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

Phase 1TerminatedNCT00004058

University of Medicine and Dentistry of New Jersey

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition

Interventions

tetradecanoylphorbol acetateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically proven relapsed or refractory hematologic malignancy or bone marrow disorder for which there is no standard curative therapy, including, but not limited to: * Myelodysplasia * Multiple myeloma * Myeloproliferative syndrome * Chronic lymphocytic leukemia * Aplastic anemia * Non-Hodgkin's lymphoma * Acute leukemia * Hodgkin's lymphoma * Chronic myelogenous leukemia PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * Greater than 1 month Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 3 times ULN Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * Cardiac ejection fraction greater than 40% Pulmonary: * FEV\_1 greater than 50% predicted Other: * No active infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 10 weeks after study participation * No uncontrolled psychiatric or medical illness PRIOR CONCURRENT THERAPY: Biologic therapy: * Greater than 3 weeks since prior biologic therapy Chemotherapy: * Greater than 3 weeks since prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No other concurrent investigational agents

Locations (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Data from ClinicalTrials.gov

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