Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004058
Status:
TERMINATED
Last Update Posted:
2010-01-26
First Post:
1999-12-10
Brief Title:
12-O-Tetradecanoylphorbol-13-acetate in Treating Patients With Hematologic Cancer or Bone Marrow Disorder
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Phase I Study of 12-O-tetradecanoylphorbol-13-acetate TPA in Patients With Refractory Hematologic MalignanciesBone Marrow Disorders
Status:
TERMINATED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
At this time it is felt that we will not gain further information from an additional patients
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
PURPOSE This phase I trial is studying the side effects and best dose of 12-O-tetradecanoylphorbol-13-acetate in treating patients with hematologic cancer or bone marrow disorder that has not responded to previous treatment
PURPOSE This phase I trial is studying the side effects and best dose of 12-O-tetradecanoylphorbol-13-acetate in treating patients with hematologic cancer or bone marrow disorder that has not responded to previous treatment
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose limiting toxicity of 12-O-tetradecanoylphorbol-13-acetate TPA in patients with relapsed or refractory hematologic malignancies or bone marrow disorders
Determine the pharmacokinetics of TPA in these patients
Determine the effects of TPA on the cellular composition of blood and bone marrow in these patients
OUTLINE This is a dose-escalation study
Patients receive 12-O-tetradecanoylphorbol-13-acetate TPA IV over 1 hour on days 1 and 8 followed by 2 weeks of rest Courses repeat in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of TPA until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity
PROJECTED ACCRUAL Approximately 36 patients will be accrued for this study
Determine the maximum tolerated dose and dose limiting toxicity of 12-O-tetradecanoylphorbol-13-acetate TPA in patients with relapsed or refractory hematologic malignancies or bone marrow disorders
Determine the pharmacokinetics of TPA in these patients
Determine the effects of TPA on the cellular composition of blood and bone marrow in these patients
OUTLINE This is a dose-escalation study
Patients receive 12-O-tetradecanoylphorbol-13-acetate TPA IV over 1 hour on days 1 and 8 followed by 2 weeks of rest Courses repeat in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of TPA until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity
PROJECTED ACCRUAL Approximately 36 patients will be accrued for this study
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-G99-1573 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |
| CINJ-059806 | None | None | None |
| UMDNJ-2716 | None | None | None |