Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006239
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2000-09-11
Brief Title:
Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer
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-Finding Trial of Sodium Phenylbutrate NSC 657802 in Combination With All Trans-retinoic Acid ATRA NSC 122758 in Patients With Myelodysplastic Syndromes MDS and Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2017-09
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Tretinoin may help hematologic cancer cells develop into normal white blood cells
PURPOSE Phase I trial to study the effectiveness of combining phenylbutyrate and tretinoin in treating patients who have hematologic cancer
PURPOSE Phase I trial to study the effectiveness of combining phenylbutyrate and tretinoin in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES
Determine the safety and toxicity of phenylbutyrate and tretinoin in patients with myelodysplastic syndromes chronic myelomonocytic leukemia or acute myeloid leukemia
Determine the pharmacokinetic interaction of this regimen in these patients
Determine any potential therapeutic activity of this regimen in these patients
OUTLINE This is a dose escalation study of tretinoin
Patients receive phenylbutyrate IV continuously on days 1-7 of weeks 1 5 7 9 11 13 15 17 and 19 Patients also receive oral tretinoin three times daily on days 1-7 of weeks 3 5 7 9 11 13 15 17 and 19 Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tretinoin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities
An additional cohort of 6 patients is accrued at the MTD These patients receive phenylbutyrate IV continuously on days 1-3 of weeks 1 and 3-18 These patients also receive oral tretinoin three times daily on days 1-3 of weeks 2-18 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for this study within 18 months
Determine the safety and toxicity of phenylbutyrate and tretinoin in patients with myelodysplastic syndromes chronic myelomonocytic leukemia or acute myeloid leukemia
Determine the pharmacokinetic interaction of this regimen in these patients
Determine any potential therapeutic activity of this regimen in these patients
OUTLINE This is a dose escalation study of tretinoin
Patients receive phenylbutyrate IV continuously on days 1-7 of weeks 1 5 7 9 11 13 15 17 and 19 Patients also receive oral tretinoin three times daily on days 1-7 of weeks 3 5 7 9 11 13 15 17 and 19 Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tretinoin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities
An additional cohort of 6 patients is accrued at the MTD These patients receive phenylbutyrate IV continuously on days 1-3 of weeks 1 and 3-18 These patients also receive oral tretinoin three times daily on days 1-3 of weeks 2-18 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for this study within 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 |
|---|---|---|---|
| NCI-T98-0068 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| R01CA067803 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J9879 | None | None | None |
| JHOC-99072306 | None | None | None |