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

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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
Sponsor:
Collaborator:
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:

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.


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





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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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


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 of New Jersey
National Cancer Institute (NCI)
Investigators
Study Chair: Roger Strair, MD, PhD Rutgers Cancer Institute of New Jersey

Responsible Party: Roger Strair, MD, PhD, UMDNJ/CINJ
ClinicalTrials.gov Identifier: NCT00004058     History of Changes
Other Study ID Numbers: 5986; CDR0000067255
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ-059806
UMDNJ-2716
NCI-G99-1573
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:
Lymphoma
Disease
Syndrome
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Plasmacytoma
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Precancerous Conditions
Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders