NCT02434146|TerminatedPhase 1/2ResultsDMC
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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
Sponsor study identifier
Secondary identifiers
OTHER · NCI Trial ID
OTHER · Institutional Review Board
OTHER · UW Madison
OTHER · UW Madison
interventional
3
1 country
1
Study Start
May 14, 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 27, 2016
Actual (reported)Study Completion
January 25, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 25, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 24, 2015
Actual (reported)May 5, 2015
Actual (reported)May 14, 2015
Date type not reportedThis date has not been verified as actual or estimated.
April 27, 2016
Actual (reported)January 25, 2017
Actual (reported)April 27, 2017
Actual (reported)Area Under the Curve (AUC) for the Oral Mucositis Severity
The mucositis AUC will be estimated using the trapezoid method and summarized in terms of means, standard deviation, median and range. This analysis will be performed in both the extended cohort as well as in the historical controls.
Up to 3 months
Duration of Grade 2 Oral Mucositis
If the grade 2 oral mucositis has not been resolved (to a grade \< 2) by the last day of toxicity assessment, then the duration will be censored at the last date of toxicity assessment. Will be analyzed using the Kaplan-Meier method. The median duration of grade 2/grade 3 oral mucositis will be calculated and reported along with the corresponding 95% confidence interval. This analysis will be performed in both the extended cohort as well as in the historical controls.
Date of onset of grade 2 oral mucositis to the date of the resolution of the grade 2 oral mucositis, assessed up to 3 months
Duration of Grade 3 Oral Mucositis
If the grade 3 oral mucositis has not been resolved (to a grade \< 3) by the last day of toxicity assessment, then the duration will be censored at the last date of toxicity assessment. Will be analyzed using the Kaplan-Meier method. The median duration of grade 2/grade 3 oral mucositis will be calculated and reported along with the corresponding 95% confidence interval. This analysis will be performed in both the extended cohort as well as in the historical controls.
Date of onset of grade 3 oral mucositis to the date of resolution to grade < 3 oral mucositis, assessed up to 3 months
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.
Given topically via spray
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and no study conclusions could be made.
Margo L. Hoover-Regan
University of Wisconsin, Madison
3 participants (actual enrollment reported by the registry).
First Submitted
April 24, 2015
First Posted
May 5, 2015
Study Start
May 14, 2015
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Topical Phenylephrine 2.5% on EVP in Normal Human Eyes
Efficacy Response Rate for Preventing Oral Mucositis With Sufficient Accuracy
If a patient experiences no higher than grade 2 oral mucositis, then s/he will be defined as a responder. If a patient experiences grade \>= 3 oral mucositis, s/he will be defined as a non-responder. Specifically, the efficacy response rate will be estimated with a standard error of less than 15% and the length of the 95% confidence interval will be less than 50%. The efficacy response rate will be summarized in tabular format. The Wilson score method will be used to calculate the 95% confidence interval for the efficacy response rate for the extended cohort.
Up to 3 months
Incidence of Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0
Adverse events (AEs) will be presented in the summary tables by preferred term nested within the System Organ Class. Verbatim description, preferred term, and system organ class for all AEs will be contained in the patient data listings. All AEs occurring after enrollment and throughout the study period will be recorded. Each toxicity event will be assigned an attribution: unrelated, unlikely, possibly, probably, or definitely phenylephrine treatment related.
Up to 3 months
Maximum Tolerated Dose (MTD), Defined as the Highest Dose Level of Phenylephrine Applied to the Oral Mucosa Where 0/3, 0/6, or 1/6 Patients Experience a Dose-limiting Toxicity
Determine Maximum Tolerated Dose (MTD), the highest dose level of phenylephrine applied to the oral mucosa
During the conditioning regimen (radiation and cyclophosphamide treatment), which is anticipated to last 1 week.
Recommended Phase IIa Dose
The dose of topical phenylephrine solution which will be recommended for a larger follow-up phase II efficacy study will be established after the dose cohort at the MTD has been expanded to a total of 12 patients.
During the conditioning regimen (radiation and cyclophosphamide treatment), which is anticipated to last 1 week.
Time to Onset of Grade 2 Oral Mucositis
Will be analyzed using a parametric (one-parameter exponential) cure rate model. Will be performed in both the extended cohort as well as in the historical controls.
Time between the first date of radiation or cyclophosphamide treatment to the date of the onset of grade 2 oral mucositis, assessed up to 3 months
Time to Onset of Grade 3 Oral Mucositis
Will be analyzed using a parametric (one-parameter exponential) cure rate model. Will be performed in both the extended cohort as well as in the historical controls.
Time between the first date of radiation or cyclophosphamide treatment to the date of the onset of grade 3 oral mucositis, assessed up to 3 months
Contact the study team to confirm eligibility.
Primary Completion
April 27, 2016
Actual (reported)Study Completion
January 25, 2017
Actual (reported)Last Updated
December 9, 2019
Results First Posted
April 27, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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