Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005639
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2000-05-02
Brief Title:
Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase I Dose Escalation to Maximally Tolerated Dose Trial of 5-Azacytidine 5 AC NSC 102816 in Combination With Sodium Phenylbutyrate PB NSC 657802 in Patients With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of azacitidine plus phenylbutyrate in treating patients with advanced or metastatic solid tumors that have not responded to previous treatment
PURPOSE This phase I trial is studying the side effects and best dose of azacitidine plus phenylbutyrate in treating patients with advanced or metastatic solid tumors that have not responded to previous treatment
Detailed Description:
OBJECTIVES
Evaluate the safety and toxicity of azacitidine plus phenylbutyrate in patients with refractory solid tumors
Determine the maximum tolerated dose of this treatment regimen where maximal gene reexpression occurs in these patients
Evaluate the pharmacokinetics of these drugs in these patients
Determine the minimally effective dose of azacitidine in combination with phenylbutyrate that elicits a biological or clinical response in these patients
OUTLINE This is a dose escalation study
Patients receive azacitidine subcutaneously for 14-21 days and sodium phenylbutyrate IV continuously for 1-7 days Treatment repeats every 35 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses and durations of treatment with azacitidine and phenylbutyrate 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 toxicities
PROJECTED ACCRUAL Approximately 3-50 patients will be accrued for this study within 12-18 months
Evaluate the safety and toxicity of azacitidine plus phenylbutyrate in patients with refractory solid tumors
Determine the maximum tolerated dose of this treatment regimen where maximal gene reexpression occurs in these patients
Evaluate the pharmacokinetics of these drugs in these patients
Determine the minimally effective dose of azacitidine in combination with phenylbutyrate that elicits a biological or clinical response in these patients
OUTLINE This is a dose escalation study
Patients receive azacitidine subcutaneously for 14-21 days and sodium phenylbutyrate IV continuously for 1-7 days Treatment repeats every 35 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses and durations of treatment with azacitidine and phenylbutyrate 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 toxicities
PROJECTED ACCRUAL Approximately 3-50 patients will be accrued for this study within 12-18 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 |
|---|---|---|---|
| 99-12-03-02 | OTHER | JHM IRB | httpsreporternihgovquickSearchP30CA006973 |
| U01CA070095 | NIH | None | None |
| R01CA075525 | NIH | None | None |
| P50CA058236 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| CDR0000067799 | None | None | None |
| NCI-270 | None | None | None |