Lymphoma Clinical Trial
Official title:
Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients With Refractory Hematologic Malignancies/Bone Marrow Disorders
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.
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.
;
Primary Purpose: Treatment
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