NCT00004058TerminatedPhase 1
Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients With Refractory Hematologic Malignancies/Bone Marrow Disorders
University of Medicine and Dentistry of New Jersey1 site in 1 countryStarted: December 1, 1998Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Locations
- 1
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •Performance status:
- •Life expectancy:
- •Greater than 1 month
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST no greater than 3 times ULN
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •Cardiac ejection fraction greater than 40%
- •FEV_1 greater than 50% predicted
- •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
- •Not specified
- •No other concurrent investigational agents
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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