RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of 12-O-tetradecanoylphorbol-13-acetate in treating patients who have hematologic cancer or bone marrow disorder that has not responded to previous treatment.

Condition	Treatment or Intervention	Phase
chronic myeloproliferative disorders Leukemia Lymphoma myelodysplastic and myeloproliferative diseases plasma cell neoplasm	Drug: 12-O-tetradecanoylphorbol-13-acetate  Procedure: chemotherapy	Phase I

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

New Jersey
      Cancer Institute of New Jersey at Robert Wood Johnson University Hospital, New Brunswick,  New Jersey,  08901,  United States; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000067255; CINJ-059806; UMDNJ-2716; NCI-G99-1573
Record last reviewed:  November 1999
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004058
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22