Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002909
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
1999-11-01
Brief Title:
Phenylbutyrate in Treating Patients With Refractory Solid Tumors or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE I CLINICAL AND PHARMACOLOGIC EVALUATION OF PHENYLBUTYRATE IN PATIENTS WITH REFRACTORY SOLID TUMORS STUDY OF CONTINUOUS EXPOSURE ORAL PHENYLBUTYRATE ON A THREE TIMES DAILY SCHEDULE
Status:
COMPLETED
Status Verified Date:
2001-02
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:
Phase I trial to study the effectivenes of phenylbutyrate in treating adults with refractory solid tumor or lymphoma 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 of oral phenylbutyrate that can be given three times daily in patients with refractory solid tumors or lymphoma until disease progression or a trough plasma concentration of 2-6 micromoles per liter is achieved
II Characterize the pharmacokinetics of oral phenylbutyrate absorption and determine whether there is time dependence in the systemic clearance rate during multiple dosing
III Seek preliminary evidence of therapeutic activity of phenylbutyrate when administered on this schedule in these patients
IV Correlate any observed responses and toxic effects with results of bioassays and tissue sampling for phenylbutyrate activity
OUTLINE This is a dose-seeking study
All patients receive oral phenylbutyrate three times daily Groups of 4 or more patients receive escalating doses of phenylbutyrate until the maximum tolerated dose MTD is determined Treatment continues until disease progression or unacceptable toxicity intervenes
I Determine the maximum tolerated dose of oral phenylbutyrate that can be given three times daily in patients with refractory solid tumors or lymphoma until disease progression or a trough plasma concentration of 2-6 micromoles per liter is achieved
II Characterize the pharmacokinetics of oral phenylbutyrate absorption and determine whether there is time dependence in the systemic clearance rate during multiple dosing
III Seek preliminary evidence of therapeutic activity of phenylbutyrate when administered on this schedule in these patients
IV Correlate any observed responses and toxic effects with results of bioassays and tissue sampling for phenylbutyrate activity
OUTLINE This is a dose-seeking study
All patients receive oral phenylbutyrate three times daily Groups of 4 or more patients receive escalating doses of phenylbutyrate until the maximum tolerated dose MTD is determined Treatment continues until disease progression or unacceptable toxicity intervenes
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 |
|---|---|---|---|
| CDR0000065274 | REGISTRY | PDQ Physician Data Query | None |
| NCI-T95-0017H | None | None | None |
| J-9616 | None | None | None |
| JHOC-9616 | None | None | None |