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

This study has been terminated.
(At this time it is felt that we will not gain further information from an additional patients.)
Sponsor:
Collaborator:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00004058
First received: December 10, 1999
Last updated: January 25, 2010
Last verified: January 2010
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients With Refractory Hematologic Malignancies/Bone Marrow Disorders

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphoma, Small Cleaved-cell, Diffuse Multiple Myeloma Chronic Myeloproliferative Disorders Acute Lymphoblastic Leukemia Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Hodgkin Lymphoma Waldenstrom Macroglobulinemia Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic/myeloproliferative Disease Acute Myeloid Leukemia, Adult Follicular Lymphoma Myelofibrosis Burkitt Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Lymphoblastic Lymphoma Anaplastic Large Cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Hypereosinophilic Syndrome Monoclonal Gammopathy of Undetermined Significance Central Nervous System Lymphoma, Primary Mantle Cell Lymphoma Cutaneous T-cell Lymphoma AL Amyloidosis Leukemia, T-cell, Chronic Essential Thrombocythemia Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Hairy Cell Leukemia Mycosis Fungoides Sezary Syndrome Large Granular Lymphocyte Leukemia Anaplastic Plasmacytoma Polycythemia Vera Sideroblastic Anemia Pyridoxine-refractory Autosomal Recessive
U.S. FDA Resources

Further study details as provided by Rutgers, The State University of New Jersey:

Study Start Date: December 1998
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
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.

PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004058

Locations
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 New Jersey
Investigators
Study Chair: Roger Strair, MD, PhD Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Roger Strair, MD, PhD, UMDNJ/CINJ
ClinicalTrials.gov Identifier: NCT00004058     History of Changes
Other Study ID Numbers: 5986; CDR0000067255, P30CA072720, CINJ-059806, UMDNJ-2716, NCI-G99-1573
Study First Received: December 10, 1999
Last Updated: January 25, 2010
Health Authority: United States: Federal Government

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:
Bone Marrow Diseases
Neoplasms
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Precancerous Conditions
Myelodysplastic-Myeloproliferative Diseases
Hematologic Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on April 17, 2014