Expired Study
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New Brunswick, New Jersey 08903


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00004058


Primary Contact:

Study Chair
Roger Strair, MD, PhD
Cancer Institute of New Jersey


Backup Contact:

N/A


Location Contact:

New Brunswick, New Jersey 08903
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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