12-O-Tetradecanoylphorbol-13-acetate in Treating Patients With Hematologic Cancer or Bone Marrow Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

1998-12-31

Study Completion Date

2004-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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tetradecanoylphorbol acetate

Intervention Type DRUG

Eligibility Criteria

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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:

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No