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| Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004058 |
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 I |
| Study Type: | Interventional |
| Study Design: | 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 |
OBJECTIVES:
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 |
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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Study Chair: | Roger Strair, MD, PhD | Cancer Institute of New Jersey |
More Information
| Study ID Numbers: | CDR0000067255, CINJ-059806, UMDNJ-2716, NCI-G99-1573 |
| Study First Received: | December 10, 1999 |
| Last Updated: | January 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004058 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Polycythemia Chronic Myelomonocytic Leukemia Large Granular Lymphocyte Leukemia Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Refractory Anemia Mycoses Acute Myelocytic Leukemia Preleukemia Hemorrhagic Disorders Leukemia, Prolymphocytic Anemia, Refractory Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell |
Neoplasm Metastasis Lymphoma, Large-Cell, Anaplastic Thrombocythemia, Hemorrhagic Hodgkin Disease Myelodysplastic Myeloproliferative Disease Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Blood Coagulation Disorders Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Hairy Cell Leukemia Myeloproliferative Disorders Leukemia, Myeloid |
|
Precancerous Conditions Blood Protein Disorders Paraproteinemias Hemostatic Disorders Leukemia Preleukemia Hemorrhagic Disorders Pathologic Processes Syndrome Cardiovascular Diseases Lymphoma Disease Neoplasms by Histologic Type |
Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Vascular Diseases Multiple Myeloma Lymphatic Diseases Neoplasms Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |
