Abstract | GOALS OF WORK: MATERIALS AND METHODS: This study was a single-center, open-label, single-dose escalation, phase I trial in patients undergoing high-dose chemotherapy (HDCT) and autologous peripheral blood stem cell transplant (PBSCT). Velafermin was administered 24 h after stem cell infusion as a single intravenous dose infused over 15 min. Clinical safety variables were assessed and OM status scored daily for 30 days using the World Health Organization (WHO) grading scale. MAIN RESULTS: Thirty patients were treated with velafermin at doses of 0.03 (n = 10), 0.1 (n = 10), 0.2 (n = 8), or 0.33 mg/kg (n = 2). Patients were diagnosed with multiple myeloma (n = 16), non-Hodgkin's lymphoma (n = 12), acute myelogenous leukemia (n = 1), or desmoplasmic round cell tumor (n = 1). Velafermin was well tolerated at doses up to 0.2 mg/kg. There were no drug-related serious adverse events. No patient discontinued because of adverse events; however, two patients administered 0.33 mg/kg developed adverse reactions immediately after infusion of the study drug. No other patients were treated at this dose level. The most frequent (>35% of patients) treatment-emergent adverse events were diarrhea, fatigue, pyrexia, vomiting, and nausea. Most adverse events were mild or moderate and resolved the same day without sequelae. Eight (27%) patients developed WHO grade 3 or 4 OM during the study; seven of these patients received high-dose melphalan as a conditioning regimen. CONCLUSION:
Velafermin was well tolerated by autologous PBSCT patients at doses up to 0.2 mg/kg.
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Authors | Michael W Schuster, Tsiporah B Shore, John G Harpel, June Greenberg, Bita Jalilizeinali, Scott Possley, Robert W Gerwien, William Hahne, Yuan-Di C Halvorsen |
Journal | Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
(Support Care Cancer)
Vol. 16
Issue 5
Pg. 477-83
(May 2008)
ISSN: 0941-4355 [Print] Germany |
PMID | 17710442
(Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents
- FGF20 protein, human
- Fibroblast Growth Factors
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Topics |
- Adult
- Aged
- Antineoplastic Agents
(adverse effects, therapeutic use)
- Dose-Response Relationship, Drug
- Drug Administration Schedule
- Female
- Fibroblast Growth Factors
(adverse effects, therapeutic use)
- Hematologic Neoplasms
(complications, drug therapy, therapy)
- Humans
- Male
- Middle Aged
- Peripheral Blood Stem Cell Transplantation
- Stomatitis
(chemically induced, drug therapy)
- Treatment Outcome
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