Conditions: Neoplasm Oral Mucosa Transplant-Related Disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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.

Interventions: intervention 1: Topical Phenylephrine Solution
Intervention descriptions: intervention 1: Given topically via spray

Protocol document: