We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004058
Recruitment Status : Terminated (At this time it is felt that we will not gain further information from an additional patients.)
First Posted : January 27, 2003
Last Update Posted : January 26, 2010
National Cancer Institute (NCI)
Information provided by:
Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition Drug: tetradecanoylphorbol acetate Phase 1

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients With Refractory Hematologic Malignancies/Bone Marrow Disorders
Study Start Date : December 1998
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Diffuse Large B-Cell Lymphoma Multiple Myeloma Myeloid Leukemia Acute Myeloid Leukemia Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Monoclonal Gammopathy of Undetermined Significance Chronic Myeloid Leukemia Waldenstrom Macroglobulinemia Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Acute Non Lymphoblastic Leukemia Lymphosarcoma Mantle Cell Lymphoma Follicular Lymphoma Peripheral T-cell Lymphoma Hodgkin Lymphoma Primary Central Nervous System Lymphoma Chronic Lymphocytic Leukemia Chronic Myeloproliferative Disorders Chronic Graft Versus Host Disease Myelodysplastic Syndrome With Excess Blasts Acute Graft Versus Host Disease Aggressive NK Cell Leukemia T-cell Large Granular Lymphocyte Leukemia Primary Myelofibrosis Cutaneous T-cell Lymphoma Polycythemia Vera Burkitt Lymphoma Myelodysplastic/myeloproliferative Disease Anaplastic Large Cell Lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Mycosis Fungoides Hairy Cell Leukemia Adult T-cell Leukemia/lymphoma AL Amyloidosis Essential Thrombocythemia Sezary Syndrome Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Plasmacytoma Chronic Neutrophilic Leukemia Leukemia, T-cell, Chronic Sideroblastic Anemia Pyridoxine-refractory Autosomal Recessive

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • Greater than 1 month


  • 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


  • 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


Biologic therapy:

  • Greater than 3 weeks since prior biologic therapy


  • Greater than 3 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004058

Layout table for location information
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Roger Strair, MD, PhD Rutgers Cancer Institute of New Jersey
Layout table for additonal information
Responsible Party: Roger Strair, MD, PhD, UMDNJ/CINJ
ClinicalTrials.gov Identifier: NCT00004058    
Other Study ID Numbers: 5986; CDR0000067255
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 26, 2010
Last Verified: January 2010
Keywords provided by Rutgers, The State University of New Jersey:
monoclonal gammopathy of undetermined significance
recurrent adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
Waldenstrom macroglobulinemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
polycythemia vera
chronic idiopathic myelofibrosis
essential thrombocythemia
refractory hairy cell leukemia
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
T-cell large granular lymphocyte leukemia
acute undifferentiated leukemia
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Precancerous Conditions
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Pathologic Processes
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders