Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients With Refractory Hematologic Malignancies/Bone Marrow Disorders
tetradecanoylphorbol acetate
Lymphadenopathy+82
+ Amyloidosis
+ Anemia
Treatment Study
Summary
Study start date: December 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, United StatesOpen Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School in Google Maps