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Keep this study
Lead
University of Medicine and Dentistry of New Jersey
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | 12-O-Tetradecanoylphorbol-13-acetate in Treating Patients With Hematologic Cancer or Bone Marrow Disorder
