Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients With Refractory Hematologic Malignancies/Bone Marrow Disorders
18 Years
N/A
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Precancerous/Nonmalignant Condition
Trial Information
Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients With Refractory Hematologic Malignancies/Bone Marrow Disorders
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Roger Strair, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Cancer Institute of New Jersey
Authority:
United States: Federal Government
Study ID:
5986; CDR0000067255
NCT ID:
NCT00004058
Start Date:
December 1998
Completion Date:
November 2004
Related Keywords:
- Chronic Myeloproliferative Disorders
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
- Precancerous/Nonmalignant Condition
- 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)
- Bone Marrow Diseases
- Neoplasms
- Leukemia
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Precancerous Conditions
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
