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:
University of Medicine and Dentistry New Jersey
Collaborator:
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00004058
First received: December 10, 1999
Last updated: January 25, 2010
Last verified: January 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
essential thrombocythemia
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
polycythemia vera
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Anemia
Bone Marrow Diseases
Cancer
Chronic Myeloid Leukemia
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
U.S. FDA Resources
Further study details as provided by University of Medicine and Dentistry 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) |
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 | 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 University of Medicine and Dentistry 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 May 23, 2013