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

Primary Purpose

Chronic Myeloproliferative Disorders, Leukemia, Lymphoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tetradecanoylphorbol acetate
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloproliferative Disorders focused on measuring 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, recurrent adult Burkitt lymphoma, recurrent adult T-cell leukemia/lymphoma, secondary acute myeloid leukemia, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, primary central nervous system lymphoma, prolymphocytic leukemia, primary systemic amyloidosis, recurrent mantle cell lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, refractory cytopenia with multilineage dysplasia, recurrent mycosis fungoides/Sezary syndrome, chronic eosinophilic leukemia, chronic neutrophilic leukemia, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
January 25, 2010
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004058
Brief Title
12-O-Tetradecanoylphorbol-13-acetate in Treating Patients With Hematologic Cancer or Bone Marrow Disorder
Official Title
Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients With Refractory Hematologic Malignancies/Bone Marrow Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Terminated
Why Stopped
At this time it is felt that we will not gain further information from an additional patients.
Study Start Date
December 1998 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Precancerous/Nonmalignant Condition
Keywords
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, recurrent adult Burkitt lymphoma, recurrent adult T-cell leukemia/lymphoma, secondary acute myeloid leukemia, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, primary central nervous system lymphoma, prolymphocytic leukemia, primary systemic amyloidosis, recurrent mantle cell lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, refractory cytopenia with multilineage dysplasia, recurrent mycosis fungoides/Sezary syndrome, chronic eosinophilic leukemia, chronic neutrophilic leukemia, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tetradecanoylphorbol acetate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Strair, MD, PhD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

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

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