Neoplasm Clinical Trial
Official title:
A Phase I/IIa Safety and Efficacy Study of Topical Phenylephrine Applied to Oral Mucosa in Bone Marrow Transplant Patients Receiving Cytoxan Plus Total Body Irradiation
This phase I/II trial studies the safety of topical phenylephrine solution and to see how well it works in preventing oral mucosa (mouth sores) in bone marrow transplant patients receiving cyclophosphamide and total body radiation therapy. Topical phenylephrine solution may prevent or lessen the severity of oral mucosa in patients receiving cyclophosphamide and total body radiation prior to undergoing a bone marrow transplant.
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of phenylephrine (topical phenylephrine solution)
applied topically to the oral mucosa of bone marrow transplant patients treated with
cyclophosphamide plus total body irradiation.
II. To determine the maximum tolerated dose (MTD) and recommended phase II dose of
phenylephrine applied topically to the oral mucosa of bone marrow transplant patients treated
with cyclophosphamide plus total body irradiation.
III. To evaluate the efficacy of phenylephrine applied topically to the oral mucosa in
preventing and/or decreasing severity of oral mucositis in bone marrow transplant patients
treated with cyclophosphamide plus total body irradiation.
OUTLINE: This is a phase I, dose-escalation study of topical phenylephrine solution followed
by a phase II study.
Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical
phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each
cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide
infusion, and 15-20 minutes prior to each radiation treatment.
After completion of study treatment, patients are followed up weekly for 2 weeks and then at
3 months.
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