eflornithine and Mouth Neoplasms

eflornithine has been researched along with Mouth Neoplasms in 4 studies

Eflornithine: An inhibitor of ORNITHINE DECARBOXYLASE, the rate limiting enzyme of the polyamine biosynthetic pathway.
eflornithine : A fluoroamino acid that is ornithine substituted by a difluoromethyl group at position 2.

Mouth Neoplasms: Tumors or cancer of the MOUTH.

Research

Studies (4)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Clinical Impression From Photographs

"A secondary clinical response measure was bsaed on blinded, comparative judgments of pairs of photographs of the same lesion at baseline and 6 months on study. Picture pairs were assigned to album page, one pair per page, at random. Five physicians experienced with evaluation of oral mucosal tissue abnormalities, but blinded to study arm and time point, independently compared the pictures in each pair using a 7-point scale. The scale ranged from, top photo shows a complete response relative to the bottom photo, through, the same degree of disease is shown by top photo and bottom photo, to bottom photo shows a complete response relative to the top photo. Raw scores were transformed to account for relative position of the earlier and later photo, and averaged across the 5 reviewers. Final scores ranged from one, denoting a CR at 6 months, to 4, which indicated no change, through 7, which indicated that the 6-month photo depicted a much worse situation than the pretreatment photo." (NCT00330382)
Timeframe: Baseline to 6 months

Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)

100% x (Posttreatment value - pretreatment value)/(pretreatment value) (NCT00330382)
Timeframe: Baseline to 6 months

Relative Percent Change in Protease Activity (Delta RFU/Min/µg)

100% x (Posttreatment value - pretreatment value)/(pretreatment value) (NCT00330382)
Timeframe: Baseline to 6 months

Relative Percent Change in Serum Neu Protein (ng/ml)

100% x (Posttreatment value - pretreatment value)/(pretreatment value) (NCT00330382)
Timeframe: Baseline to 6 months

Relative Percent Change in Total Lesion Area After 6 Months on Study

Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area. (NCT00330382)
Timeframe: 6 months

The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen

The reviewer was blinded to study-arm assignment (drug or placebo), but not to time point of specimen. For each specimen, the reviewer marked a continuum to indicate degree of tissue abnormality. The continuum was 140 mm long, and anchored by the word 'Normal' on the left and 'Malignant' on the right. The distance from the left edge of the continuum to the reviewer's mark, in mm, was determined. For analyses, a score was formed by subtracting the pretreatment value from the 6-month value. Thus, a retreat from 'Malignancy' over time produces a negative score, a score of zero denotes no change, and a positive score denotes a worsening situation. Positive values indicate histologic worsening, whereas negative scores denote improvement over the 6-month study period. (NCT00330382)
Timeframe: Baselie to 6 months

Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months

(NCT00330382)
Timeframe: Baseline to 6 months

Number of Participants by Category of Clinical Response at 6 Months

Category of clinical response was based on the magnitude of relative percent change in total lesion area. A complete response (CR) was declared if the relative percent change in total lesion area was minus 100 percent. A partial response (PR) was a relative percent decrease in total lesion area of 50% or more, without being a CR. Disease progression was a relative percent increase in total lesion area of at least 50%. Remaining cases were declared to be stable disease. (NCT00330382)
Timeframe: 6 months

Number of Participants Report at Least 1 Adverse Event During the Study

The onset of adverse event is between the randomizaiton date and off-study date (NCT00330382)
Timeframe: Randomized date to Off-study date, up to 21 months

Reviews

2 reviews available for eflornithine and Mouth Neoplasms

Trials

1 trial available for eflornithine and Mouth Neoplasms

Other Studies

2 other studies available for eflornithine and Mouth Neoplasms