Trials / Terminated
TerminatedNCT00004058
12-O-Tetradecanoylphorbol-13-acetate in Treating Patients With Hematologic Cancer or Bone Marrow Disorder
Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients With Refractory Hematologic Malignancies/Bone Marrow Disorders
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- University of Medicine and Dentistry of New Jersey · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Chronic Myeloproliferative Disorders
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
- Precancerous/Nonmalignant Condition
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tetradecanoylphorbol acetate |
Timeline
- Start date
- 1998-12-01
- Primary completion
- 2004-11-01
- Completion
- 2004-11-01
- First posted
- 2003-01-27
- Last updated
- 2010-01-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00004058. Inclusion in this directory is not an endorsement.