Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002677
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
1999-11-01
Brief Title:
Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
PHASE I STUDY OF THE ORALLY ADMINISTERED BUTYRATE PRODRUG TRIBUTYRIN IN PATIENTS WITH SOLID TUMORS
Status:
COMPLETED
Status Verified Date:
2019-10
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:
Phase I trial to study the effectiveness of tributyrin in treating patients with refractory stage IV prostate cancer or other solid tumors Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose and optimum schedule of tributyrin in patients with prostate cancer or other solid tumors
II Determine the toxic effects of tributyrin in these patients III Determine the pharmacodynamics of tributyrin including modulation of tumor markers evaluation of clinical remission when possible assessment of F-reticulocytes andor F cells and evaluation of hemoglobin F before and after treatment in these patients
IV Determine the pharmacokinetics of tributyrin including maximum plasma concentration terminal half-life area under the concentration time curve volume of distribution and clearance of butyrate in these patients
V Determine the relationship between the pharmacokinetics and toxic or therapeutic pharmacodynamic effects of butyrate in these patients
VI Calculate a tributyrin dose using results from pharmacokinetic and pharmacodynamic studies that achieves sustained butyrate concentrations capable of increasing therapeutic effects with reduced toxicity
OUTLINE This is a dose escalation study
Patients receive oral tributyrin every 8 hours for 3 weeks Treatment continues every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Patients who achieve stable disease may receive additional courses at the discretion of the protocol chairperson Cohorts of 3-6 patients receive escalating doses of tributyrin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
I Determine the maximum tolerated dose and optimum schedule of tributyrin in patients with prostate cancer or other solid tumors
II Determine the toxic effects of tributyrin in these patients III Determine the pharmacodynamics of tributyrin including modulation of tumor markers evaluation of clinical remission when possible assessment of F-reticulocytes andor F cells and evaluation of hemoglobin F before and after treatment in these patients
IV Determine the pharmacokinetics of tributyrin including maximum plasma concentration terminal half-life area under the concentration time curve volume of distribution and clearance of butyrate in these patients
V Determine the relationship between the pharmacokinetics and toxic or therapeutic pharmacodynamic effects of butyrate in these patients
VI Calculate a tributyrin dose using results from pharmacokinetic and pharmacodynamic studies that achieves sustained butyrate concentrations capable of increasing therapeutic effects with reduced toxicity
OUTLINE This is a dose escalation study
Patients receive oral tributyrin every 8 hours for 3 weeks Treatment continues every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Patients who achieve stable disease may receive additional courses at the discretion of the protocol chairperson Cohorts of 3-6 patients receive escalating doses of tributyrin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
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 |
|---|---|---|---|
| NCI-T94-0181O | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064322 | REGISTRY | None | None |