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12-O-Tetradecanoylphorbol-13-acetate in Treating Patients With Hematologic Cancer or Bone Marrow Disorder

2014-08-27 03:58:25 | BioPortfolio

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.

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.

Study Design

Primary Purpose: Treatment

Conditions

Chronic Myeloproliferative Disorders

Intervention

tetradecanoylphorbol acetate

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick
New Jersey
United States
08903

Status

Terminated

Source

University of Medicine and Dentistry New Jersey

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:25-0400

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