytosine arabinoside, and melphalan (BEAM) chemotherapy. PV701 mouthwash (15 mL x 13.5 mg/mL) was administered 6 times a day for 12 days, from day--6 to day +5, to patients with lymphoma, who were given BEAM on day--6 to day--2, with autologous stem cells infused on day 0. Dose de-escalation of PV701 was planned if dose-limiting toxicities occurred. The severity and duration of OM, the duration of enteral/parenteral feeding, the requirement for intravenous opiates, and admission to intensive care were recorded. Outcomes were also compared with those of historical control patients. Nine patients received PV701 13.5 mg/mL. PV701 was well tolerated, and no dose-limiting toxicities were observed. Compared with 89 historical controls, the 9 PV701-treated patients had significantly less frequent grade 2 or 3 OM (P=.0006) and had grade>or=3 OM for an estimated 5 fewer days (P=.0003). There was a reduction in the need for enteral/parenteral feeding (P=.012), its duration (P=.010), and its frequency (P=.022) and in the duration of intravenous opiates (P=.0006). We conclude that PV701 mouthwash is readily administered with minimal side effects at a dose of 1215 mg/d, and further investigation of this agent is warranted. SN - 1083-8791 UR - https://www.unboundmedicine.com/medline/citation/15983551/A_phase_Ib_clinical_trial_of_PV701_a_milk_derived_protein_extract_for_the_prevention_and_treatment_of_oral_mucositis_in_patients_undergoing_high_dose_BEAM_chemotherapy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1083879105002326 DB - PRIME DP - Unbound Medicine ER -