Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330382
Status:
COMPLETED
Last Update Posted:
2014-12-19
First Post:
2006-05-25
Brief Title:
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Bowman Birk Inhibitor Concentrate and Oral Leukoplakia A Randomized Phase IIb Trial
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works in preventing cancer in patients with oral leukoplakia Chemoprevention is the use of certain substances to keep cancer from forming growing or coming back The use of Bowman-Birk inhibitor concentrate a substance made from soy may keep cancer from forming in patients with oral leukoplakia
Detailed Description:
PRIMARY OBJECTIVES
I Determine if chemoprevention by the Bowman-Birk inhibitor concentrate BBIC can prevent cancer in patients with oral leukoplakia OL
II Determine the clinical and histologic response rate of OL to BBIC
SECONDARY OBJECTIVES
I Measure the effect of BBIC on intermediate marker endpoint levels II Correlate the clinical and histologic responses of OL with cellular levels of proteolytic activity erb-B2 neu retinioc acid receptor β bcl-2 and mutant p53 expression and serum levels of neu
III Determine the individual and group side effects of BBIC
OUTLINE This is a multicenter randomized double-blind placebo-controlled study Prior to randomization all patients receive oral placebo for 4 weeks Patients who show good compliance 75 packet count are randomized to 1 of 2 treatment arms
ARM I Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months in the absence of disease progression or unacceptable toxicity
ARM II Patients receive oral placebo twice daily for 6 months in the absence of disease progression or unacceptable toxicity
Patients complete questionnaires about diet tobacco and alcohol usage at baseline and at the completion of study treatment Blood urine and biopsy tissue are collected at baseline and at the completion of study treatment Oral mucosal cells are collected at baseline during the run-in phase at randomization after completion of study treatment and at 3 months after completion of study treatment Samples are examined for protease activity levels of bcl-2 and erbB-2 mutant p53 oncogene expression and epidermal growth factor receptor and retinoic acid receptor-β expression
After completion of study treatment patients are followed at 3 months
I Determine if chemoprevention by the Bowman-Birk inhibitor concentrate BBIC can prevent cancer in patients with oral leukoplakia OL
II Determine the clinical and histologic response rate of OL to BBIC
SECONDARY OBJECTIVES
I Measure the effect of BBIC on intermediate marker endpoint levels II Correlate the clinical and histologic responses of OL with cellular levels of proteolytic activity erb-B2 neu retinioc acid receptor β bcl-2 and mutant p53 expression and serum levels of neu
III Determine the individual and group side effects of BBIC
OUTLINE This is a multicenter randomized double-blind placebo-controlled study Prior to randomization all patients receive oral placebo for 4 weeks Patients who show good compliance 75 packet count are randomized to 1 of 2 treatment arms
ARM I Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months in the absence of disease progression or unacceptable toxicity
ARM II Patients receive oral placebo twice daily for 6 months in the absence of disease progression or unacceptable toxicity
Patients complete questionnaires about diet tobacco and alcohol usage at baseline and at the completion of study treatment Blood urine and biopsy tissue are collected at baseline and at the completion of study treatment Oral mucosal cells are collected at baseline during the run-in phase at randomization after completion of study treatment and at 3 months after completion of study treatment Samples are examined for protease activity levels of bcl-2 and erbB-2 mutant p53 oncogene expression and epidermal growth factor receptor and retinoic acid receptor-β expression
After completion of study treatment patients are followed at 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA072294 | NIH | None | httpsreporternihgovquickSearchU01CA072294 |
| 98-34 | None | None | None |