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Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients With Refractory Hematologic Malignancies/Bone Marrow Disorders


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Precancerous/Nonmalignant Condition

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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 SchoolNew Brunswick, New Jersey  08903